Orca1

Data catalog

International device safety notices

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Continuing the International device safety notices list, 1000 records per page.

  1. e0f531cc-00ce-4ff0-669f-39d29439c321
  2. We have received complaints that it is difficult to see when wearing lenses with products…
  3. 445d6552-6296-11e0-7dc1-a128895c66cf
  4. a9ba6d96-1cdd-cb97-517c-c5823245b004
  5. 28423836-7b77-57da-b942-64962082d1cd
  6. The manufacturer, Intersurgical, has notified overseas medical institutions of a problem…
  7. The overseas manufacturer has confirmed that the welding part of the housing part and…
  8. Adapter Optiloc for handpiece, length 26mm
  9. Trilogy 100
  10. cobas 8100 system
  11. bioMerieux Vidas Anti-HBs Total II - ootamatutest koostoimetest tulenevad valepositiivsed…
  12. Merit Maestro , Merit Pursue, Fountain Infusion
  13. CONTRAST MEDIUM, RADIOGRAPHIC, INJECTABLE Bottle, Medication
  14. Zdravotnické prostředky pro diagnostiku a terapii zářením
  15. Technical name: SURGICAL INSTRUMENTS
  16. Elektromechanické zdravotnické prostředky
  17. Due to a problem with the adhesive of the component parts of the target product (repair…
  18. At a medical institution in Japan, the length of the pump tube attached to the cassette…
  19. A medical institution has reported that the silk suture included in the product is of a…
  20. At an overseas manufacturer, two lot numbers of the affected product were found to be…
  21. After conducting an investigation by the manufacturing facility and conducting a leakage…
  22. 673abf77-7956-2211-50c9-5a71f19433a9
  23. e4903ce7-179c-f222-195e-cf6c7618cb98
  24. ae46a1d6-1121-820a-ecdb-547dbb7b497b
  25. 4d607605-2731-fcd5-d149-6130add2a463
  26. As a result of a complaint investigation conducted by an overseas manufacturer, the label…
  27. Subcutaneous leakage was suspected during flushing with physiological saline, so when a…
  28. The manufacturer has informed us that the structure of the pump that sends circulating…
  29. This product is used for retransfusion after suctioning and collecting blood from surgical…
  30. 70524661-f876-9fbe-2081-5b442b8ca0ba
  31. 8c69f7aa-4dd7-9a9b-0a8a-4a1682fa7591
  32. 43614d38-86ea-c6f3-0a8d-e55548e51e0e
  33. 493eaa32-5223-6611-d9eb-e7890321afc7
  34. 91eaf73e-0d5f-b50a-ef19-ddc0e4f701aa
  35. 7f8e1356-91d0-c072-d345-26a2bc1540e2
  36. In the SMART pad cartridge used exclusively for the Philips AED HeartStart HS1, the cart…
  37. Urgent Field Safety Notice for IOLMaster 700 by Carl-Zeiss-Meditec AG
  38. bd4b6fc3-92e2-613a-657b-b7641f718d94
  39. A product is shipped from an overseas manufacturer with a different product code than the…
  40. e9e83953-845a-d33b-9c0f-ec5e6cbe8f4d
  41. 6a60e700-0d66-89ed-42fb-a1a8bec7036f
  42. 1828ed5c-5892-32b2-af81-b41005775922
  43. 6226fdcb-6508-5c3d-3930-9cc042347629
  44. An alarm is issued when one of the two processors that monitors each other goes into…
  45. f56a04bf-c5e6-f7a2-0833-7cc42f05af2f
  46. Regarding this product, we have received information from a customer that the shape of the…
  47. By December 2020, our company will have released Paritex Composite Mesh (Hiare), a mesh…
  48. A medical institution has instructed us to remove the dilator catheter from the delivery…
  49. Two reports from medical institutions have confirmed that certain lot numbers of the COOK…
  50. 843c5117-313c-766f-3c96-5b6cdb2b1b42
  51. This product is an intramedullary nail implant used in femoral fracture fixation surgery…
  52. (a) During the sterilization process of the product, it was confirmed that there was a…
  53. It was discovered that the product was manufactured with a different amount from the…
  54. e73b88b4-52a0-c566-1e29-9107118bb4a6
  55. As a result of an investigation by an overseas manufacturer, soundproofing foam made from…
  56. 81bb304e-4c38-ce7b-25e6-02d2a84d1a66
  57. In the United States, there was one incident where the C-arm of the device did not stop at…
  58. 2f789f65-096a-d2dd-c1da-26e4538830ae
  59. We have received multiple reports of the dilator being scraped off when it was set in the…
  60. 22bdde1c-a8e1-34c5-d09c-aa2c624eed39
  61. 6335e76e-15d9-6804-6259-3c4542ee3800
  62. 4015dd15-1ce5-22c6-fa34-a225ed2a5c24
  63. A product was found to have damaged sterile packaging. Since it cannot be denied that a…
  64. We are conducting a recall because the product may contain a product that is a different…
  65. a26b6633-920c-cff6-4e2c-1cc3187ff02d
  66. There have been reports overseas that the main unit overheated and caught fire due to…
  67. It has been confirmed that some products with "Trocar Kits" had damaged sterile packaging…
  68. c7d00803-8064-9b47-a2cb-ec9c93919d03
  69. Voluntary recall due to the possibility of a product being shipped that does not allow the…
  70. db11f240-8711-4810-3a2f-5a0d8e4ac43b
  71. fd874c14-d444-05cc-8f11-3242491916c3
  72. Manufactured by the target product (sales name: VIZIGO sheath, product number: D138502…
  73. There is a risk of the handle being damaged. There is a possibility that the temperature…
  74. 7bfdedc6-4d33-76fe-47d0-aeeb71adb293
  75. 167f876a-d82f-0e14-caa4-39702697afba
  76. It has been discovered that products with the legal display label of the target lot…
  77. A medical institution has notified us that the medical device was used in the "Blood…
  78. 06f96f9d-b635-40e7-70e7-8583a3e91117
  79. Technical name: Intact parathyroid hormone (iPTH);
  80. Elektromechanické zdravotnické prostředky
  81. 17dbbb19-9c3e-4ac2-79cc-62023e4fa6ca
  82. It has been discovered that some products are erroneously labeled with expiration dates…
  83. 38764da2-65ed-7c57-e716-243ef8f94da1
  84. At a medical institution, we have received a report that the LED pad for optical…
  85. For some products that fall under M1 chip Lot #81060, the manufacturer has found defects…
  86. It has been discovered that there is an error in the serial number written on the product…
  87. 298cbba3-c4e5-8240-0d7d-c4f09a831cc5
  88. 260b3127-a6b2-2c0a-1d7a-04520c8dba7f
  89. Two incidents have been reported overseas where the product disintegrated after use. Since…
  90. A spring (approximately 3 mm) built into the jaw of the sealing device came off during use…
  91. 4f2859ef-3de2-10b3-49fc-1973b50b18b7
  92. It was discovered that the product was manufactured with a different amount from the…
  93. Dräger Disposable Breathing Circuits and Dräger Disposable Breathing Circuits and We have…
  94. A medical institution has informed us that during treatment using this product, the screw…
  95. Due to a defect found in one of the parts that make up this product during the heat…
  96. In some products of the "Extension Tunneler Kit" that comes with this product, both sides…
  97. This product is an internal fixation plate used for maxillary and maxillary bone fixation…
  98. At an overseas manufacturer, some lots of "IntellaNav StablePoint Ablation Catheter" may…
  99. An incident occurred in which a biopsy instrument could not be inserted due to the…
  100. In collecting post-market safety management information at overseas manufacturers, Dräger…
  101. Complaints about black-brown stains on products were reported overseas, and an…
  102. A medical institution confirmed that the product was fixed to a base, matched to the…
  103. Regarding the anesthesia infusion set that we manufacture and sell, we have been contacted…
  104. Regarding the CADD pump infusion set that we manufacture and sell, an overseas…
  105. It has been confirmed that some of the products in question had gel liquefaction. The…
  106. We have received information from a medical institution that this product's stent may…
  107. Overseas manufacturers and suppliers have confirmed that the product can be attached to…
  108. In a specific manufacturing lot of this product, when inserting an intraocular lens, there…
  109. An internal investigation confirmed that the silicone coating process that should have…
  110. The orbital retractor is an orbital retractor that protects the orbital soft tissue and…
  111. d6222d46-c2e8-af0c-1120-a0e0725df162
  112. Some of the screws used to secure the exterior parts of the product are screws that are…
  113. 9017e1f7-a34b-3d5c-c672-6f4dbc4f9159
  114. It was discovered that the product in question may have been contaminated with a product…
  115. 16e3ccec-3f38-b0bd-3c96-b49eacea684f
  116. ddc32a5e-1af4-922d-9d26-17dc9e0b6916
  117. 8275dc80-d885-52a2-10fb-1d0a92773099
  118. I forgot to renew the medical device foreign manufacturer registration for the product…
  119. 3e75d52f-5a46-b847-0206-8039a8f2318a
  120. Regarding the product, the customer has provided information that the number of gold…
  121. When measuring with the blood gas analyzer GASTAT-Pro using the sensor card of a specific…
  122. d7407d7e-2e4b-da17-304a-e991c7ed8d1c
  123. In Japan, only heparin-added dextrose injection has been approved for use as a purge…
  124. cac1fcc2-f107-1bbd-827b-b8ddf012c783
  125. While continuing to monitor complaints collected from the market, we have revised the…
  126. After contacting the overseas manufacturer, it was discovered that the product in question…
  127. 14dadbfb-14d1-2218-4a3d-f6e6cefe73b6
  128. The device provides CEDM (Contrast Enhanced Digital Mammography) with energy subtraction…
  129. 3a106e82-faae-2ec4-eab0-d9dc6640e992
  130. The manufacturing facility has reported that the product was manufactured using a…
  131. It was discovered that the label of the affected product had omitted the legally required…
  132. For eligible products, a standard size 6 product must be packed in a standard size 5…
  133. Display of the secondary packaging (unit box of 30 pieces) of the target product (product…
  134. For K-NOA DOAM, which we manufacture and sell, the chemical immersion time is listed in…
  135. Regarding this product, the manufacturer, B.Brown S.A. Spain, has confirmed that sterile…
  136. Based on the information from the user that the working part (blade part) was broken…
  137. The product was incorrectly labeled with a longer expiration date (February 28, 2026) than…
  138. An incident occurred where the nut that secures this device and the adda stand, which is…
  139. 8bf3a5bb-55b8-afa2-e4b2-d7109444ee5f
  140. caf8f5f7-12dc-53de-4213-f35778d2ab1a
  141. We have confirmed that a product that does not meet product specifications has been…
  142. 3b01c4c8-9fec-265d-044e-581f8e7b3fe6
  143. 9254d9fb-5bf8-98c5-7dbd-bb585a74c89d
  144. During work at a domestic registered manufacturing facility, it was discovered that two…
  145. The lot number stamped on the actual item (23AI01) and the lot number written on the…
  146. It has been confirmed that a product with an incorrect legal label has been placed on the…
  147. When the product was received from an overseas manufacturer, we conducted a visual…
  148. 79144bab-b55c-4884-185d-06ae42777e6c
  149. A product with a different size than the size stated on the product label and the size of…
  150. Technical name: C-Reactive Protein/C-Reactive Protein
  151. 8246afff-66f8-6c1c-26fe-9e3c9603de72
  152. cac91da1-bdaf-c2a5-3e18-74435ef2a049
  153. Some of the target products have been issued by overseas manufacturers due to packaging…
  154. Regarding this product, multiple medical institutions have confirmed that the…
  155. Recently, the Japan Medical Devices Agency (Independent Administrative Agency) has issued…
  156. a8d8e284-b359-9c70-b1e6-c03573afe4e2
  157. While checking the device (demonstration device), some screws came off. Since the…
  158. 54503b69-8a6b-4b96-e386-375102541d93
  159. In response to an increasing number of reports from the market regarding the occurrence of…
  160. For the relevant lot of the product, the expiration date should have been displayed two…
  161. 0f1f70f7-20e4-74e7-2679-858093828c29
  162. Although the manufacturer had relocated, it was discovered that the procedures for…
  163. A foreign manufacturer has requested that the welded part of the housing part and cover…
  164. f27e7658-ad94-9aa3-0304-4f74d0cfcd6f
  165. A battery from an overseas manufacturer with a spot weld touching the insulator of an…
  166. a3571f3a-3fa6-922f-b5e0-f1001cb6240d
  167. As a result of product analysis by the overseas manufacturer, the characteristics of…
  168. dcd2deb2-6327-f11a-f252-de5209ab1936
  169. 364f54ab-7497-6008-1efa-1603955c8eff
  170. 01098798-b57c-bc6c-965c-85d22710a963
  171. Through an investigation by our manufacturer, we have confirmed an issue in the…
  172. When importing measurement data from an ultrasound diagnostic device with the program…
  173. f0529507-6984-4010-963d-8f5325bf5260
  174. 4d07e548-b349-296f-d594-d6858a3ed46f
  175. The facility with a medical device foreign manufacturer registration certificate (design)…
  176. The manufacturer, Intersurgical, has announced that the patient-side connector of this…
  177. (1) Ankylos Fixation Screw Lateral M1.0mm/Hex(*) The raw material of the component is a…
  178. 266790fa-2770-0018-4b39-87b806ea9c85
  179. Regarding the raw materials for the PTFE coating sold under the trade name (1), the PTFE…
  180. 03748169-fd97-13a8-d4ef-d1cadd15ed5f
  181. For the target products, a legal display label is affixed at the originally registered…
  182. c5ca124d-9649-9ceb-598a-69b82fc9ab8f
  183. The shape of the groove on the plate was changed due to a change in the product…
  184. An overseas manufacturer has announced that the 15mm connector connected to this product…
  185. c363b9df-f60d-fd47-2265-caefc01af667
  186. Data measured using the patch-type electroencephalogram HARU-2 updated to firmware version…
  187. As a result of an in-house investigation, it was confirmed that a different coloring agent…
  188. The artificial hip joint femoral stem "Master SL Lateralized" (product number…
  189. It has been found that for devices that have been manufactured for more than three years…
  190. The adult SMART pad cartridge used exclusively for the Philips AED HeartStart HS1 When you…
  191. eaff0ffc-1367-7db1-2bc3-e0af4b7ced25
  192. 22966311-a7f6-79e9-02de-097d5aecc17d
  193. An overseas manufacturer reported a case where the connector connected to this product…
  194. b939271d-6c19-9f7d-9704-67c9b5bef725
  195. 072311e0-051d-ece7-0f22-c92e9204a6b8
  196. e754366b-c7af-5a03-fb65-3cec8a7218dc
  197. In certain series, there is a risk that the stent cannot be deployed if there is severe…
  198. c1b09039-5234-3771-8ae1-7715ae122c59
  199. The item to be collected this time is the electrolyte K electrode comprised in the main…
  200. b67e040f-0ba8-9acf-7445-64f6f82653e2
  201. A product was found to have an abnormality in the board that amplifies the voltage used…
  202. With these products, there have been increasing reports of cases of higher-than-normal…
  203. 601fed09-64df-8b2e-32ec-1af40db4ca85
  204. Regarding the affected product, there have been reports from the domestic market that the…
  205. c3a286d2-e07b-02ee-3f2f-d599651127a2
  206. Regarding the products subject to recall, the sterilization process was re-verified and…
  207. After contacting the manufacturer, we found out that there are three problems with the…
  208. After receiving a complaint regarding accuracy from an overseas customer and analyzing it…
  209. Confirmed cases in foreign countries where the device could not be removed from the…
  210. f9996862-22bd-9b4e-01bb-81ded13cb88f
  211. This lead clipper is an optional accessory for the COOK lead extraction system, and is…
  212. ceb2a279-d756-87a2-5690-6bf19e03bf5c
  213. f81b005a-a671-21fe-0ba5-fa61600e9c21
  214. The magnetic flux density, which is a standard related to product performance and safety…
  215. If you start blood collection after changing the blood collection amount that can be set…
  216. f3312a21-13de-1bf6-b7a7-cf76937ed709
  217. This product is manufactured in the United States, and information such as the model…
  218. Technical name: HIGH DENSITY LIPOPROTEIN (HDL)
  219. Diagnostické zdravotnické prostředky in vitro
  220. f5cd3d25-cc5a-02c5-ff09-c6d888c0dbed
  221. bb68ea60-938b-f90e-89b8-4e902e96798b
  222. When I opened the package from the seller to use the circuit at a medical institution, it…
  223. 381c99ec-5eea-bd73-3541-3a04ec85fd52
  224. KR LimaVit Liner (product number: 6532.54.811) for knee prosthesis tibial components I…
  225. This product is a sterilized, single-use, general-purpose syringe. It was discovered that…
  226. 1ba2ecc9-e0c4-b634-7313-b8f2f51e6517
  227. AR that is outside the approved range in the options of the ligation mode (ligation…
  228. It was discovered that some of the products in the target lot had incorrect product…
  229. The inner blade built into the product (M2 blade) is installed in the correct position on…
  230. e94f2875-2c7c-5bad-b080-73500af7ce0f
  231. The approval details for adding Terfusion infusion set (DEHP-free), which is a kit…
  232. 6503974b-bd67-33b3-8779-9e1d0e021c96
  233. When opening the product box of the target product (1), the medical department received a…
  234. Due to insufficient welding of the obturator tube and sheath lock, the obturator was…
  235. The product contained a model number different from the product name (label) written on…
  236. It contained a monitoring tube connector made of a material different from that stated in…
  237. f3a8a496-afb6-af74-3a74-880a2f66f655
  238. The product (Bone Profiler 5.0 (for 3.3mm)) is used with a special pin as the axis, but…
  239. Voluntary recall of PDS suture thread and PDS Plus as it was thought that the knot tensile…
  240. This product is used for mixing bone cement and injecting it into the surgical site in…
  241. 9f649d5a-3e4c-fa85-5171-4b9073af5009
  242. We have been informed by an overseas manufacturer that some products may have been shipped…
  243. a6fb144d-9bed-1fbd-2841-f3271fb018b7
  244. 98d63eda-f879-8cc6-bcee-ce862679dda8
  245. ff57b41f-7dd3-f59f-f36d-46335c070f9e
  246. An abnormality was found in the optical calibration parameters of this product. It was…
  247. Accelerator APS -FSN 1, Accelerator APS - Attachment
  248. We received information from a medical institution that ``there were some products whose…
  249. ee2fd84f-d38f-d0fb-3b77-6ce10da2b85c
  250. One of the components of the kit products we manufacture is the "Micro Feather Plastic…
  251. The "single-use ophthalmic knife" manufactured by Feather Safety Razor Co., Ltd. is…
  252. 26bf2fa0-3134-4da2-07e5-11ddf223b168
  253. 226913b4-d8d0-6211-bd4f-e895d2a50bf0
  254. a7cbe8a3-ef53-aa1b-cbc3-2d7aa9d41116
  255. 6e964dca-224c-69b4-2698-7acd9524adfe
  256. In response to reports overseas that ``the curved shape of the tip of the displayed…
  257. Feather Safety Razor Co., Ltd., which manufactures and sells the "Micro Feather Plastic…
  258. An investigation at the manufacturing site revealed that some defective products caused by…
  259. 212d0e43-8fb1-a02b-c7fe-235cdc483017
  260. Regarding the "Micro Feather Plastic Handle" (medical device), which is a component of the…
  261. As a result of a complaint investigation conducted by an overseas manufacturer, certain…
  262. 16-70-00
  263. We received a report from the market that the infusion filter set in the product was not…
  264. We have been informed by the market that the product is packaged with a different type of…
  265. 24d54b07-fef9-c73a-ab28-1e989092709b
  266. 55a1c4fb-dccb-f681-4c28-dbd59bcf095b
  267. This product is used in conjunction with a bipolar generator to coagulate biological…
  268. It was confirmed that a different standard of stainless steel was used in a particular…
  269. ea16f6fd-eaf8-6823-e190-48fb84ca05ae
  270. It was confirmed that a product manufactured at a registered manufacturing facility not…
  271. A medical institution requested that the tube and lock connector be connected to each…
  272. a9216cbf-b4a5-096a-14d5-2b6f4303dcf5
  273. This product is used to fill fracture gaps and protect fracture sites from stress during…
  274. e5a42366-2722-0f82-bd56-f1b7f267aaa8
  275. Regarding the "Terfusion pump infusion set" (medical device), which is a component of the…
  276. 7b632b4b-3054-964f-4e7b-8de5ecf5a360
  277. A customer told us that the tip diameter size of the product on the label and the product…
  278. Domestic medical institutions have reported cases of contamination with products of…
  279. Regarding Jelco I.V. Catheter II, which we manufacture and sell, we receive a specific lot…
  280. c360a69d-4edd-5a83-2ecf-694abe04d1d0
  281. We have determined that a portion of the product may fall into the patient's body, so we…
  282. During an investigation by an overseas manufacturer, damage to the metal pins of the…
  283. An investigation by the overseas manufacturer confirmed an electrical failure in the…
  284. Among the SB fixes, foreign objects were found in the inner packaging sterilization bag of…
  285. cd51b02f-884e-b70d-1eb9-516b9710886b
  286. Technical name: Reag for immunohematology - Reag of red blood cells/red blood cells…
  287. Diagnostické zdravotnické prostředky in vitro
  288. Retrieval was performed because some of the blades had a blunt part, which could result in…
  289. Regarding the remanufactured medical device "Remanufactured Trocker E (Hogi)", the…
  290. For this product, the module unit (hereinafter referred to as module) is inserted into the…
  291. In-house testing of the product confirmed that the endotoxin level exceeded the standard…
  292. There was a deviation from the storage temperature conditions stated in the precautions…
  293. As a result of investigating defect reports received from the market at overseas…
  294. afa90097-4c85-95a5-f08f-288cce910174
  295. 821e2b79-ee7a-f1ec-2ef6-b622d8dcdee6
  296. It is used to be placed in the bile duct for the purpose of dilating the bile duct or…
  297. This product supplements the initial fixation of a PS cemented femoral component to the…
  298. 6d2ed400-bb79-3ea6-6da9-d6671bffb783
  299. 89a25ece-e06e-c430-dfec-1de2868736d1
  300. Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS
  301. c4278d19-6251-9f67-c302-5abffd333b4f
  302. In some MOMA Ultra products, there is a mistake in pasting the seal on the inflation port…
  303. A person with special approval for foreign-manufactured medical devices said, ``This is an…
  304. We received a report from a medical institution that the visual part was severed and…
  305. Some serial numbers of this product incorporate parts that deviate from the…
  306. Based on the information from the user that the brush connection part was found to be…
  307. We received a report from an overseas manufacturer that the clip could not be removed from…
  308. For the target product, we applied for partial change approval to add a manufacturing…
  309. 57f4ea9b-f8fe-8a0f-b4ae-369fdb5fc2ff
  310. It was discovered that the expiration date of the product in question was incorrectly…
  311. 6369eff9-6bf1-fc29-b822-d8ce95e693ed
  312. 477fdc20-957f-5489-2df2-dcd0cd9da058
  313. There is excess plastic due to a defective shape of the product (CBm blade), and the blade…
  314. Regarding lot 1D01 of the product, it was discovered that there was a discrepancy in the…
  315. On August 3, 2020, we received a complaint that an alarm indicating an abnormality in the…
  316. f60ecf3c-542b-f151-3132-bc8a91779ef9
  317. ed74ba98-02ea-0a9f-3105-6ef6eb5adbbe
  318. 7d9fb48f-fc52-8b95-385d-becfbfff6890
  319. We received a message from a user of the product that the injection needle could not be…
  320. Some batches of this product may not meet design requirements, resulting in leakage from…
  321. The manufacturer has found a vulnerability in some of the products in the target lot, and…
  322. Products manufactured in a registered manufacturing facility that performs the main…
  323. 5f7607bc-c0d4-4c12-d28e-d60628e7689c
  324. bfcf8328-4969-a2e2-4d35-0abb013836db
  325. As part of its internal complaint investigation, foreign manufacturer ResMed Pty Ltd…
  326. When setting the flow rate including the first decimal point, the value after the decimal…
  327. Urgent Field Safety Notice for Vantage Galan,Vantage Centurian,Vantage Titan by Canon…
  328. Medical institutions have confirmed that the arrangement of two holes provided for…
  329. bbe16202-ff26-2113-e463-adb9f5893123
  330. We have received a report of a problem where the ring part (bag part) of this product…
  331. f906fb04-8687-7f71-666e-573a619655a6
  332. 34d02c32-4a38-b315-3f53-a828b45dda9e
  333. Urgent Field Safety Notice for RayCare 5A, 5B, 6A by RaySearch Laboratories AB
  334. 97b2ad56-e3c1-c185-2666-975a77d4be1d
  335. As a result of an investigation at the overseas manufacturer, it was determined that the…
  336. The manufacturer has informed us that some production lots contained hose components that…
  337. It was confirmed that an error related to the pressure sensor was displayed on the…
  338. c8b27d6d-0fd7-7cdf-efef-c58e88fdb2ab
  339. 64941d23-23a8-b376-3fe9-04bd9aa48f12
  340. The M-LNCS reusable sensor TC-I manufactured and sold by our company. It has been reported…
  341. This product is used for bone fixation after trauma, reconstruction, or osteotomy of the…
  342. d4cb0345-8496-3a48-966c-573f1d6aa38e
  343. 53909d53-4cc4-f789-f15c-06964d24df35
  344. It was discovered that the domestic medical device manufacturer's registration for the…
  345. fdda2e45-b73c-e798-9e9f-1e80642b8d54
  346. There have been reports from medical institutions that the soles of the shoes have peeled…
  347. This product is used when intubating a tracheal tube. We have recently discovered that…
  348. The general name of these products is non-active contact acupuncture, but the purpose of…
  349. d2ca8b2b-ea91-b079-bc5c-13df9c373651
  350. This product is used to transfer root canal filling material to the root canal. Some…
  351. f8b5168e-ee9c-8367-cb4e-1504f4535a6c
  352. e12db8a7-e4f3-f3c6-854c-0323b2d6464f
  353. Technical name: Equipment for Immunohematology
  354. Diagnostické zdravotnické prostředky in vitro
  355. There have been reports from medical institutions of poor balloon expansion and deflation…
  356. 8c8dda88-3eed-c617-61f2-d79574ea8170
  357. 3aec77f0-8de0-09c3-19b3-9f4eff7ee11f
  358. 8a845961-59e0-9192-fe44-f4c37a4e3cdd
  359. After researching overseas manufacturers, we found that different sizes of outer needles…
  360. In the target product, the model (version) of the monitor, which is the main component, is…
  361. In this lot, it was confirmed that leaks occurred due to loose connections depending on…
  362. We have decided to voluntarily recall the product as it was discovered that the product…
  363. For certain lots of covered products, the purpose of attaching a reference frame to a…
  364. For the product manufactured by a specific manufacturing unit from a foreign manufacturer…
  365. Urgent Field Safety Notice for CareLink Personal, CareLink System by Medtronic Minimed
  366. 02ac0dc1-3a2f-e3af-7749-b2ba05564c17
  367. We have confirmed the shipment of products that do not comply with the maximum magnetic…
  368. fb388317-a62f-6a1a-ed23-2c61d8dea687
  369. We found that there was a processing defect in the process of manufacturing this product…
  370. Replacement kit for bumper button type 28Fr of "BSC Gastrostomy System (Microvasive…
  371. b2657259-fd00-1f03-1c70-69ee0d0f9b07
  372. As a result of investigating defect reports received from the market at overseas…
  373. fed7674d-1113-1dc8-9bb4-7aaa40decd5e
  374. For the products subject to recall, we were unable to obtain sufficient proof in the…
  375. An investigation by overseas manufacturers revealed that certain production lots of the…
  376. b04c29ed-8931-3938-46cf-67a1a58e3e61
  377. 16dc61b9-ab40-a82e-86c2-8b85cb030d2a
  378. 181411e1-cd61-ad71-6993-91b5d822b50f
  379. A medical institution has pointed out that the part that connects the insulator of the…
  380. For products manufactured between May 10, 2023 and June 10, 2023, there may be machine oil…
  381. e43958ee-928c-faaa-16fd-516ea8b89a6d
  382. 21fc302c-5325-9444-2830-d8f28f9f69c4
  383. Urgent Field Safety Notice for Artiset HD DNL HC by Gambro Dasco S.p.A.
  384. Urgent Field Safety Notice for ORTHO Optix Reader ORTHO BioVue Cassettes by Ortho-Clinical…
  385. d51a9459-53bd-d477-a244-9fc5af814358
  386. 8298b7cf-667f-7491-9f40-0418c8e7d0ae
  387. Based on the survey results of overseas manufacturers, the INVOS Adult N Sensor (P…
  388. Reports regarding discoloration of the delivery pusher of this product have been confirmed…
  389. b47b31e0-62b5-3e11-8796-fbd6c9db588a
  390. A medical institution has pointed out that the connection between the trocar needle and…
  391. 316b8307-26d4-2ae0-0228-c89468b07aeb
  392. Manufacture of products using coloring materials different from those listed in the…
  393. The foreign manufacturer of the product, Dutch Ophthalmic Research Center International…
  394. A medical institution has advised us that during treatment using artificial bone (trade…
  395. 1e565315-9a09-c7f8-9c17-fd09de6285a6
  396. A product labeled with a 3x magnification rate may be packaged with DermaCarrier II, which…
  397. The product requires considerable force when pushing and pulling the piston/knob of the…
  398. 58432e91-642b-3747-44b1-5ccf74865e73
  399. 97454baa-996a-da5d-915d-2e794d916387
  400. b068bedb-e50d-d332-a78c-2e8b9d88bf2a
  401. Each side of the individual packaging materials for this product is completely sealed by…
  402. Medical institutions in Japan have announced that it is difficult to pass the guide wire…
  403. Medical institutions in Japan have reported cases where it is difficult to pass the guide…
  404. The inside of the product is not sufficiently sterilized due to the presence of gaps…
  405. f114f062-0a48-4ace-3b92-d8a4d0521b6e
  406. 63a0f590-6752-d643-5694-980372e2045f
  407. As a "glass thermometer," this product must be inspected based on the Measurement Act and…
  408. Concerning polypropylene, the raw material for this product, a product that uses raw…
  409. The manufacturer has reported that this product may cause double image artifacts during…
  410. fc555cfe-4296-98af-f5ff-9bd617cb9ebb
  411. At an overseas manufacturer, an impression coping screw was inserted into the hole due to…
  412. 14219601-1e64-50b6-6765-77a17fb5f491
  413. b7c1a8ea-c1e5-178a-80c6-bafd4d9ce9ab
  414. ``POLARSHEATH Stealable Sheath'' (hereinafter referred to as ``POLARSHEATH Stealable…
  415. There was one report that white smoke was generated when this device was left on a desk…
  416. 5d994014-2e2c-3519-7090-8a1a974e3004
  417. 96950814-f21b-29d3-f22a-3cb537602104
  418. We are implementing a voluntary recall of the sterilized Kendaku Bottle B type 100ml due…
  419. In version 2.0 or 2.0.1 of the target product's software "Stealthstation S8 Application"…
  420. Due to product testing at overseas manufacturers, the articulation of certain lot number…
  421. Trade name: FLEXIBLE MILLING Ø 8.0 X 360 MM
  422. Diagnostické zdravotnické prostředky in vitro
  423. When using this device, we have confirmed that there are some cases where the tip of the…
  424. A guide guide is used during the placement of the "Standard Peg System (Push method)"…
  425. A case in which a 7Fr. pigtail catheter (polyethylene type), one of the components of the…
  426. Urgent Field Safety Notice for Hookup by Medivators (Cantel Medical)
  427. One of the components of our company's "Pigtail Catheter" is the Pigtail Catheter 7Fr…
  428. One of the components of our company's "Pigtail Catheter" is the Pigtail Catheter 7Fr…
  429. One of the components of our company's "Pigtail Catheter" is the Pigtail Catheter 7Fr…
  430. An overseas manufacturer has informed us that raw materials that have not gone through the…
  431. 2fbff771-b0ee-9d30-3dd1-e0560c93bbc0
  432. f156271a-80bb-03ba-41fe-ca1d41e30e4c
  433. When we checked the abutment (sales name: Neodent GM Healing Abutment) from a medical…
  434. 1 lot of Ospica Heart Wire (Model: TME67ZC) from a domestic trading facility…
  435. For some Attain Balloon Catheter products, the raw materials used in the balloon are…
  436. The noise suppression capacitor used in the control parts was damaged. Unusual behavior…
  437. ce7399df-1821-0c60-d2ee-859b513c7d77
  438. An issue occurred where the adapter for the MAJ-2318 water filter came off from the filter…
  439. The raw materials used for the tip of the delivery sheath of this product were shipped…
  440. There is a clamper that has the function of cutting off the blood circuit when an…
  441. 7a353aa1-11f3-797d-3cb7-58e6c10b4496
  442. 5dfb44f3-7cf8-7d84-f827-241c081175c9
  443. It was confirmed that the stickers were pasted as "right" and "right" on the electrode…
  444. Urgent Field Safety Notice for ROSA One by Medtech SA
  445. Urgent Field Safety Notice for Aquilex Fluid Control System by W.O.M. World of Medicine AG
  446. In some lots of "Opticross Ultrasonic Imaging Catheter" (hereinafter referred to as "this…
  447. 2e363ffc-4188-87af-e19d-6f4ca6cff89c
  448. 7917e8df-df99-2949-5760-f573382e1259
  449. 0f365f23-567f-6ba9-cf28-e42ca8488407
  450. 91b3e3a9-c46e-7d70-a659-13e564a5b747
  451. After researching overseas manufacturers, we found that the settings were originally set…
  452. We received a report from a medical institution regarding a hose crack caused by the…
  453. This product is an intramedullary nail implant used in femoral fracture fixation surgery…
  454. 0428dba0-0158-ca1b-dd15-b4176a98e56e
  455. Because it is not possible to confirm the shipping judgment record of this product, and…
  456. 612c5a52-cafa-d689-b2be-092ec625d0ac
  457. As a result of an investigation by the overseas manufacturer, the following malfunction…
  458. It was discovered that a product that may not meet the bending strength standard value…
  459. This product assumes that it will be used in applications where the blade part is subject…
  460. 4c73eb40-e9bb-653d-0aee-5094aa05fdb2
  461. d03b0449-d4bf-6964-82ee-c72791ff78e9
  462. It has been discovered that some cannula products may have insufficient adhesive in their…
  463. 6a30c66a-1d67-6559-0edf-32628fc27246
  464. 4a5f3f8c-1264-4e01-80ed-6a35187a1d0a
  465. The fuse holder, which was replaced with a substitute from November 2023 to resolve the…
  466. Users of this product have reported that the lock release button for releasing the movable…
  467. We are conducting a voluntary recall because an overseas manufacturer has reported a…
  468. a3da30f7-3698-228f-5d8e-8ca8d4f5c63b
  469. In response to complaints that the casing (battery pack) of this product opens overseas…
  470. 4ca656e3-03c3-ec77-8363-2b4448deedfb
  471. Recently, it was discovered that a 1.2mm post was mixed in with the product in the target…
  472. There is a possibility that the screw hole of the locking plate for the distal lateral…
  473. c8ce6e88-8428-88b4-dcf1-6c29ec53f541
  474. This product is used by connecting to a centrifugal pump drive device for extracorporeal…
  475. For the products subject to recall, we were unable to obtain sufficient proof in the…
  476. 8e16b12d-97fa-e1a7-1715-9c907a227a0c
  477. Applied medical resources, a foreign manufacturer, has provided certain loads of Epix…
  478. f8c13229-69cd-841c-1e84-c455185638ee
  479. 20d7de08-0214-8639-2670-c312c7eeb0ac
  480. 1301b5ad-7de1-767d-1fc6-0cf6fc714c1b
  481. Acriva's "Hemochron Test Cartridge (Model: JACT-LR)" was purchased from a domestic…
  482. The fiber metal pad may not be properly welded to this product, so it will be recalled.
  483. This product is intended to provide an audible alarm to the user under certain conditions…
  484. In the three types of bottles (EG-111A, EG-120A, EG-121A) that are the components of the…
  485. Because it is not possible to confirm the shipping judgment record of this product, and…
  486. Because it is not possible to confirm the shipping judgment record of this product, and…
  487. 0083c488-ea09-3900-259a-6ac9a3a93385
  488. e950a448-b4ee-f278-fe44-1ef6911f61d9
  489. 7b2a54d9-02e7-623d-fd91-b2f4c4584857
  490. Technical name: Glucose
  491. Zdravotnické prostředky v nemocničním vybavení
  492. A component of a sheath assembly for percutaneously delivering a snare (wire tube…
  493. d00064b4-84db-e0b3-0ead-f084fb9440a0
  494. Some of the parts that make up the FDG synthesis cassette were found to have been made by…
  495. We cannot deny the possibility that abrasion powder from the fluororesin packing got into…
  496. 840ecc00-8afe-b6f8-9fc4-fb461fb2d78f
  497. 688740ea-9d00-9878-0203-b3996ed573a1
  498. ed696165-0676-f6d0-d788-2eb47af08b7e
  499. The adapter sleeve, which is a component of the X-guide component, may have been…
  500. 9cf6a9d7-c897-3124-ec84-34d481e15561
  501. In overseas markets, cerebrospinal fluid leaked from the proximal part of the catheter…
  502. 87d11074-4265-7271-c2ff-caca821d79c7
  503. Communication from the manufacturer confirms safety parameters tested by the Beam Access…
  504. 33d630c2-7154-7428-f314-28c015e890fa
  505. Products manufactured before October 2019 due to a defective pressure sensor in the…
  506. Target product software "StealthStation S8 Application" version 1.0.1, 1.0.2, 1.0.3, 1.1.0…
  507. We received a report from an overseas manufacturer (Germany) that the product is suspected…
  508. A medical institution has requested that it is not possible to combine the appropriate…
  509. An investigation by an overseas manufacturer revealed that some of the 1 lot number…
  510. In response to reports that the X-ray opaque marker connected to the delivery pusher…
  511. Regarding the PORTEX/tracheostomy tubes that we manufacture and sell, we receive a…
  512. It has recently come to light that the target lot may contain discs with the front and…
  513. We received a report from a customer that the needle part came off from the Huber needle…
  514. Connector tubing 1/2 x 1/2 inch.
  515. Masimo allows certain Masimo SET Rad-G series (hereinafter referred to as Rad-G) to be…
  516. fc9b616a-5eca-2ebb-413c-41953b1f37a3
  517. This device is used by attaching it to a portable or in-hospital oxygen cylinder. Two…
  518. When using this product, we have confirmed a problem where a higher than expected current…
  519. efc4c234-fde4-fc01-c0c1-5fb94239b172
  520. An overseas manufacturer has informed us that some parts of this product may not be coated…
  521. We have received a report that there is a step at the tip when the dilator, which is a…
  522. c338cbd4-e4dc-b0d7-2096-16ea10c557de
  523. Although the foreign manufacturer responsible for the design and the foreign manufacturer…
  524. A program in which the image orientation label on the screen does not change when the…
  525. As a result of research at overseas manufacturers, all V60 ventilators provide power to…
  526. For some serial numbers of OLYMPUS hysteroresectoscopes, water leakage tests are not…
  527. As a result of an investigation by an overseas manufacturer, it was found that an…
  528. 243d10f9-7638-f4d6-93ea-650c3e8f5691
  529. For some products of Tahni Quick Set (19cm x 2) of DLP cardioplegia fluid infusion…
  530. 7eccbb12-a4bf-0288-1187-6d7f95533631
  531. ab15a4de-0b8e-667b-84df-70d3af40f8d3
  532. c16ab7dc-16df-f23d-44a0-c1a1d2b196f2
  533. During internal confirmation testing, due to a problem with the built-in software, air…
  534. 5c89775a-97e9-6ffc-1ca2-41dddd7ce85a
  535. After receiving reports of burns occurring in multiple cases of children using this…
  536. During the manufacturing process, damage (holes) were found in the sterilized packaging of…
  537. 00b64cce-fc62-743b-8664-430dc69f0051
  538. Disks for antibiogram Temocillin 30 μg
  539. We found some products with defective heat seals on their packaging bags, so we are…
  540. 5d523512-fb79-2001-9836-499d9be8aad9
  541. Fundus tomography scanning scan pattern of fundus radial scan 9m using "3D fundus imaging…
  542. 26c345f2-1e0d-c1f8-78e5-3a9abca9263b
  543. As a result of durability tests on the product, the resistance value of some of the…
  544. We are currently manufacturing and selling "Treatment Pack" (laser lens for eye surgery…
  545. 72bc3692-3a5a-9c98-c0c2-e2323f6e2855
  546. 88a6759d-7bb1-9388-7d66-bc22e9eb92f2
  547. It has come to light that a product was shipped with a validity period shorter than the…
  548. e0291525-972a-76c4-3d27-b8ca0b841474
  549. A voluntary recall was implemented because some raw materials were changed and an…
  550. Post-market surveillance identified issues related to the safe use of this product…
  551. Technical name: Collectors
  552. Zdravotnické prostředky pro diagnostiku a terapii zářením
  553. 7a6afce7-6d04-9dfb-6985-3f5faedbcfaf
  554. Urgent Field Safety Notice for TRACOE vario P-Tube, TRACOE experc Set vario by TRACOE…
  555. e092fe26-6b4a-4b82-82c4-57cd286f113c
  556. 2b5fdf9d-80fd-51a4-2423-f21cfbc06763
  557. Our company manufactures and sells daily disposable soft contact lenses "Seed 1dayPure…
  558. Urgent Field Safety Notice for Cardiosave Hybrid/Rescue IABP by Maquet (vorher: Datascope…
  559. For products manufactured on January 31, 2024, there was an error in the effective date…
  560. Regarding this product, we have received a report that a crack has occurred in a specific…
  561. 07c03ed1-5e6b-80f9-fc4c-32bbca16e344
  562. db5e346c-29c3-f56f-18cb-72f67a5614c6
  563. 30d448d8-ee8b-1afa-b76c-5c3f11e282aa
  564. Due to damage (penetration scratches) confirmed in the sterilized packaging of some…
  565. During the power inspection during the manufacturing of the product, the lens power after…
  566. 3ea661bb-02af-29e3-5a06-28863db69289
  567. adcd839f-77ee-49cc-a814-6671445750fd
  568. The concentration of the standard gas used for calibration was outside the standard value…
  569. ec93688e-490b-947d-423d-8dd857480357
  570. Some adhesives were not applied when repairing the product. We will carry out a voluntary…
  571. d082c96a-7ef9-1327-5980-55967f71d7bf
  572. 03ce8e7d-0e72-af2c-b503-da32a8eb7705
  573. An investigation by an overseas manufacturer has confirmed that there is a possibility…
  574. 5c918eba-c524-1403-d465-212f5f87b0ae
  575. a2f2000c-f368-1c25-bf07-fea47e77eba2
  576. Urgent Field Safety Notice for Patientenliegenetze IRATHERM100M by Von Ardenne Institut…
  577. c1a0a6df-58b2-648f-1a42-5989ce3e77fe
  578. We have received a report from the manufacturer that a component (tube) that has not gone…
  579. We have confirmed a problem with the high-frequency surgical device ESG-410, where the…
  580. After receiving reports from medical institutions that the balloon was not fully expanded…
  581. When using the AF-SGW circuit at a medical institution, the vendor advised that the…
  582. As a result of a survey conducted by overseas manufacturers, all Trilogy Evo series models…
  583. 7f544b69-4282-5357-ba42-745ac373ab02
  584. accfad6f-9303-37d9-9fba-536c9be6fdff
  585. 66e223d5-d1a8-ac5c-5b60-dfb145f6dea5
  586. 62f8b4dc-ce3b-9769-5eb9-6ddeff0bd74b
  587. ac777626-3f6d-2b77-0351-019f74567825
  588. Damage (holes) were found in the sterilized packaging of the IvyA1 separators and IvyA1…
  589. An overseas manufacturer sells "Capio Capturing Device (Capio Slim)" (hereinafter referred…
  590. We have received a report from a medical institution that the effective length of the…
  591. 427f45c5-ffaf-c150-505a-cc94084806f8
  592. DC250|DC350|DC750
  593. This product is a two-paste type resin cement for dental bonding, and the cement paste…
  594. 93695073-126c-0d6a-7279-791ef873c3c9
  595. e7eec5dc-3344-2547-c3ab-a830b3d81140
  596. Due to the occurrence of cracks in the parts (pump housing) incorporated in certain serial…
  597. When checking inventory, cracks in the casing and damage to the battery cover were found…
  598. b6ba3c91-5ce9-9d98-2f90-97eb4af54dfb
  599. Some of the ruby ​​laser goggles shipped as goggles for practitioners are shipped as Yag…
  600. Regarding the disposable silicone-reinforced tracheostomy tubes that we manufacture, we…
  601. At an overseas manufacturer, when using this device in HFO mode, the breathing circuit…
  602. 92c088db-d224-5b64-8182-cba6533accb0
  603. During the manufacturing process, damage (pinholes) were found in specific locations in…
  604. In the production area of ​​Bauerfeind AG, a foreign manufacturer, roofing work was…
  605. During inspection at the manufacturing facility of this product, fibrous foreign matter…
  606. We are currently manufacturing and selling the excimer laser system MEL80 (approval number…
  607. 1b706bdc-e5ca-701f-b447-e68218869e51
  608. For approximately two years from March 1, 2022 to March 8, 2024, the Centerra SmartPlus…
  609. 91458cc4-aab5-bc28-f26c-40565609eaea
  610. 78331539-7ff8-22ff-47b6-13793c179a40
  611. It has been reported that excessive inflation of the cuff of this product caused cuff…
  612. c5169478-2343-dd42-7ade-5f8d84f3c2f1
  613. Due to poor adhesion between the foot step of the product, which adsorbs to the…
  614. 1a4bb75b-2ff2-37db-b40c-f9f4c0c49ed1
  615. 08daa9aa-81ce-932c-a669-bd155738754f
  616. a69bf3dc-ce9b-111f-a153-082ded3a5f18
  617. fd5fa438-71aa-1074-982a-bcc6748eb524
  618. The circuit board coil and back plate mounting screws may come into contact with each…
  619. 1804839f-20f3-72c0-77d6-c01fab008516
  620. db1e778b-a30a-7939-358c-a6fddbbce3d8
  621. Based on the results of an investigation at an overseas manufacturer, some lots are…
  622. 5826d1fb-5448-305a-484e-89812823816a
  623. cfde3c93-6b7a-896f-3cc8-df5f60486a84
  624. Technical name: Anesthesia Kit
  625. Neaktivní implantabilní zdravotnické prostředky
  626. 2319ebb6-5335-b1f5-0d48-ef56e4412f25
  627. The retailer contacted us to inform us that due to a malfunction in the order entry…
  628. A customer reports a ``continuous negative pressure detection'' or ``not calibrated''…
  629. Urgent Field Safety Notice for LASERFASER Ø 272µM EINWEG by Richard Wolf GmbH
  630. Gravity Infusion Sets and Connectors (various)
  631. In cases of highly calcified lesions, MH Surgent Support Catheter (compatible guide wire…
  632. The safety parameter verification mechanism may be deactivated during some maintenance…
  633. The manufacturer has informed us about the operation of the collision detection system…
  634. d7130d56-131e-89a5-f417-84757c04f16a
  635. A medical institution recommends that the automatic peritoneal perfusion device APD device…
  636. A foreign manufacturer that is a consolidated subsidiary of our company stated, ``We have…
  637. 9831c974-6c46-c883-92d1-679c24567ca0
  638. 358b0e89-592f-f0da-b48c-4496683dd31f
  639. Recently, an overseas manufacturer has announced that the hook of the hook-and-loop…
  640. As a "glass thermometer," this product must be inspected based on the Measurement Act and…
  641. As a result of investigating defect reports received from the market at overseas…
  642. As a result of an investigation by overseas manufacturers, the products subject to this…
  643. 44e00929-6e70-c51f-4474-550c690a8288
  644. 2031c353-8144-8aa7-cff1-20cebe4cad0b
  645. During additional in-house software verification, we found that frequencies exceeding…
  646. dee5ad12-a8a4-d44e-e832-774f9ede709e
  647. The affected products will be recalled because they were manufactured and shipped during…
  648. 5c7843a4-a555-a90c-b1cb-c0b7df61994c
  649. As a result of research at overseas manufacturers, all Trilogy Evo series equipped with an…
  650. Daily disposable soft contact lenses “Focus Dailies” (product name: Dailies Aqua Comfort…
  651. 2f9edacc-a9c9-b5ce-dd1d-113e5c25ba45
  652. The certificate for this product (catalog number: EV12) stipulates a validity period of 1…
  653. 0df8ae8d-022e-e2d1-5344-0a1a0fa07ec3
  654. e0b28065-04ca-094b-7e3e-b54d7fdc54bb
  655. As a result of an investigation at an overseas manufacturer, temperature calibration…
  656. 05160a12-209a-c5af-5c95-2abd29091e67
  657. e76cf79b-3e1d-9dae-529b-eb77514aecc9
  658. As a result of an investigation by an overseas manufacturer, it was found that the sealing…
  659. 10d57892-6825-ef07-d08b-3d8cebfca11c
  660. b8946e28-86ba-cdb9-9ecd-b81816664826
  661. Although it is a product for a standard neck, there is a possibility that a product for a…
  662. a8e807ac-5fe6-bf16-85dc-87926a684b84
  663. We have received a report from an overseas manufacturer that there may be small holes in…
  664. 7347041b-4e2e-c65e-aea7-6058c4efbc4e
  665. We received a complaint about the affected lot and conducted an investigation, which…
  666. 264b7de0-cb55-81c0-d391-ae0206b7efc9
  667. During surgical procedures in which this device is used, complications due to excessive…
  668. Although this product requires approval as a Class II controlled medical device, the…
  669. de254154-9efd-b0ba-e97f-e7277f26bf14
  670. 63e66439-1a32-cb55-c000-990dfcfd53bf
  671. 057ceee5-7164-50d6-b47f-11afbc0d6da6
  672. The foreign manufacturer Kirchner & Wilhelm GmbH+Co. KG has provided blade base shapes for…
  673. According to information from the manufacturer, there may be small dents or cuts in the…
  674. In versions 1.3.0 and 1.3.2 of the target product's software "StealthStation S8…
  675. We have received a report from an overseas manufacturer that there may be small holes in…
  676. 0a240ab3-3e5d-c819-5c79-5789638a1ba3
  677. 26ffd267-d3af-265f-83cf-01b98f3d5424
  678. a70bc06b-c61a-aaef-6c40-f695817509fe
  679. A report from a medical institution revealed that product number SPO6 (0.6 mm in diameter)…
  680. ed65d8bd-690b-8d91-3ba8-d4d523e6abd2
  681. In our company's sales name "Parapack Plus", when the operation mode is switched to…
  682. 5a2ebed5-7144-c546-a769-d9fc1c6cf6a6
  683. We have received reports of defects in some products from medical institutions that supply…
  684. The general name of these products is non-active contact acupuncture, but the purpose of…
  685. An internal investigation revealed that the package insert for the product contained…
  686. A medical institution released M069A-070-24503L (Lot.2306390) from a sterile package…
  687. 640e92a4-1782-5657-5e40-84dd6f9e2b06
  688. This product is a single-use surgical instrument that attaches to a drill via a hub, and…
  689. 7fb67007-81f5-000e-55c4-c35cb8b72d54
  690. 742460aa-efe0-627a-0d8b-b6124ba68f5d
  691. Medtronic Percept RC and Medtronic Inceptiv wireless recharger (hereinafter referred to as…
  692. For this lot, we received a report that part of the anti-slip sole (heel) was missing…
  693. This product is used by attaching it to the brooch handle, but the dimensions of the…
  694. 830d3e7b-3f3f-6c3f-9aa7-c846bd7129a0
  695. Patient Support
  696. 8914d9d1-a71a-d1a4-4ccb-8048a866a6c8
  697. Alinity m System
  698. Pinnacle Radiation Treatment Planning System
  699. Lasertube (Rubber) Laser resistant tracheal tube, cuffed; Endotracheal tube for laser…
  700. EVIS X1 Gastrointestinal Videoscope
  701. RaySearch Laboratories AB RayStation - SSD võib harvadel juhtudel olla liiga kõrge
  702. CONTRAST MEDIUM, RADIOGRAPHIC, INJECTABLE Bottle, Medication
  703. Zdravotnické prostředky pro diagnostiku a terapii zářením
  704. Technical name: BALLOON CATHETER FOR PERIPHERAL ANGIOPLASTY
  705. Zdravotnické prostředky pro diagnostiku a terapii zářením
  706. 8e60f03d-e8b7-162c-d299-4cef3e9894ea
  707. During a performance test of our product, incorrect color correction data was programmed…
  708. When an overseas manufacturer conducted a verification test on the inflation pressure of…
  709. 5126b37f-2e50-8042-a3be-b027c7843aab
  710. 8a09cf3c-8808-9d0b-3e47-f05de0e94b40
  711. 4df11553-fa42-701b-15e3-784652cecca2
  712. After checking the manufacturing process of this product, we found that the pins that make…
  713. 3705d542-af44-38cc-fdf7-cd8cfc2b4888
  714. 8000620b-6241-4a21-1763-33f44f6c7752
  715. The tracheostomy tube included in the percutaneous tracheostomy kit that we manufacture…
  716. Regarding the BLU tracheostomy tube that we manufacture and sell, in a specific lot of…
  717. We are pleased to inform you that the label of a particular lot of Cook Approach Hydro ST…
  718. 30e13f68-4800-de8f-d7c8-843dc9b3fcf0
  719. Some products of the endoscopic water pump OFP-2 (hereinafter referred to as the…
  720. 23acb44f-7b2c-3eda-8d61-bbcc7098df69
  721. It has been confirmed that the pump is working but cannot draw suction. We will implement…
  722. 0e124403-1274-9464-9701-1afc60c347ca
  723. 1c50ccbc-e770-1805-4b71-89cd60b8db15
  724. As a result of an investigation at an overseas manufacturer, the residual endotoxin level…
  725. f9e9fc62-9711-6e30-275a-d4275a98c44c
  726. b7e16ac9-ab81-223c-54d7-26fbcd21dad2
  727. We received a report from the market that there was a white foreign substance attached to…
  728. An overseas manufacturer confirmed an error in the manufacturing process of measuring…
  729. 112aa20f-46a2-d926-7d51-0739c34abc7a
  730. This product uses compressed air sent from a dental treatment unit to spray abrasives…
  731. 3a7b3715-5638-8ca1-fa1b-c11f923b36e6
  732. 353699ab-ae03-6b11-8872-d797781526c7
  733. Products manufactured at a registered manufacturing facility that performs the main…
  734. d7ab3fe7-7a8b-af52-3af9-65619f21f0c9
  735. 83898d98-d94a-3d2a-75de-25113b8c82d3
  736. acd4842c-f625-eea1-d9b3-414c4c88372c
  737. It has been discovered that there is an error in the hydraulic piping of this product…
  738. e38edf7c-4004-1105-e647-190235c2e3e0
  739. In selected lots from the worldwide market, the Luer connection of the 20/30 inflator…
  740. 28aa09b6-dfb3-2abc-e655-25272fe0c964
  741. a8fa61d3-0292-c95c-c64f-05a4ca604e49
  742. Due to a defect in the manufacturing process of a foreign manufacturer, the heat treatment…
  743. A report from our subcontractor revealed that the circuit board contained components that…
  744. b5dfbfce-498c-5f82-25b3-e64fa8a98eeb
  745. For neonatal flow sensors with a specific serial number, an overseas manufacturer has…
  746. Regarding the product manufactured and sold by our company, in a foreign country, the…
  747. 9f7b2e15-fbec-dba5-1bfb-0dc507c6a12c
  748. bb380801-af73-4ac5-6fcc-a0e8076dd5ab
  749. b75c5193-24f7-b7dc-5bf7-fbff2683503a
  750. Due to forgetting to renew the registration of the main assembly factory for this product…
  751. 4d7227ff-7a52-857f-3901-b92cf9492df8
  752. b678e153-b15d-0e02-f1bb-6be9f0459c5f
  753. 3f9a9912-aac5-954a-f124-7232997e8a4b
  754. d816046f-5f9b-3127-4ad3-1594f4bd5c8a
  755. Regarding the product manufactured and sold by our company, in a foreign country, the…
  756. In this product, a product whose cell line width (strut width) of the stent deviates from…
  757. The screws of the accessory ``tonometer base TB700'' that fixes the slit lamp that is…
  758. Technical name: Instrument for Laparoscopy
  759. f11a6e7e-759d-2b2b-5c43-8543e2e57114
  760. c729e68b-c79a-0867-de41-e4383d4cba57
  761. We have received complaints that it is difficult to see when wearing lenses with products…
  762. We received reports from two domestic distributors that there were errors in the product…
  763. It has been discovered that products sterilized at a manufacturing facility other than the…
  764. 0.014 In some products of PTA balloon catheter (OTW type), the outer catheter may be…
  765. It has been confirmed that the shape of the pin in a specific lot of the target product…
  766. 2dda885f-94ed-b3f7-a785-65be0445d183
  767. We have received a report of an incident where the needle storage part was damaged during…
  768. A domestic medical institution reported that when the product was disconnected from the…
  769. We are currently manufacturing and selling a single-use ophthalmological knife nuclear…
  770. We are currently manufacturing and selling ophthalmic surgery laser lens treatment pack…
  771. We have confirmed an increase in complaints regarding BML-V442QR-30. It was discovered…
  772. This product can be used to connect to a syringe or medicine container to inject into the…
  773. During testing of this product, the overseas manufacturer became aware that the internal…
  774. c35610e0-e176-20d0-2054-65230ee82cc9
  775. 6c731d7f-9307-857d-cf62-093447baca2a
  776. We received one quality report from a medical institution in which the power went out and…
  777. d5e071a9-629d-502d-fd87-da96631d49ba
  778. "Ophthalmic needle Nipro disposable" manufactured by Nipro Co., Ltd., which is included in…
  779. At an overseas manufacturer, when using a specific lot of this product, the endoscope…
  780. 0004ee23-6229-4ef0-3169-c04544a4580c
  781. 19c0212b-d940-70e1-0dd6-c6a270b957d9
  782. Regarding the "Nipro disposable intraocular injection needle" (medical device), which is a…
  783. Parts to hold the osseoshaper in place included with the N1 implant (Material 85576, NS P…
  784. Medical institutions have complained that the device restarts automatically during use. We…
  785. 682c275f-8228-afaf-104a-d9de5627a5ef
  786. Because the manufacturing industry registration of the design and manufacturing facility…
  787. The manufacturing site (design, main assembly) listed on the standard conformity…
  788. 9f5b866a-b250-b00e-4492-2e5b85c6ed48
  789. The product is a sterilized product with the following two types of effective lengths, but…
  790. Urgent Field Safety Notice for AQT90 FLEX Analyzer by Radiometer Medical ApS
  791. A product without legal labeling was shipped, so we will recall the product.
  792. 33ed1822-d186-0577-9995-14c09c389e9b
  793. The manufacturer has informed us that due to a manufacturing issue, the device has a lower…
  794. The product consists of a main body, a cylinder, and a screw, and the screw is inserted…
  795. The screws (bolts) that are the components of the pump inside the Neptune 3 Rover, which…
  796. 97eb7e90-f09f-561d-8e17-61a287053faa
  797. 7a084df9-1810-91a3-1eeb-236ccc6eae40
  798. 728d1672-9a69-b3e5-fef5-b2e879f5608c
  799. 30eb5b8a-9e8a-8fa3-5aed-1e4e4625cd9b
  800. 4c8ecef5-a43d-d335-5d05-e9f8d2bffdf1
  801. For the two of the lots of the target lots in the target product name and part number, the…
  802. As a result of an investigation of overseas manufacturers, the sealing of the sterile…
  803. In the name of our sales name "Parapack Plus", the ventilation connector of the patient…
  804. We manufacture and sell PORTEX/Nasal Airway, Catheter Mount, PORTEX/Thermovent. In the…
  805. In the trachea tube intrudusa that we manufacture and sell, we will contact you from the…
  806. We received a message from the user that the spring in the grip broke. We are voluntarily…
  807. The wrong brand name and notification number were written on the display label for…
  808. Among the "Single-time joint surgical surgical instruments" composition, AR-8916-06 is…
  809. For this product, if the exterior (handle part) of the main unit has cracked, etc., it can…
  810. b5dfa403-94fa-311f-2774-2d833d153d19
  811. 86a40e02-eab9-2229-cfb7-32b1c88edaef
  812. ea369126-95f2-0e13-5e5a-5aa700e1101c
  813. d44d2c4e-5f26-239e-54e8-3664f4614783
  814. be7d6ee9-aa67-1e37-c492-ae0cf2e1cc04
  815. 74be8967-fc51-2281-1ae3-b4830b599f10
  816. 76f5794b-233c-4653-7a22-564d0acfc406
  817. f54eb919-ece4-3c50-6c87-f344be3884a6
  818. dc37edfd-f131-9f41-9946-ad86832ed98f
  819. b51967e0-1466-9b11-315c-cfd844d2b007
  820. 9fa7169a-75f4-5251-aafb-809fbfba72b4
  821. 7e013cc8-51ef-29b8-469c-c257a59647ce
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  828. 26aa1625-ec3a-f0fb-e02b-138bd68eec8f
  829. 7841f567-c801-b48b-5f6c-6e71e7c49949
  830. Technical name: Nuclisens EasyMAG Magnetic Silica
  831. Diagnostické zdravotnické prostředky in vitro
  832. 47a0e8c3-ed4f-7699-2c5a-dd0177707cf3
  833. 897aa67e-735f-7f8d-8e3e-e94f23564d7c
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  894. eb014360-8e27-8fa0-54eb-56501e07e1fd
  895. Nome comercial: Cateter Ultraflow/Marathon Flow Directed Micro Cateter
  896. 522218be-797c-1a45-7365-37d23083b5a9
  897. 6b0721dd-34fb-456f-bc4d-95e5ba236d4e
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  906. c8908313-4df0-07cc-e9a7-e3259cf12671
  907. 82f61dcb-0694-f4f9-c28b-5f5866657d42
  908. Urgent Field Safety Notice for Atellica IM 1300/1600 and CH 930 Analyzers by Siemens…
  909. e83ffb6a-0859-fe56-a5c7-0e06b71ba521
  910. a2a13917-f93c-aff1-f0de-7c28832ca244
  911. e1a83286-1208-206d-e5ba-45b7899fc4bd
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  931. 4c876240-d33a-58c3-9e20-c8d5ccd36dab
  932. 39e80857-bc77-c39d-d02a-e15b27a8576c
  933. Urgent Field Safety Notice for Atellica COAG 360 System by Siemens Healthcare Diagnostics…
  934. 451871d3-4283-281d-bf73-0188da4a4ef6
  935. 0a1291e8-80d6-3e91-034c-4493af638947
  936. b9b4d25b-7360-44b5-1777-8b6c098188ed
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  943. f4bd0cfd-a73d-1c46-34d8-24617b75ae1c
  944. 8eadcce4-7bde-db14-9231-9535ac5c98f6
  945. 7fa9dd4f-bb65-a71f-c134-22aeb4eae12a
  946. 5b0933f1-4152-1a13-ea9f-508f2ad75996
  947. 0efae29b-d26c-e9cd-73e5-e5ea10297e5a
  948. edbf8d2e-e66e-906f-1810-8d446648686c
  949. 154cc297-0622-51f7-f584-aeb44b3ea671
  950. 68a9bafd-059d-5d06-67de-dc6cf5d208de
  951. 5d41083b-eec8-7f3b-1067-ff13f2d0a57b
  952. 6e7c6c6c-3482-0979-1df7-ab99db352d95
  953. c2151e02-2213-8cc8-ed77-f6fb1606fac3
  954. 2a58c583-40c0-da9e-b6a8-4b2416d72488
  955. 84f7998d-8edc-981c-e914-7f380d327dc0
  956. 5fe6a1e3-1665-f56e-9ded-56ef20013a1f
  957. 6c003ddc-135f-2716-8f98-b817a813d4c6
  958. d206ea0c-b592-9d41-8a99-7f80a5371672
  959. 98fdd837-8bbc-c9d4-ee6a-2bc6ae829e3c
  960. 1a727777-cf18-4daa-562e-3c96a06c4a92
  961. 0b08c7c0-d60f-196b-fcb6-70ec190efabe
  962. 7002e930-2a6f-3741-d6bc-58421998c350
  963. 18b0c189-d990-3257-9002-626ec1868d19
  964. fec06986-a5dd-27f3-4a56-754c2275755e
  965. ba816903-cc61-daf4-d1b9-39afde73a770
  966. c9962ecc-5f85-d63a-1ba1-1d81d705ccb2
  967. 0aa1a6c5-e4da-8b44-bea5-0e0b82757d16
  968. a7336e42-3d63-914d-9c45-13e99c864030
  969. b4aa5d60-bcab-8e60-2500-7f04e5d8d3f3
  970. e976b2ee-009b-2e60-e32c-8350756b4dea
  971. fb4920d8-24d7-6442-2b3e-bdadb9da5e76
  972. 7c5e03e7-97e1-abea-4e70-2d3de6aec287
  973. 24baa6c6-daa2-5910-593b-daa2db9aaf2d
  974. 967ade21-2b1f-87f9-f194-4be5ec57a19a
  975. 10e16ffa-4342-b276-5c12-39c179d55eb2
  976. Technical name: LEKTRAFUSE HF GENERATOR BIPOLAR
  977. 89842c44-0b64-f043-99b2-d7eb5f9ed2ec
  978. 2cc96d5a-86bf-1c6c-a86d-57c87d021597
  979. e01f2bc7-556a-e754-cbb1-f77e69fd5681
  980. 3a38c7bf-398f-084a-19fa-69795d5b9a1e
  981. Urgent Field Safety Notice for A-CP Kits Family, RegenKit-BCT Family by Regen Lab SA
  982. 9e17300e-600c-9b44-0f51-3ec35d792f4f

About this dataset

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1