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International device safety notices

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

  1. Corrective action for Mueller Hinton 2 Agar, bioMérieux
  2. Urgent Field Safety Notice for DiaClon Anti-M/N by DiaMed GmbH
  3. Information for STERRAD Sterilizer, Ethicon
  4. Batch recall for Agilia Volumat Set VL ON 70 and VL ON 72, Fresenius Kabi
  5. Recall for the Perfectum Tuberculin Glass Syringe & Micro-Mate Tuberculin Glass Syringe…
  6. Recall for Das gesunde Plus Hals & Rachenspray, Deutpharm
  7. Urgent Medical Device Safety Notification for the CODMAN® CERTAS™ Programmable Valves…
  8. Urgent Field Safety Notice for LEGION CR HIGH FLEX XLPE by Smith & Nephew, Inc.,
  9. Urgent Field Safety Notice for COMPELLA SCALE RENTAL by Hill-Rom Company, Inc.
  10. Recall of unused power cables made by the company UNICABLE, Zeiss
  11. Urgent Safety Notice for the Samsung LABGEOPT Lipid Test 5S and LABGEOPT Lipid Test 5…
  12. Corrective action for the Relax wall mounted shower seat, Etac Supply Center AB
  13. Urgent Field Safety Notice for ZNN and MDN Guide Wires by Zimmer Inc.
  14. Safety Notice for aycan workstation OsiriX Pro, Aycan
  15. Field Safety Notification for Reamer / Irrigator / Aspirator-System (RIA), DePuy Synthes
  16. Safety Notice for MD-JADE 2 Software, MeVis Medical Solutions
  17. Urgent Safety Notice concerning AVEA ventilators, CareFusion
  18. Safety Notice for i-CAT Classic, Imaging Sciences International
  19. Safety Notice for body-jet und harvest-jet liposuction systems, Human Med
  20. Urgent Field Safety Notice for Venture by Vascular Solutions, Inc.
  21. Chargenrückruf von Zenostar MT Color und Zenostar MT Color Impulse, Wieland Dental +…
  22. Urgent Safety Notice for the E.CAM® Patient Handling System (PHS), Siemens
  23. Urgent Field Safety Notice for Applied Biosystems COVID-19 Interpretive Software by Life…
  24. Safety Notice for the device GE Centricity™ PACS-IW, GE Healthcare
  25. Safety Information for the Cemover device, Tecres S.p.A.
  26. Recall for the PiCCO catheter, PULSION Medical Systems SE
  27. Recall for Protégé® EverFlex Biliary Stent System, Ev3
  28. Safety Notice regarding Dash 3000/4000/5000 monitors, GE Healthcare
  29. Urgent Field Safety Notice for recomWell Campylobacter IgG by Mikrogen GmbH
  30. Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland…
  31. Safety Notice for Advantage Workstation with Functool Option, GE Healthcare
  32. HeartStart FR3
  33. Field Safety Notice concerning safety issue because of an unintended rotation of the…
  34. Urgent Field Safety Notice for FRED easyport plus by Schiller AG
  35. Recalls several lotnumbers of AxSOS Screwdrivers from manufacturer Stryker Trauma AG from…
  36. Corrective action of Beckman Coulter for UniCel peristaltic pumps
  37. Recall from BioMerieux for Vitek 2 GN identification cards
  38. Recall for Lumen™ Xtract Aspiration Catheters, Volcano Corporation
  39. Urgent Field Safety Notice for WiSE CRT Transmitter by EBR Systems, INC
  40. Battery Recall, Akkuplanet
  41. Information for Primedic DefiMonitor XD range, Metrax
  42. Safety Notice for Synchromed II Implantable Drug Infusion Pumps, Medtronic
  43. Corrective Action for Nanostim Leadless Pacemaker & Delivery System Catheter, St. Jude…
  44. Urgent Field Safety Notice for AbViser AutoValve Pressure Monitoring Device by ConvaTec…
  45. Recall for Oximetry-PODs model 7600B. Nonin
  46. Urgent field safety notice for chromID MRSA SMART (Ref. 413050-413051), bioMérieux SA
  47. Information for the HM355S / HM340E Rotary Microtome, Thermo Fisher Scientific
  48. Urgent Field Safety Notice for Thoracic Catheter 16F Angled Soft, Adult Connector by…
  49. Urgent Field Safety Notice for NextSeq 550Dx by Illumina, Inc.
  50. 2aeab7b7-60d0-d818-6ec6-afee9a933660
  51. Recall for MKONA-Z and MKONA-1, Privates Institut für Immunologie und Molekulargenetik
  52. Corrective action for ETI dsDNA, Dr. Fenning Biomed
  53. Corrective action for COBAS INTEGRA 400/400 plus systems, Roche
  54. Lot recall of application devices by SFM Medical Devices GmbH, Octapaharma
  55. Corrective action for the da Vinci® Xi™ Surgical System Draping, Intuitive Surgical
  56. Lot recall for Flexible Shaft Ø 8.0 mm / L 360 mm for extraction system for solid…
  57. Corrective action for the Clinical Chemistry ICT Serum Calibrator, Abbott
  58. Urgent Field Safety Notice for CORFLO* PEG Kit with ENFit Connector by Avanos Medical Inc
  59. Recall for CHOOSTENT and HANAROSTENT, MTW
  60. Urgent field safety notice for disposable fiber optic blade Miller type (single packages)…
  61. Urgent Field Safety Notice for Alere TESTPACK + Plus STREP A with OBC by Alere Medical…
  62. Safety Notice for Innova 2121IQ and 3131IQ cardiovascular X-ray systems, GE Healthcare
  63. Corrective action and recall for m2000rt, Abbott
  64. Lot Recall for ELISA test Imtec CIC IgG, Human Gesellschaft für Biochemica und Diagnostica…
  65. Corrective action for the Beacon Tip Angiographic Catheters, Cook Incorporated
  66. Urgent field safety notice for AVEA Ventilator, CareFusion Corporation
  67. Safety Notice for Blizzard active wheelchair, Otto Bock
  68. Corrective action for the Dimension® EXL™ Integrated Chemistry Systems, Siemens Healthcare…
  69. Information for HomeChoice and HomeChoice Pro, Baxter
  70. Safety Information regarding different Celsite port systems, B.Braun Medical S.A.S.
  71. Urgent Field Safety Notice for FlexLab by Inpeco SA
  72. Recall for Martel Printer, Abbott
  73. Corrective Action for Running UniCel Dxl System Software versions 4.2 or 4.2.1, Beckman…
  74. Recall of bag systems, Gambro
  75. Urgent Safety Notice for VITROS® Immunodiagnostic Products CA19-9 Calibrators and Reagent…
  76. Lot recall of Ebb Complete Tamponade System (CTS-1000), Clinical Innovations LLC
  77. Safety Notice for SERVO Ventilator 300 and SERVO Ventilator 900, Maquet
  78. Field Safety Notice for Autoclave from manufacturer Dental X
  79. Recall for intrauterine probes (tubes) with lot numbers up to and including lot J13…
  80. Corrective Action for Bar Code Scanner, Abbott
  81. Corrective action of Roche Diagnostics Ltd. for Cobas c111
  82. Urgent Safety Notice for the JenaValve prosthesis, JenaValve Technology GmbH
  83. Information for Cardiolab/Mac-Lab/ComboLab IT, GE Healthcare
  84. Recall of urethral catheters from manufacturer Coloplast
  85. Lot-Recall for Medfusion Syringe Infusion Pumps Models 3010A and 3500, Smiths Medical…
  86. Recall of Xeno III Extra Drops Refill from Dentsply DeTrey
  87. Urgent Safety Notice for VITROS® Chemistry Products DT Calibrator Kit 44, Ortho Clinical…
  88. Urgent Field Safety Notice for UNIVERSAL TWINBAR 670 by Liko AB
  89. Recall for Anti-Co(b), Immucor
  90. Recall for OTSC System Set, Ovesco Endoscopy AG
  91. Safety Notice for the NeuViz 16, Neusoft Medical
  92. Corrective action for the Guardian® REAL-Time Monitors, Medtronic
  93. Urgent Safety Notice for the Cholesterol FS, Creatinine PAP FS and for the other tests…
  94. Urgent Field Safety Notice for GM85 by Samsung Electronics Co. Limited
  95. Urgent Field Safety Notice for Aptio Automation by Inpeco SA
  96. Lot Recall for NexGen Femoral Component, Zimmer
  97. Urgent Field Safety Notice for HISTOACRYL BLUE/ LAPFIX/PROSET OFX by B. Braun Surgical…
  98. Recall for Cutting Burs and Irrigation Clips packaged in a Tyvek pouch/Tube configuration…
  99. Recall for ELISIO H, Nipro Europe N.V.
  100. Urgent Field Safety Notice for Accelerator a3600 by Inpeco SA
  101. Safety Notice for Chromophare surgical lights and Chromoview camera, monitor and appliance…
  102. Urgent Safety Information for the PEGASUS 3-D-System, BfMC Biofeedback Motor Control GmbH
  103. AUTOMATED HEMATOLOGY ANALYZER XP-300
  104. Mallinckrodt Pharmaceuticals INOmax DSir varustussüsteem - seade ei ühildu Leoni Plus…
  105. Durapore Advanced Surgical Tape
  106. Corrective action for CRP LX and CRP HS to cobas 6000<cc> und cobas 6000<cce>, Roche
  107. Corrective action for the Recipient Vacuum Trephine, Network Medical Products
  108. Urgent Field Safety Notice for Leica M525 by Leica Microsystems (Schweiz) AG
  109. Safety Notice for the Biolox® OPTION Ceramic Femoral Head System, Zimmer
  110. Urgent Field Safety Notice for M.Scio by Christoph Miethke GmbH & Co. KG
  111. Lot Recall for NanoCross 14 OTW PTA Dilatation Catheter, Ev3
  112. Urgent Field Safety Notice for Sciatic Nerve Retractor by Synthes GmbH
  113. Exchange of actuators manufactured by Linak in care beds, Betten Malsch GmbH
  114. Lot recall of Anatomical Shoulder 2.0 Dome Centric, Zimmer Biomet
  115. Lot Recall for Reperfusion Catheter 032, Penumbra
  116. Recall of Flexible Probe with Blocking Washer, Varian medical systems
  117. Lot recall of various sterile-packaged hip and trauma implant screws, Zimmer Biomet
  118. Lot Recall for handles, Rolko Kohlgrüber GmbH
  119. Recall of the der Resolve Biliary Drainage Catheters from Merit Medical Systems
  120. Field Safety Notice concerning a corrective action of the digital neurophysiological…
  121. Lot Recall for Guttapercha and RealSeal Cartridge Kits, SYBRONENDO
  122. New reprocessing instructions for "HITACHI Ultraschall - Rektalsonden" (ultrasound…
  123. Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
  124. Urgent field safety notice for FIRMap Catheter, Topera GmbH / Abbott Electrophysiology
  125. Recall of lots of Saber 30 with Integrated Cable Wand from ArthroCare
  126. Corrective action for Galileo Echo, Immucor
  127. Advisory Notice for O-ARM® Intraoperative Imaging Systems, Medtronic
  128. Corrective action (Additional Cleaning Procedure) for the EVIS EXERA II DUODENOVIDEOSCOPE…
  129. Lot recall of core hole drill midi Ø=3.3 mm AO and core hole drill maxi/FFS/PFS Ø=4.3 mm…
  130. Urgent Field Safety Notice for Adapter for handpiece, guided reusable, for guide by…
  131. Urgent field safety notice for ProteusPLUS, IBA
  132. Information for Bravo® pH Capsule, Medtronic
  133. Recall of MANI Trocar Kit, MANI, Inc.
  134. Urgent Field Safety Notice for Trinity Acetabular Hip System by Corin Medical Ltd.
  135. Field Safety Notice of multiplane Transesophageal Transducer
  136. Corrective action / Recall of several batches of SURESHOT Humeral 3.2 MM AO Drills, Smith…
  137. Recall of laryngeal masks, Besmed
  138. Urgent Field Safety Notice for RetCam Envision Lens by Natus Medical Incorporated…
  139. Safety Notice with important additional reprocessing instructions, Stryker
  140. Urgent Field Safety Notice for LumiraDX SARS-CoV-2 Ag Test by LumiraDx UK Ltd
  141. Field Safety Notice for the ACIST Angiographic Injection System
  142. Corrective action for Advia 120/2120/2120i Hematology Systems, Siemens
  143. Safety Notice for Amsco® V-Pro™1 and V-Pro™1 Plus Low Temperature Sterilization Systems…
  144. BIOPHEN PROTEIN C LRT
  145. Urgent Safety Notice for the 1.5T SENSE Body Coils used with ACS-NT, Intera 1.5T and…
  146. Safety Notice for Medtronic CryoCath Arctic Front System, Medtronic CryoCath LP
  147. Recall ultrasound transducer, B-K Medical
  148. Recall for ERAGON and POWERGRIP Forceps, Richard Wolf GmbH
  149. Lot Recall of the Trabecular Metal™ Acetabular System Shell without holes, Zimmer
  150. Urgent field safety notice for DigitalDiagnost 4.0.4 / 4.1.2 / 4.1.3, Philips Medical…
  151. Recall of Complement Reagents (OWZD11), Dade Behring
  152. Recall of Male Swab, Roche
  153. Lot Recall for Pressure Infusion Cuffs, Welch Allyn
  154. Urgent field safety notice for MSK 1.5T Extreme and Optima MR430s Cryogen Vent, GE…
  155. Urgent Field Safety Notice for Infect/Cardio CRP by concile GmbH
  156. Recall of and Important Field Safety Notice on Synergy Micro-pump system implantable…
  157. Urgent field safety notice for Vancomycin (ONLINE TDM Vancomycin / HITACHI VANCOMYCIN)…
  158. Urgent Field Safety Notice for GreenLight MoXy Fiber Optic by American Medical Systems…
  159. Recall of certain lots of Magic3™ Hydrophilic-coated Female Intermittent Catheter…
  160. Urgent Field Safety Notice for Medumat Transport by WEINMANN Emergency Medical Technology…
  161. Field safety notice of MultiDiagnost Eleva X-ray systems from Philips Healthcare
  162. Urgent Field Safety Notice for LOQTEQ divers by aap Implantate AG
  163. Urgent Field Safety Notice for TACTYS - IPP Prosthesis -Proximal Surface by Stryker Trauma…
  164. Corrective action for the Allura Xper system, Philips Healthcare
  165. Unomedical Ltd. has issued a Field Safety Notice concerning a recall of the ECG electrodes…
  166. Information for DigitalDiagnost, BuckyDiagnost, EasyDiagnost und Thoravision systems…
  167. Recall for the AdVance® XP Male Sling System, American Medical Systems (AMS)
  168. Information for PACS System EasyVision RAD Release 4.2 V2, Philips
  169. Urgent Field Safety Notice for Kangaroo Enteral Feeding No.-Sterile Pump Sets by Covidien…
  170. Information for DigitalDiagnost X-Ray Systems, Philips
  171. Safety Notice concerning certain software versions of FDR AcSelerate X-ray system…
  172. Information for DigitalDiagnost, Philips
  173. Safety Notice for Brainlab iPlan RT Dose Radiotherapy Treatment Planning Software…
  174. Information for Diagnost and integris X-Ray Systems, Philips
  175. Recall of EnVeo™ R Loading Systems, Medtronic CoreValve LLC
  176. Urgent Field Safety Notice for VivaDiag COVID-19 lgM/ IgG Rapid Test by VivaChek…
  177. Safety Notice for e.cam SPECT camera systems, Siemens
  178. Safety Notice for Powerheart, Cardio Vive and Responder Defibrillators, Cardiac Science
  179. Recall for MKMTR 1, Privates Institut für Immunologie und Molekulargenetik
  180. Recall for the product Oxoid MacConkey Agar No. 3, Thermo Fisher Scientific
  181. Urgent Field Safety Notice for EEA Hemorrhoid and Prolapse Stapler Set with DST Series…
  182. Field Safety Notice concerning X-ray systems from Philips Healthcare
  183. Safety Notice for IntelliVue Information Center, Philips
  184. Safety Notice for Philips Intellivue Clinical Information Portfolio, Philips
  185. Urgent Field Safety Notice for Guider Softip XF Guide Catheter by Boston Scientific…
  186. Urgent Safety Notice for the Sicuro pesa hospital bed, Joh. Stiegelmeyer GmbH & Co. KG
  187. Safety Notice for the Trinder reagents (package inserts for the products will be updated)…
  188. Urgent field safety notice for MX 16-slice computed tomography x-ray system, Philips…
  189. Safety Notice for the Accent DR dual-chamber pacemaker and the Anthem CRT-P, St. Jude…
  190. Recall of OXOID Deutschland / Thermo Fisher Scientific for Horse Serum
  191. Safety Notice for the Birdie and Flamingo patient hoists, Invacare
  192. Recall for the Strep-A-Rapid Test Device, Innovacon
  193. Safety Notice for PK7300 Blood Grouping System, Beckmann Coulter
  194. Recall of Singleday Infusor, Baxter
  195. Field Safety Notice about missing Warning Messages in the Release Note from Varian Medical…
  196. Recall for Perthese Sensitive B540 Breast Implants, Mentor Medical Systems
  197. Recall Vascuflex SEC, B. Braun
  198. Corrective Action for ADVIA Centaur and ACS:180 Systems, Siemens
  199. Recall for PANTA support device, Newdeal
  200. Corrective Action/Recall for INNOTEST hTAU, Innogenetics
  201. Recall of the suture Monosyn undyed USP 3/0 with DSMP19 needle, B. Braun Surgical SA
  202. Recall of Triathlon Inserts, Stryker® Orthopaedics
  203. Recall for the Gazin® Balls 2+3 and Gazin® Balls 2+2, Lohmann & Rauscher GmbH & Co. KG
  204. Recall for the Modular Knee Joint, Otto Bock HealthCare GmbH
  205. Recall for BO1070S Bolton-Broth, Oxoid
  206. Corrective Action of Beckman Coulter for Power Processor with LX Connections
  207. Safety Notice for the Philips Xcelera Connect R2.1L1 SP2, Philips Healthcare
  208. Safety Notice for ProMap Catheter, ProRhythm Inc.
  209. Corrective Action for Galileo Echo, Immucor
  210. Corrective Action for IMMULITE / IMMULITE 1000 Third Generation TSH, IMMULITE 2000 Rapid…
  211. Safety Information for the Aviator drill, Stryker Spine
  212. Information for Philips IntelliVue Patient Monitors, Philips
  213. Urgent field safety notice for DuraDiagnost X-ray system with software version 3.0.3…
  214. Recall Columbus Tibia Hemi Spacers, B. Braun Aesculap
  215. Urgent Field Safety Notice for 1000 ml Canister (with Gel) for InfoV.A.C.® and V.A.C.ULTAT…
  216. Corrective action for the IBC Aortic Punch products, International Biophysics Corporation
  217. Urgent field safety notice for DuraDiagnost X-ray system with software version 4.0.2 /…
  218. Urgent Safety Notice for the Equinoxe Shoulder System, Exactech, Inc.
  219. Safety Notice for Diamond-TwinS diamond cutters, Karl Storz GmbH & Co. KG
  220. Recall for i-STAT 1 Analyzer, i-STAT Portable Clinical Analyzer, i-STAT 1 Abaxis Analyzer…
  221. Urgent field safety notice for Dimension Vista Enzyme 2 Calibrator / Dimension Enzyme II…
  222. Field Safety Notice regarding possible failure of the brakes in beds
  223. Safety Notice for the Össur prosthetic feet with attached aluminum male adapter, Össur hf
  224. Recall for SOMNOcomfort 2, Weinmann
  225. Lot recall of Resolute Integrity Zotarolimus-Eluting Coronary Stent System, Medtronic
  226. Urgent Field Safety Notice for ADVIA Chemistry Systems Urea Nitrogen (UN) Reagent by…
  227. Safety Notice for VITROS Chemistry Products DGXN Slides, Ortho Clinical Diagnostics
  228. Urgent Field Safety Notice for Stratus CS 200 Acute Care Diagnostics System, Siemens…
  229. 1152da01-1fe9-28a3-97f4-6966cfcd41f7
  230. Urgent Field Safety Notice of the ICD EnTrust and EnTrustEscudo from Medtronic
  231. Recall of customer specific surgery sets, Imtegra OHG
  232. Corrective action for the products Genium, Genium X3, Otto Bock Healthcare Products GmbH
  233. Urgent field safety notice for Calix P Peek Lumbar System and Calix T Peek Lumbar System…
  234. Recall Pastorex™ Strep Test, Bio-Rad
  235. Recall of Cemento Fixx, OptiMed
  236. Safety Notice for Transport Pro Monitor, GE Healthcare
  237. Recall for the MembraneBlue® Dual Ophthalmic Surgical Liquid, distributed in Germany…
  238. Urgent Field Safety Notice for Segmental System Proximal Femoral Component 38mm by Zimmer…
  239. Safety Notice regarding Medumat Transport ventilators with CO2-module, Weinmann
  240. Urgent field safety notice for Lifepak 15, Physio-Control Inc.
  241. Safety Notice for PRIMEDIC™ AkuPak, Metrax GmbH
  242. Corrective action for the Allura XPER Systems, Philips Healthcare
  243. HOLDEX Single-Use Holder PP single-packed, steril
  244. ThermoScientific Oxoid Ceftazidime 256 M.I.C.E.
  245. Safety Notice for Medtronic Ablation Frontiers GENius Multi-Channel RF Generator…
  246. Urgent Field Safety Notice for Various Arrow Products by Arrow International Inc.
  247. Recall for Biotrak Mini Drill and Long Cannulated Drill, Acumed
  248. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
  249. Final Information concerning the OptonPro device for laser therapy, Zimmer MedizinSysteme…
  250. Recall for Berichrom PAI, Siemens
  251. Baxter HD Monitors - hoiatus konnektorite kasutamise kohta
  252. Advisory Notice for AK 95 and AK 95 S, Gambro
  253. Urgent Field Safety Notice for Ausfahrsicherung (Stryker M1-Trage) by Stryker…
  254. Lot Recall for the 13 Hole Scapula Medial Boarder Plate, ACUMED
  255. Safety Notice for VISALIS S500 and VISALIS V500, Carl Zeiss Meditec AG
  256. Field Safety Notice concerning External Sterilizable Defibrillation Hard Paddles used with…
  257. Safety Notice for Eclipse™ Client software versions with build numbers from 7.3.10 through…
  258. Recall for CBCII Blood Conservation System, Stryker
  259. Urgent Field Safety Notice for T5, T10-NT, ACSNT, Intera 0.5T/1.0T, 1.5T, Achieva by…
  260. Urgent Field Safety Notice for Origio Sperm Wash Medium by Cooper Surgical Inc.
  261. Software update of M3170 IntelliVue Patient Link, Philips
  262. Information for Brilliance 6, 10, 16, 16P, 40, 64, BigBore und MX8000Dual v. EXP, Philips
  263. Urgent Field Safety Notice for SonoFlex EBUS - Nitinol Nadel by Endo-Flex GmbH
  264. Corrective action for kombiTROLL 2000 and 3000, Trumpf Kreuzer Medizin Systeme
  265. Recall for Microzid sensitive wipes, Schülke & Mayr GmbH
  266. Recall of all lots of the product Suction Wand, Edwards Lifesciences
  267. Urgent Field Safety Notice for SonoTip EBUS Pro Flex by Medi-Globe GmbH
  268. Follow-up Safety Notice for AQUARUIS dialysis machine, Edwards Lifesciences
  269. Urgent Field Safety Notice for ExacTrac Dynamic by Brainlab AG
  270. Corrective action for Dimension clinical chemistry system Microalbumin Calibrator, Dade…
  271. Corrective action for Accu Chek Aviva Plasma Import Test Strips, Servoprax
  272. Safety Information for Bone cement, BIOMET
  273. Urgent Field Safety Notice for Comprehensive Reverse Shoulder System by Biomet…
  274. Lot Recall for Anti-Gangliosid Dot, GA Generic Assays GmbH
  275. Recall for Neos Vanadium Excavators, Kerr
  276. Corrective action of Focal and Monaco treatment planning software, Elekta Inc. IMPAC…
  277. Safety Information for the MicroSil IF and MicroSil IFT intraocular lenses, HumanOptics AG
  278. Urgent Field Safety Notice for EliA Intrinsic Factor Well by Phadia AB
  279. Recall for Dade Hepzyme, Siemens
  280. Recall for Aquaflow Collagen Glaucoma Drainage, Staar Surgical
  281. Recall for Sinus Packing, Fuhrmann GmbH
  282. Corrective action for the MobileDiagnost wDR X-ray systems, Philips Medizin Systeme
  283. Lot-Recall of four different surgical sutures, Aesculap
  284. Safety Notice for the SwitchPoint Infinity, Booms, Lights, and Flat Panel systems, Stryker
  285. Urgent Field Safety Notice for OZONOSAN Keimstop by Dr. J. Hänsler GmbH
  286. Urgent Safety Notice for Invacare wheelchairs REA Focus, Spirea and SpinX, Invacare Rea AB
  287. Urgent Field Safety Notice for DICOM Importer Pro, medavis GmbH
  288. Safety Notice for TACTYS - PIP prosthesis, Stryker Osteosynthesis
  289. Urgent field safety notice for ONLINE TDM Gentamicin assay, Roche Diagnostics
  290. Urgent Field Safety Notice for HemosIL AcuStar ADAMTS13-Activity Assay by Instrumentation…
  291. Field Safety Notice for Flocare Infinity Enteral Feeding Pump from Nutricia Medical Device…
  292. Recall for the intraocular lens “SENSAR Foldable IOL with OptiEdge”, AMO
  293. Safety Notice for Silentia bed-screens, Silentia AB
  294. Urgent field safety notice for Controller, HeartWare
  295. Urgent field safety notice for ST AIA-PACK iE2 / hsE2, Tosoh Europe N.V. / S.A.
  296. Field Safety Notice about corrective actions concerning STERRAD 100S Sterilizer
  297. Recall of PHYSIOMESH flexible composite mesh, Ethicon
  298. Urgent field safety notice for disposable paediatric ventilation circuit VentStar…
  299. Safety Notice for the product Aquilion, Toshiba Medical Systems Corporation
  300. Urgent field safety notice for Pedicle Starter Awl, icotec AG
  301. Lot recall of CinchLock SS Knotless Anchor with Inserter and CinchLock Flex Anchor with…
  302. Important Information for Potassium liquirapid, HUMAN
  303. Urgent Field Safety Notice for Jaundice Meter by Draeger Medical Systems Inc.
  304. Information for stretchers, Stryker
  305. Corrective action for Accu-Chek Inform meters, Roche
  306. NEXGEN Complete Knee Solution quick-connect handle
  307. Recall / Corrective action for Triage Meter Pro, Software Version 5.02, BIOSITE
  308. Accu-Chek Aviva glucose meter
  309. Batch recall of LEGION HINGE KNEE FEMORAL ASSEMBLY, Smith & Nephew Inc.
  310. Recall for HiRes 90K Cochlea Implant, Advanced Bionics
  311. Safety Notice/Corrective action for Universal Ovens and incubators models UNE 800, UFE…
  312. Corrective action for the Fluitest CREA PAP and for all products based on the “Trinder…
  313. Safety Notice for the device GE Centricity™ PACS, GE Healthcare
  314. Safety Notice for the MOSAIQ Oncology-Information system of Elekta IMPAC Medical Systems…
  315. Safety Notice for the OrthoPilot® Navigation system, Aesculap
  316. Recall for VITROS Chemistry Products PHYT Slides, Ortho-Clinical Diagnostics
  317. Safety Notice for the superDimension systems with software version 4.0-4.9
  318. Urgent Field Safety Notice for Jackson-Pratt Perforated & Hemaduct Wound Drainage by…
  319. Urgent Field Safety Notice for Dade Actin Activated Cephaloplastin Reagent by Siemens…
  320. Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V.
  321. Urgent field safety notice for SERVO-i/s ventilator systems software 8.00.00, Maquet…
  322. Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB
  323. Recall of Siemens Healthcare Diagnostics Diagnostics / NovaTec Immundiagnostica for…
  324. Safety Notice for Vitrea Core 1.2 and 1.3, Vitrea Enterprise Suite, Vital Images, Inc.
  325. Safety Notice for XPREZZON-Bedside-Monitor, Spacelabs Healthcare
  326. Recall for Legionella BCYE Growth Supplement, OXOID Ltd./Thermo Fisher Scientific
  327. Corrective Action for ABL 90 FLEX, Radiometer
  328. Urgent Safety Notice for the BD CD56 PE-Cy™7 reagent, Becton, Dickinson & Company, BD…
  329. Urgent Field Safety Notice for Malte, Malte-Outdoor, Marcy by Schuchmann GmbH & Co. KG
  330. Recall for M06K14-34 (gabControl Troponin I-Test), gabmed
  331. Corrective action/Recall because of a software bug (cobas u 411), Roche
  332. Safety Notice for the digital linear accelerators of type ARTISTE™ and ONCOR™, Siemens…
  333. Urgent Field Safety Notice for Fenom Pro Asthma Monitor by Caire Diagnostics
  334. Field Safety Notice of battery caps in insulin pumps
  335. Corrective Action for Access Total βhCG, Beckman Coulter
  336. Recall of Sekisui Medical TPLA Calibrator Set and Sekisui Medical TPLA Control Set
  337. Recall regarding the device Strep. A Cassette, Dialab
  338. Urgent Safety Notice for the E.cam and Symbia E collimator carts, Siemens Medical…
  339. Corrective action for the iChemVELOCITY systems using iChemVELOCITY Urine Chemistry…
  340. Recall of Persona Trabecular Metal Tibial Plate Select Instruments, Zimmer Biomet / Zimmer…
  341. Sinapi Thoraxdrainage-Systeme
  342. Corrective Action/Recall for SYNCHRON Systems Glucose (GLU) Cartridge Reagent for use on…
  343. Recall of Plasmacup® DC polyethylene liners, Aesculap
  344. Urgent Field Safety Notice for KWIK-STIK Trichosporon dermatis & KWIK-STIK YST by…
  345. Urgent Field Safety Notice for ENROUTE Transcarotid Stent System by Silk Road Medical…
  346. Urgent Field Safety Notice for Soft-Trans Embryo Transfer Catheter by Cook Incorporated
  347. Corrective action for Dade Cardiac TL Assayed Cardiac Marker Control, ThermoFisher
  348. Reformat Image Flip Issue associated with MRI Systems, GE Healthcare
  349. Urgent Field Safety Notice for Monopolar Curved Shears by Covidien llc
  350. Corrective action for Hemoglobin F and A2 Control, Tosoh
  351. Corrective action for the Philips Expression MR200 MRI Patient Monitoring System, Philips…
  352. Urgent Field Safety Notice for TLS2 35C by Starion Instruments Inc
  353. Important Safety Information for Scooter Leo, Invacare
  354. Urgent Safety Notice: Corrective action for the Affinity™ Four Birthing Bed - Lift-Off…
  355. Urgent Field Safety Notice for Access CT by Philips Healthcare (Suzhou) Co.,Ltd
  356. Recall of Pentapharm extended for reagents ex-TEM
  357. Urgent field safety notice for Homepump C-Series Silicone Elastomeric Pumps (non-DEHP)…
  358. Field Safety Notice to the COLLEAGUE Triple Channel Volumetric Infusion Pump, Baxter
  359. Field Safety Notice for electrophysiology system Carto 3, Biosense Webster
  360. Lot Recall for the Marathon Flow Directed Micro Catheter, ev3 Neurovascular
  361. Lot Recall of the Vector TAS Screws, ORMCO
  362. Safety Notice for COGNIS CRT-Ds and TELIGEN ICDs, BOSTON SCIENTIFIC
  363. Lot Recall of 4R82 tube clamp adapter, Otto Bock Healthcare GmbH
  364. Information for the multiFiltrate dialysis system, Fresenius
  365. Safety Notice for Fred easy and Fred Easy Paediatric, Schiller
  366. Safety Notice for MAC 800, GE Healthcare
  367. Recall for Lynoamp BC, Sysmex Europe
  368. Recall for Enzygnost Anti-Helicobacter pylori II/IgG, Siemens
  369. Urgent Field Safety Notice for Gentle Threads Interference Screw by Biomet Orthopaedic LLC
  370. Information for TriniCHECK Control Level 3, Trinity Biotech
  371. Safety Notice for the Footswitch of the Allura FD10, FD20, CV20 systems and the Allura…
  372. Urgent Field Safety Notice for Oceane+ Hüftschäfte (Standard / Lateralisiert /…
  373. Safety notice on angled air hose adapter GA508R used for air motor, Aesculap AG
  374. Lot Recall for FASTx Sternal Intraosseous Device, Pyng Medical
  375. Corrective Action / Recall for Alkaline Phosphatase Calibrator (KC330), Siemens
  376. Urgent Safety Notice for the Stiegelmeyer hospital beds, Joh. Stiegelmeyer GmbH & Co. KG
  377. Urgent Field Safety Notice for Defigard Touch 7 by Schiller Medical SAS
  378. Lot Recall for Prostaflow catheters, Coloplast
  379. Field safety notice concerning anomaly identified when using 4DITC in combination with…
  380. Corrective action for the Expression IP5 Information Portal, Philips Healthcare
  381. Recall of Biomérieux for Selenit F Bouillon
  382. Safety Notice for Affinity™ Four Birthing Beds, Hill-Room
  383. Recall for AngioSculpt® PTA Scoring Balloon Catheter, AngioScore Inc.
  384. Lot Recall for Dimension Vista Vancomycin Flex reagent cartridge, Siemens Healthcare…
  385. Corrective Action for Thermo Fisher TCAutomation / enGen Laboratory Automation Systems…
  386. Corrective action / recall for all PT- / APTT-based IL Locked Test Groups on ACL Elite…
  387. Safety Notice for STERRAD® CYCLESURE® 24 Biological Indicator, ASP (Johnson&Johnson…
  388. Urgent Field Safety Notice for Sauerstoffkatheter CH10 by ASSAmed GmbH
  389. Corrective action and recall for FACSDiva Software, Becton Dickinson
  390. Safety Notice for 5008 tubing systems, Fresenius
  391. Information for the automated external defibrillators HeartStart HS1 and HeartStart FRx…
  392. Urgent Field Safety Notice for Diverse Neurosurgical procedure kit, no.-medicated…
  393. Medtronic SynchroMed II Implantable Drug Infusion Pumps - pumba mootor võib ootamatult…
  394. ABL700 and ABL800 Flex series
  395. Deas
  396. Laerdal Suction Unit - July 2016 FSN, Laerdal Suction Unit - September 2016 FSN
  397. Safety Notice for the product VISCOJECT-BIO 1.8 Cartridge Set, Medicel AG
  398. Corrective action for Medumat Transport, Weinmann Geräte für Medizin
  399. Urgent Field Safety Notice for Comprehensive by Biomet Orthopedics, LLC
  400. Safety Information for Thermo Scientific Microm HM550 Cryostat, Thermo Fisher Scientific
  401. Corrective Action/Recall for CELLSEARCH Circulating Tumor Cell Control Kit, Ortho-Clinical…
  402. Safety Notice for SureSigns Patient Monitor, Vital Signs Monitor and Vital Signs Viewer…
  403. Urgent Field Safety Notice for EKOS Control System 4.0 - Connector interface cabl by EKOS…
  404. Corrective action for Rival® PTA Dilatation Catheters, Bard Peripheral Vascular (BPV)
  405. Safety Notice for HeartStart Vehicle Wall Mount, Philips
  406. Urgent Field Safety Notice for Biosyn + Maxon + Endo Stitch + Polysorb by Covidien llc
  407. Recall of CD Horizon Agile Device, Medtronic
  408. db619fb2-6d57-7704-199e-76e2f41d3d02
  409. Field Safety Notice concerning a problem with the TxT table for Siemens Linear Accelerator…
  410. Recall for CircuCool™ Tubing Set, Boston Scientific
  411. Lot Recall for Urine Drainage Bags, Unomedical
  412. Corrective action for Bond Polymer Refine Red Detection System and Chromoplex 1 Dual…
  413. Urgent Safety Notice concerning the use of the Ultrafilter U9000, Gambro Dialysatoren GmbH
  414. Urgent Field Safety Notice for Monnal EVA expiratory s.t. - Single Use version (UU) and…
  415. Corrective action and recall for DELFIA and AutoDELFIA Neonatal-17α-OH-Progesteron-Kits…
  416. Recall of the 200 mm sinus-SuperFlex-635 self-expanding nitinol stent system, optimed…
  417. Recall for new bottles for the CELLTRACKS AUTOPREP System, Ortho-Clinical…
  418. Urgent Field Safety Notice for therascreen EGFR RGQ PCR Kit (24), V2 and therascreen EGFR…
  419. Recall of VITEK 2 GP identification cards, BioMérieux
  420. Recall for PERIMOUNT aortic, PERIMOUNT Plus, PERIMOUNT Magna Ease valves, Edwards…
  421. Information about the Instructions for Use for the EG-3870UTK Ultrasound Video…
  422. Corrective action for the Philips HeartStart XL+ Defibrillator/Monitor, Philips Healthcare
  423. Safety Notice for CT ASPHINA 409 MP intraocular lenses, Carl Zeiss Meditec SAS
  424. Labeling Updates Notification for Medtronic’s Deep Brain Stimulation (DBS), Medtronic Inc.
  425. Field Safety Notice for Path Finder and InCompass T-Handle Driver from Abbott Spine Inc.
  426. Urgent Field Safety Notice for Visitec. Visiwipe,., Instrument Wipe 7.3 x 73cm by…
  427. Recall for SN connector, article 1703, Serumwerk Bernburg
  428. Urgent Field Safety Notice for T.E.S.S. Reverse Shoulder System by Biomet Merck France
  429. Urgent Safety Notice for Varian Clinac® linear accelerator, Varian medical systems
  430. Urgent Field Safety Notice for CyberKnife Robotic Radiosurgery System by Accuray…
  431. Recall for the silicon tube 1008, Hippokratec GmbH
  432. Lot Recall for Biomet Bone Cement V, BIOMET
  433. Corrective action for the Minstrel Patient Transfer Lift with Scale, ArjoHuntleigh
  434. Safety Notice for all CyberKnife Treatment Planning Systems, Accuray
  435. Information for Alaris® GP, Cardinal Health
  436. Recall for RSP Socket Reamer and the RSP Baseplate Rim Planer, Encore Medical
  437. Urgent Field Safety Notice for Druckmess-Sets; 1-fach, 2-fach, oder mit ZVD-Messschenkel…
  438. Recall of the Sihouette Axial Torque Wrench from Zimmer Spine USA
  439. Recall for VIDAS EBV VCA-EA IgG, BioMérieux SA
  440. Recall for Merit Valved One-Step Centesis Drainage Catheter, Merit Medical
  441. Recall for the HKS Sets - Customized Catheter Kits, Maquet Cardiopulmonary AG
  442. Recall of all Softcup oesophagus stents, Micro-Tech Nanjing Co. Ltd.
  443. Field Safety Notice concerning Artiste digital linear accelerator
  444. Lot Recall for Arrow International Epidural Catheterization Kits with FlexTip Epidural…
  445. Urgent Field Safety Notice for Maestro by Ortho Organizers, Inc.
  446. Corrective action for Galileo Echo, Immucor
  447. Safety Notice for the Chrystal LT 201 X-ray system from the manufacturer XCAN AG, MTS…
  448. Recall for Pitt-Easy FBR Implants, Sybron Dental Specialities
  449. Lot Recall for the infusion system Octopus, Vygon
  450. Safety Notice for the Servoport 3000 m suction device, Servona GmbH
  451. Urgent Field Safety Notice for Anti-Parvovirus-B19-ELISA (IgM) by EUROIMMUN Medizinische…
  452. Urgent Field Safety Notice for Radiel Artery Catheterization Set by Arrow International…
  453. Micro-Needling devices and Needle Cartridges Priority 2 – Warning
  454. Recall of Olympus for Ferritin reagent
  455. Urgent Field Safety Notice for AMPLATZER TorqVue LP Delivery System by Abbott Plymouth…
  456. Urgent field safety notice for Accu-Chek Insight insulin pump system, Roche Diabetes Care…
  457. Urgent field safety notice for DANUBE HP supply system, Air Liquide Medical Systems
  458. Recall of PSS Midas Rex Sagittal Saws Models ES300 / ES300-R / ES310 / ES310-R, Medtronic
  459. Recall for Ablation System Foot Switch, Boston Scientific Corp.
  460. Recall for Pronto Short Extraction Catheter, Vascular Solutions
  461. Recall of Siemens Healthcare Diagnostics for Quadriga BeFree System
  462. Recall of Software application cards Model 8870BBG 01, Medtronic
  463. Safety Notice for V-Sign™ 2 Sensor, part of the SDMS (SenTec Digital Monitoring System)
  464. Recall (phase 2) of the Trabecular Metal Reverse Glenosphere Helmets, Zimmer
  465. Recall for i-STAT cTnI cartridges, Abbott
  466. Recall / Corrective Action for UniCel Dxl Access Immunoassay Systems Wash Buffer II…
  467. Urgent Field Safety Notice for Q 700 by Sunrise Medical GmbH & Co. KG
  468. Safety Notice for the TrueBeam accelerator, Varian medical systems
  469. Urgent Field Safety Notice for Columbia CNA Aesculin Selective Agar / MacConkey No. 3…
  470. Urgent Field Safety Notice for DILAPAN-S by MEDICEM Technology s.r.o.
  471. Urgent Field Safety Notice for IPS e.max ZirCAD CER/inLab LT A1-A3 C17/5 by Ivoclar…
  472. Safety Notice concerning a corrective action of the HeartStart MRx monitor/defibrillators…
  473. Safety Notice concerning a corrective action of the HeartStart MRx monitor/defibrillators…
  474. Urgent Field Safety Notice for Progesterone Luminescence Immunoassay by IBL International…
  475. Urgent Field Safety Notice for Sentinex Pro/Smart Surgical gown by Lohmann und Rauscher…
  476. Recall for Tissue Morcellation System, Ethicon
  477. Recall of Promos Releasing Clamp and Promos Glenosphere Loosening Adapter from Smith &…
  478. Information about electrotherapy devices, Chattanooga Group
  479. Urgent Field Safety Notice for ICD and CRT-D by S.. Jude Medical Inc., Cardiac Rhythm…
  480. Urgent Field Safety Notice concerning recall of Xomed instrument trays, Medtronic GmbH
  481. Urgent Field Safety Notice for Global Total LP single step medium, 60mL by CooperSurgical…
  482. Recall of Variall Connecting Rod from Zimmer GmbH
  483. Recall self adhesive sterilisation bags, Medipack
  484. Urgent Safety Notice for the ceiling pendants SPR10, MZ Liberec a.s.
  485. Recall for the iTRACK250A, Canaloplasty Microcatheter Kit, Ellex iScience
  486. Safety information for Twist Drill, Biomet Microfixation
  487. Corrective action of the AW Server picture archiving and communication system, GE…
  488. Safety Notice for Presice Cryoablation Systems and SeedNet MRI Cryoablation Systems…
  489. Recall of all lots of the applicator part AL07289000 Rectal Retractor, Stainless…
  490. Safety Notice for the Fine Pressure Regulator, Synthes GmbH
  491. Field Safety Notice concerning the external pacemakers EDP 30/A and EDP 30/S as well as…
  492. Urgent Field Safety Notice for Bluephase Style by Ivoclar Vivadent AG
  493. OR-Table Yuno II
  494. Urgent Field Safety Notice for Flocare Gastrostomy tube (G-tube) - ENFit by Nutricia…
  495. Urgent Field Safety Notice for Vitamin D total II, Elecsys Vitamin D total II by Roche…
  496. Corrective action for HemoCue Glucose 201 RT Microcuvettes, HemoCue
  497. Safety notice for Vagus Nerve Stimulation Leads, Cyberonics

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