Orca1

Data catalog

International device safety notices

About 146K records

More records

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

  1. Urgent Safety Notice for "ViaCath" diagnostic catheters, VascoMed
  2. Recall of insertion guides for tracheal tubes, Medicoplast International GmbH
  3. Recall of all batches of the Hintegra® Total Ankle Prosthesis tibial and talar components…
  4. Problems with the Bloom Programmable Stimulator from Fisher Imaging
  5. Seattle Systems recalls prosthesis elements SSA 230 Socket Mounting Plate
  6. BioMerieux recalls the Slidex Rota-Kit 2
  7. Recall for Tryton Side Branch Stent, Tryton Medical
  8. Lot Recall for Continium™ Acetabular Systems Shell Inserter Adapter with and without…
  9. Information for the Software RenalSoft Observational Study v.2.0, RenalSoft v.1.1 and…
  10. Information for Zoll E Series Defibrillators, Zoll
  11. Another Safety Notice for Innova 2100IQ, 3100IQ and 4100IQ, GE Healthcare
  12. Information concerning the battery capacity of the Lifepak 20 defibrillators from…
  13. Information concerning the Contak Renewal 4 RF and 4 RF HE Defibrillators from Boston…
  14. Safety Notice for Sytec6000/8000, Lemage, ProSeed and ProSpeed, GE Healthcare
  15. Important Safety Information concerning Valvuloplasty Catheters of type VACS II and VACS…
  16. Recall for Biolox Delta Ceramic Head, Biomet
  17. Recall of Becton Dickinson for BD Oncomark CD2/CD7/CD3
  18. Information concerning the Contak Renewal 3 and 4, Vitality and Vitality 2 defibrillators…
  19. Urgent Field Safety Notice for Custom Tubing set by Maquet Cardiopulmonary GmbH
  20. Urgent Field Safety Notice for Medumat Standard 2 by WEINMANN Emergency Medical Technology…
  21. Urgent Field Safety Notice for Panther and Panther Fusion systems by Hologic Inc
  22. Urgent Field Safety Notice for Mechanisches/Pneumatisches Knie Genex by ORTHO-REHA Neuhof…
  23. Recall of tubes for liposuction by Microaire® Surgical Instruments
  24. Recall of the BD Vacutainer Safety Flow Lancets from Becton Dickinson
  25. Urgent Safety Notice for the Thoratec HeartMate II LVAS, Thoratec Corp.
  26. Recall for PillCam Express Video Capsule Delivery Device, Given Imaging
  27. Recall of Endopath®Probe Plus II Electrosurgical Suction Irrigation Products from Ethicon
  28. Corrective action of the Medical Ceiling Supply Units Alpha-Port, M-Carrier and M-Lifting…
  29. Recall of the MAV™ instruments of Medtronic
  30. Information for NexGen Complete Knee Solution Rotating Hinge Knee Srew Driver, Zimmer
  31. Urgent Field Safety Notice for Sensation, Captivator, Captivator II, Captiflex by Boston…
  32. Recall Xact Rapid Exchange Carotid Stent Systems, Abbott
  33. Urgent Field Safety Notice for PROGNOST ES / PROGNOST FS / PROGNOST S. by PROTEC GmbH &…
  34. Urgent Safety Notice for the HeartStart FR3, Philips Healthcare
  35. Safety Notice for GreenLight PV® Laser System, American Medical Systems
  36. Safety Notice for the XPED Pedicle Screw System, EXPANDING ORTHOPEDICS
  37. Corrective action of the surgical lights PowerLED 700 and H LED 700, Maquet
  38. Urgent Field Safety Notice for qLabs PT-INR Monitoring System by Micropoint…
  39. Recall of BCI 3180 Pulse Oximeter, Smiths Medical
  40. Safety Notice for the C-SVV system, Chronos Vision GmbH
  41. Recall of the All-Poly Cup of the Reflection Hip System from Smith & Nephew
  42. Urgent Field Safety Notice for Acuson NX2 , NX2 Elite, NX3, NX3 Elite, by Siemens Medical…
  43. Corrective action of BioMerieux for Quality Control Vidas
  44. Urgent Field Safety Notice for Charder Lift Scale by Charder Electronic Co., Ltd.
  45. Corrective action for the HAMILTON-G5/HAMILTON-S1 ventilators, Hamilton Medical AG
  46. Corrective action and recall for Ria-gnost OCFH07-FT3 (Lot-No. 162), OCFDO3-FT4 (Lot-No…
  47. Recall of DVR ePAKs, Zimmer Biomet
  48. Urgent field safety notice for Atrium Thoracic Catheters, Maquet Getinge Group
  49. Recall of ablation catheters from CryoCath
  50. Fresenius Kabi: Safety Notice for the blood bag systems COMPOFLOW, COMPOSTOP, COMPOFLEX…
  51. Batch recall of Intraocular lenses CT ASPHINA 409MP, Carl Zeiss Meditec AG
  52. Recall IMMULITE 2000 and 2500 CEA, Siemens
  53. Recall for Omniflush, B. Braun Melsungen AG
  54. Information for FDR Amulet, Fujifilm
  55. Urgent Field Safety Notice for NeoCoi1 3.0T GEMflex Coil with GE Healthcare 3.0T Scanners…
  56. Urgent Safety Notice for MEDUMAT ventilators with the blue test bag, WEINMANN Emergency…
  57. Corrective action for the CPAP ventilators PV101, PV101+, PV102 and PV102+, Breas
  58. Recall Hall Easy-Fit®, Medtronic
  59. Recall of the hip belt supplied with the products Mobile Advance Seat, Contoured Advanced…
  60. Information for Bemis Hi-Flow™ Suction Canister Lids, Bemis Manufacturing Company
  61. Corrective action for the ADVIA Centaur XPT System, Siemens Healthcare Diagnostics
  62. Urgent field safety notice for XRCISE STRESS ECHO MED, ERGO-FIT GmbH & Co. KG / cardiowise…
  63. Urgent Field Safety Notice for Handgriff mit und ohne Ratsche by VOMED Volzer…
  64. Recall and corrective action of Roche for Stago STA-R coagulation analyzers
  65. Urgent field safety notice for Kiwi Omni Cup, Clinical Innovations
  66. Urgent Field Safety Notice for FT4 RIA Tracer, BRAHMS GmbH
  67. Corrective action from Agen BioMedical, BioMerieux and Behnk Elektronik for Compact X…
  68. Enlargement of Instruction For Use for Genos MC finger­distractors from KLS MARTIN
  69. Recall of GEM Premier 4000 Glucose and Lactate Sensors due to falsely positive results…
  70. Corrective action and recall of Radiometer for capillary adapters for ABL5 blood gas…
  71. Information concerning the iris fixated phakic intraocular lenses Artisan and ArtiFlex…
  72. Urgent field safety notice for HemosIL Plasminogen, Instrumentation Laboratory / Werfen
  73. Recall of the C9054 SE™ Graft Tensioner Breakaway Pins with Graft Tension Calculator of…
  74. Information concerning the iris fixated phakic intraocular lenses Verisyse and VeriFlex…
  75. Recall of HeartMate PHP Catheter, Abbott
  76. Recall of the MicroTherapeutics SilverSpeed® .010´´ guide wires from Ev3 Neurovascular
  77. Urgent Field Safety Notice for Arrow EPIDURAL CATHETERIZATION Kits and Sets by Teleflex…
  78. Recall FlexCath® steerable sheath, Cryocath
  79. Safety Notice for radiotherapy treatment planning software iPlan RT dose, BrainLab
  80. Recall Deltec Cozmo, Smiths Medical
  81. Lot Recall for Stryker Stiletto Electrosurgical Probe, Stryker
  82. Urgent Safety Notice for PulseCath iVAC3L, Pulsecath B.V.
  83. Label error of Achalasia Balloon Dilators by Boston Scientific
  84. Recall of FlexTherm Heater Cooler Device, Sorin / LivaNova
  85. Recall of the TriActiv® ProGuard™ Embolic Protection Systems from Kensey Nash
  86. Recall for EV1000 system with software version 0.1.1.52, Edwards Lifesciences
  87. Urgent Safety Notice for the product D-Dimer Gen.2, Roche Diagnostics
  88. OLYMPUS TJF-Q190V/Q290V/Q170V DUODENOSCOPE
  89. EARLYVUE VS30 VITAL SIGNS MONITOR AND EARLYVUE VS3
  90. Urgent Field Safety Notice for 3M Surgical / 3M Specialty Clipper Blades by 3M Health Care
  91. Urgent Field Safety Notice for Lifepak 15 by Physio-Control, Inc.
  92. Medtronic recalls 4 and 8 Channel Electrode Boxes
  93. Recall of DAKO Envision™+, Dako Cytomation
  94. Information about OEC devices, GE Healthcare
  95. Urgent Field Safety Notice for Zenzy Arzteingabemodul by Dr. Heni Software GmbH & Co. KG
  96. Safety Notice concerning OEC devices, GE Healthcare
  97. Urgent Safety Notice for the automated external defibrillators HeartStart Home and OnSite…
  98. Recall for Access Estradiol Reagent Kit, Beckman Coulter
  99. Further Safety Notice for the automated external defibrillators HeartStart FR3, Philips…
  100. Urgent Field Safety Notice for XTREM electrophysiology catheter by ALCIS
  101. Urgent Field Safety Notice for Analytical column, MassChrom Free Metanephrines by…
  102. Security advice Balance-Trainer, Medica Medizintechnik
  103. Urgent Safety Notice for FX CorDiax High-Flux dialysers and FX CorDiax Haemodiafilters…
  104. Summary of Field Safety Notice – July 2016
  105. Safety Notice for XVI R4.5 (Incorrect MUs), Elekta
  106. Corrective action for the One Step hCG Pregnancy Test (strip), Dutch Diagnostics B.V.
  107. Information for HeartMate II, Thoratec Corp.
  108. Recall on the Integra Padgett™ Dermatome Power Supply Units, Integra
  109. Urgent Field Safety Notice for XO 4 Unit by XO Care A/S
  110. Recall Innex Knee Endoprosthesis, Zimmer
  111. Safety Information for AvantGuard 1600 beds - AvantGuard Li160A, Hill-Rom
  112. Recall for Millar disposable angiographic catheters, Millar Instruments Inc.
  113. Urgent Safety Notice/Update for the Expel™ APD and APDL Drainage Catheters, Boston…
  114. Urgent field safety notice for care beds VSA 644 and VS stand-up accessory, Mauser…
  115. Recall for Access Immunoassay System Total βhCG Reagent-Kit, Beckman Coulter
  116. Vygon recalls the Catheter Reservoir PR06x and PR07x
  117. Safety Notice for tergumed Extension, proxomed Medizintechnik
  118. Recall / Upgrade for AQT90 FLEX Analyzer Software and Operator’s Manual, Radiometer
  119. Urgent Field Safety Notice for REANIBEX 300y,REANIBEX 500 by Osatu, S. Coop.
  120. Urgent Field Safety Notice for Pall Ultipor 25 Breathing System Filter by Pall Medical, A…
  121. Safety Notice for Getinge 9100-Series Washer Disinfectors, Getinge
  122. Recall for Dimension Vista LOCI Reaction Vessel, Siemens
  123. Urgent Field Safety Notice for Patientenset für R100 by Metran Co. Ltd.
  124. Lot recall for GlideScope Video Laryngoscope Titanium Single-Use (SU) Blades, Verathon…
  125. Warning regarding the Cervical Disc System from SPINAL KINETICS
  126. Recall Kryosonde, H.P. Braem AG
  127. Recall for Sterican 30 G Needles, B. Braun Melsungen
  128. Urgent Field Safety Notice for Alaris Extension Sets, Low Sorbing (PE) by Shanghai Kindly…
  129. MetaVision Suite
  130. Urgent Field Safety Notice for ProGrade by Philips Medical Systems DMC GmbH
  131. Potential discrepancies in IMRT CIAO outline visualization, Varian medical systems
  132. Recall of the Discovery In Line Disc Inserter ASSBY from DePuy
  133. Urgent Field Safety Notice for Original Perfusor Line by B. Braun Melsungen AG
  134. Corrective action for Access Immunoassay Systems CEA, Beckman Coulter
  135. Recall Renoskin bilayer matrix, Perouse Plastie
  136. Safety Notice for aortic root bioprosthesis TLPB-A Supra 21, 23, 25 mm, Freelife
  137. Urgent Safety Notice for the transfer mattress, Schmitz u. Söhne GmbH & Co. KG
  138. Urgent field safety notice for RayStation 3.0 / 3.5 / 4.0 / 4.5 / 4.7, RaySearch…
  139. Corrective action of the Microgenics MAS CardioImmune XL Assayed Cardiac Marker Control…
  140. Urgent Safety Notice for the Disinfection and Cleaning of Sorin Heater Cooler 1T and 3T…
  141. Updated Instructions for Use for the Nellix EndoVascular Aneurysm Sealing System…
  142. Information for the D-TRONplus and Accu-Chek D-TRONplus insulin pumps from Roche
  143. Replacement of PO cable connecting C-arm to monitor cart, GE Healthcare
  144. Software-failure in Spacelabs Monitors from Edwards
  145. Lot recall of AO „2 in 1“ cannulated drill dia. 2.2/3.0 mm L. 32 mm - STERILE Reference…
  146. Information for Defigard 5000, Schiller
  147. Lot recall of Streptococcal Grouping Kit (DR0585A), Oxoid Limited
  148. Lot recall of NuPortCT and C-PortCT port catheter systems containing F9.6 silicone…
  149. LeMaitre recalls the Pruitt Aortic Occlusion Catheter
  150. Information about Coronary Imaging Catheter from Boston Scientific
  151. Urgent field safety notice for Cios Alpha mobile C-Arm system, Siemens Healthcare GmbH
  152. Urgent Field Safety Notice for V680 Ventilator by Respironics California, Inc.
  153. Information about the iLab Ultrasound Imaging system from Boston Scientific
  154. Lot Recall for Tyvek Heat-Seal Pouch, Advanced Sterilization Products
  155. Recall for the Light probe Pin-Point, Ivoclar Vivadent
  156. Urgent Field Safety Notice for Stratec GEMINI und Stratec GEMINI Combo by STRATEC SE
  157. Urgent field safety notice for fT4-CTK Kit, DiaSorin S.p.A
  158. Urgent Field Safety Notice for O-Arm 1000 by Medtronic Navigation Inc.
  159. Corrective action for D.light operating lamps, DKL Chairs GmbH
  160. Biomet recalls the Helios Star Design revision shaft
  161. Recall of the Instant-View Troponin I WB/Serum Cassettes from Alfa Scientific Designs
  162. Corrective action for the Engstrom ventilators, GE Healthcare
  163. Corrective action of ABL80 from Radiometer
  164. Recall Vena Cava Filter, ALN implants chirurgicaux
  165. Batch recall for ENT single-use suction tubes, Spiggle & Theis Medizintechnik GmbH
  166. Urgent Field Safety Notice for Padlock Clip defect closure system by United States…
  167. Urgent Field Safety Notice for CombiSet für die Ophthalmologie by PAUL HARTMANN AG
  168. Important information for the Accu-Chek® Insight insulin pump cartridge (self-filled)…
  169. Lot Recall for Super Arrow-Flex(R) Percutaneous Sheath Introducer Set with Integral…
  170. Sedana recalls the Instruction for Use
  171. Lot recall of DCI Dynamic Cervical Spine Implant, PARADIGM SPINE
  172. Corrective action for the Triathlon Distal Capture Assembly, Stryker
  173. Urgent Field Safety Notice for Tack Endovascular System by Intact Vascular, Inc
  174. Smith & Nephew recalls the Knee-System Genesis II
  175. Recall for Loops Gefäss-Schlingen, Dücker Medizintechnik
  176. Stryker recalls Gamma lag screw
  177. Recall of the lot number 07B1292050 of the stopcock Discifix C from B.Braun
  178. Recall for AXP Bag Sets, ThermoGenesis
  179. Safety Notice for Biphasic LIFEPAK® 12 Defibrillator/Monitors series, Physio-Control
  180. Recall RP/VARD/20 and RP/VARD/35, MEDEX
  181. Safety Notice for the use of sandblaster devices, 3M Espe
  182. Recall for the Trauma DHS/DCS Impactor, DePuy Synthes
  183. Urgent Field Safety Notice for EliA anti-TSH-R Well by Phadia AB
  184. Corrective action for the GentleLase Pro laser system, Candela Corp.
  185. Urgent Safety Notice for the Autostainer instruments, Dako North America, an Agilent…
  186. Urgent field safety notice AX004/15/S for AXIOM Artis and Artis zee systems, Siemens…
  187. Urgent field safety notice for Codman Microcoil Delivery Systems and Detachment Control…
  188. Recall for "Exxcel Soft Standard Wall Vascular Graft", MAQUET
  189. Safety Notice for the Ultimate Bath Chair, Columbia Medical
  190. Recall for ProcedurePak, Mölnlycke
  191. Safety Notice for Infinia systems, GE Healthcare
  192. Recall of NPT7 cartridges, Radiometer
  193. Urgent field safety notice for ceiling unit CU 5001/3 and CU 3-21/23, MÖLLER-WEDEL GmbH &…
  194. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
  195. Therapy failure of the Guidant ICD Contak Renewal and Renewal
  196. Recall Dimension TPSA Flex reagent cartridge, Siemens
  197. Safety Notice for ACUSON Sequoia ultrasound system, Siemens
  198. Recall LASSO® 2515, Biosense Webster
  199. Recall for SwiftLink catheter connectors, Siemens
  200. Corrective Action for Auto D-Dimer Control, Level 2, Trinity Biotech
  201. Safety Information and Recall for Penumbra Coil 400, PENUMBRA Inc.
  202. Weight restrictions for Bicontact SD and Bicontact SD-Revision implants from Aesculap
  203. Urgent Field Safety Notice for Philips Azurion, Philips Allura by Philips Medical Systems…
  204. Corrective action for Vitros Chemistry Products CRBM Slides, Ortho
  205. Information for the GAMMAMED plus-, the GAMMAMED plus 3/24- and the…
  206. Recall for OIC Cage, Stryker
  207. Updated Safety Notice for GemStarInfusion System, Hospira Inc.
  208. Urgent Field Safety Notice for NovaSeq 6000Dx by Illumina, Inc.
  209. Field Safety Notice regarding NIST adaptors for Oxygen and AIR, GCE
  210. Corrective action and recall for Accu Chek Inform of the manufacturer Roche
  211. Safety Notice for the product LP Rotate, Össur
  212. Recall and corrective action for Coulter LH 500 Hematology Analyzer PN 178832, 178833 und…
  213. Recall of Plastipak Syringe, Catheter tip with Luer slip adapter 100 ml, Becton Dickinson…
  214. Information of a potential malfunction and hence hazard to patients when using syngo…
  215. Corrective action for the ExacTrac 6.x Patient Positioning System, Brainlab AG
  216. Urgent Field Safety Notice for Mölnlycke Procedure Trays & Single Packed Shielded Bladed…
  217. Corrective action for ADVIA Centaur, Siemens
  218. Lot Recall of two products for the paediatric infusion, Smiths Medical Deutschland GmbH
  219. Corective action of the Digital Mammographiesystem MAMMOMAT NovationDR from Siemens
  220. Information for “Phosphate Buffered Saline”, Baxter
  221. Corrective Action for CELL-DYN 3700SL and CELL-DYN 3700CS, Abbott
  222. Urgent field safety notice for Universal SlingBar 350 / 450 / 600 (may be bundled with…
  223. Recall of the SynchroMed EL implantable programmable pumps from Medtronic
  224. Urgent Field Safety Notice for Philips Azurion, Philips Allura by Philips Medical Systems…
  225. Recall for In-situ Bender/Cutter wide and narrow, Synthes
  226. VITROS GLU Slides
  227. Recall of EP4™ Computerized Stimulators from EPMEDSystems
  228. Corrective action for the product ED FLOW, Getinge Lancer
  229. Corrective Action for Automated Hematology Analyzer XP-300, Sysmex
  230. Urgent Field Safety Notice for mint Lesion by Mint Medical GmbH
  231. Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH
  232. Recall of the trimming handles 205530000, 205540000 and 205550000 from pfm
  233. Safety Notice for Oncentra Prostate 3.1, Nucletron
  234. Update of Safety Notice for GemStar Infusion System, Hospira Inc.
  235. Urgent Field Safety Notice for IQon Spectral CT by Philips Healthcare (Cleveland)
  236. Urgent Field Safety Notice for DeepUnity Viewer 2.x by DH Healthcare GmbH
  237. Recall Hemovac, HAS, Surgivac, Infection Control Evacuator and Mini-Hemovac, Zimmer
  238. Urgent Field Safety Notice for Natrium Citricum 4% by Biomedica, sopl s.r.o
  239. Recall of Olympus for ferritin reagent
  240. Recall EEA Stapler, Covidien
  241. Suspension of usage of all medical devices of Shelhigh
  242. Recall of the Triglycerides FS 5 minute endpoint version and the Triglyceride FS 10 minute…
  243. Safety Notice for CROSS 4000 MED / CROSS 4000 S MED, Ergo-Fit
  244. Recall of Omnitest plus Control control solution from Braun Melsungen
  245. Safety Notice for Carescape Monitor B850, GE Healthcare
  246. Recall of the CUSA® Excel/CUSA® Excel+ 23 kHz Sterile Torque Wrench, Integra LifeSciences…
  247. Strep A Rapid Test Strip
  248. CRYOCOR recalls the Model 1200 series cryoablation catheters
  249. Recall of Human for Potassium Liquirapid
  250. Urgent Field Safety Notice for LEGION HK DISTAL FEMORAL WEDGE SZ5 5MM by Smith & Nephew…
  251. HeartWare Inc. HVAD Pump Implant Kit - HVAD toiteallika halduse ja funktsiooni Autologs…
  252. Pilling Clear Advantage Disposable Aortic Punch
  253. Dako Autostainer instruments - puuduv komponent
  254. SEERS Medical Bariatric Drop End Couches – Single & Dual Foot Sections
  255. CADD-Solis Ambulatory Infusion Pump
  256. Information for Butterfly Winged Needle Infusion Set, Hospira
  257. Lot Recall of reusable surgical gowns and drapes, Bardusch Textil-Mietdienste GmbH
  258. Corrections in soft- and hardware of Ipump from Baxter
  259. Recall by Endoart SA
  260. Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy
  261. Information concerning a possible damage of the sterile packaging from Celon
  262. Urgent Information for GoldLine Rocker Switch Pencil, ConMed Electrosurgery
  263. Safety Notice for Angiostar, Multistar, Neurostar, Coroskop and Bicor systems, Siemens
  264. Safety Notice for Luxtec® MLX Light Source, Integra
  265. Urgent field safety notice for deltastream MDC, i-cor and iLA activve consoles, Medos…
  266. Urgent Field Safety Notice for BonAlive putty MIS by BonAlive Biomaterials Ltd
  267. Corrective action of the Architect Folate reagent for the use on Architect i2000 and…
  268. Safety Notice for Philips IntelliVue Clinical Information Portfolio Release D.0, D.02 and…
  269. Urgent Field Safety Notice for Multiva 1.5T by Philips Healthcare (Suzhou) Co.,Ltd
  270. Field Safety Notice from Johnson & Johnson Medical GmbH for implantable infusion pump…
  271. Recall Clinitest hCG Cassette, Siemens
  272. Recall of PO830SU / PO831SU / PO833SU, Aesculap AG
  273. Recall of Becton Dickinson for BD Vacutainer Glass Citrate Tubes
  274. Recall of DPC Biermann for Immulite CEA
  275. Safety Notice for Advantage Workstation/AdvantageSim MD, GE Healthcare
  276. Safety Notice for AvantGuard 1200, CareAssist, Hill Rom 1000 and Advanta 2, Hill ROM
  277. Safety Information about Blood Leak Detectors of single 4008 & 5008 dialysis system…
  278. Safety Notice for OEC Fluorostar 7900, GE Healthcare
  279. Safety Notice for the Acuson P300 ultrasound system, Siemens
  280. Urgent Field Safety Notice for mint Lesion by Mint Medical GmbH
  281. Software upgrade for Aquarius, Edwards Lifesciences
  282. Urgent Field Safety Notice for UniMatch Plus Software by One Lambda Inc.
  283. Corrective action for IgM OSR6146, Olympus
  284. Recall for ENDOPATH ® ETS-FLEX 45, Ethicon Endo-Surgery
  285. Urgent Field Safety Notice for IMMULITE 2000/IMMULITE 2000 XPi Sex Hormone Binding…
  286. Correct fitting of Distal Covers MAJ-311/411 for duodenoscopes from Olympus
  287. Safety Notice for Implantable Cardiac Monitors (Models CONFIRM DM2100 and DM2102), St…
  288. Corrective Action/Recall for MIKRO 120 centrifuge, Andreas Hettich GmbH & Co. KG
  289. Urgent Field Safety Notice for SERVO-n by Maquet Critical Care AB
  290. Important Safety Notice for latex breathing bags, Dräger
  291. Urgent Field Safety Notice for KV-5 Suction Pump / Patient Connecting Tube MAJ-103…
  292. Urgent Field Safety Notice for Cortisol Saliva ELISA by IBL International GmbH
  293. Lot recall of Bone Wax Stick, B. Braun Surgical S.A.
  294. Possible fractures of power supply 757L16-1 from Otto Bock
  295. Recall for RX Plastic Biliary Stents, Boston Scientific
  296. SOMATOM go
  297. Corrective action of the Storz Equipment Trolleys 29003 NEAG, NAG, NEG and WGAG from…
  298. Recall of Diasys for Phosphorus reagent
  299. Recall of the artificial saliva solution Salinum, Sinclair Pharma
  300. Important Safety Notice for the Elekta Precise™ Tables, Elekta Ltd.
  301. Recall and corrective action of Beckman Coulter for Synchron Clinical Systems Potassium…
  302. Urgent field safety notice for ProteusPLUS and ProteusONE, IBA
  303. Information concerning Camera Cover for Karl Storz Video Mediastinoscope, Medical…
  304. Recall of several knee, hip and shoulder prosthesis, Biomet
  305. Recall of adjustable drill stops used with Atlantis® / Premier® / Vertex® systems…
  306. Urgent field safety notice for VERSAJET II Hydrosurgery System Console, Smith & Nephew…
  307. Recall for BIOPLATE Sterile Kits, Codman
  308. Urgent Field Safety Notice for CLEO by Hoggi GmbH
  309. Urgent Field Safety Notice for Hemochron Signature Elite by Accriva Diagnostics, Inc. dba…
  310. Recall of infusion and transfusion sets, Becton Dickinson
  311. Recommendations concerning the phenox® Clot Retrievers from Phenox
  312. Field Safety Notice about an issue associated with the Corometrics 250 Maternal/ Fetal…
  313. Medicel recalls the Viscoject Cartridge Sets LP604240M
  314. Information from Siemens Medical Solutions
  315. Safety Notice for Synchrony Respiratory Tracking System, Accuray
  316. Lot recall for Silverline Lumbar Drainage Catheter, Spiegelberg GmbH & Co. KG
  317. EXALT Model D Single-Use Duodenoscope
  318. Recall of the ambIT Intermittent Ambulatory Infusion Pump from Sorenson
  319. Recall of the scissor blades 4393040 ModuBlade “Metzenbaum”, Richard Wolf GmbH
  320. Recall for Lactosorb Trauma Plate, Biomet
  321. Urgent Field Safety Notice for ClinCal Whole Blood Calibrator Immunosuppressants by RECIPE…
  322. Recall for Crossfire Console, Stryker
  323. Information for IGRT table top, Siemens
  324. Safety Notice for CARESCAPE CIC Pro v5.1 on MP100 hardware, GE Healthcare
  325. Labeling error of the Obtryx™ Transobturator Mid-Urethral Sling System, Boston Scientific
  326. Potential malfunction of the brake relay of the Siemens AXIOM Iconos R100, Siemens…
  327. Safety Notice for “NX” - Modality Workstation, AGFA HealthCare
  328. ield Safety Notice concerning potentially incorrect values of diffusion/perfusion maps…
  329. Urgent Field Safety Notice for ARCHITECT Estradiol Reagent, Alinity i Estradiol Reagent…
  330. Plus Orthopedics recalls the Cancellous Bone Screw 6.5 x 50 mm
  331. Update for Digital Linear Accelerators of type MEVATRON™, PRIMUS™, ONCOR™ and ARTISTE™…
  332. Adisory Notice for the Matrix Spine System, Synthes
  333. Field Safety Corrective Action for the OctoNova Hemofiltration Device, Nikkiso Europe GmbH
  334. Recall and corrective action of Abbott for the software of Cell-Dyn 3500 and Cell-Dyn 3700…
  335. Safety Notice for VariSource iX console, Varian Medical Systems
  336. Lot recall of Beacon EUS delivery system needles, Medtronic
  337. Information for Mevatron and Oncor, Siemens
  338. Sicherheitshinweis zur Lüfterbaugruppe bestimmter Intra-Aortalen Ballonpumpen-Systeme…
  339. Safety Notice for the Pinnacleɜ Radiation Treatment Planning System, Philips Healthcare
  340. aap Biomaterials GmbH & Co. KG recalls certain lots of the EASYMIX Snorkel Revision
  341. Urgent Field Safety Notice for Mopyc - Stem; Radial Head Prosthesis by TORNIER SAS
  342. Corrective action affecting different ICDs from Guidant
  343. Field Safety Corrective Action for Coban 2 and Coban 2 Lite (compression layers only), 3M…
  344. Corrective action of the BEP 2000 / BEP 2000 Advance System from Dade Behring
  345. Recall for Wallaby III Femoral Components, Zimmer
  346. Urgent Field Safety Notice for Untersuchungs- und OP-Leuchten by MAQUET SAS
  347. Urgent Safety Notice for the device Alaris® SmartSite® Needle-Free Valve, CareFusion
  348. Urgent Field Safety Notice for VENTANA anti-ALK by Roche Diagnostics GmbH
  349. Recall of the PET Esophageal and Pyloric/Colonic Balloon Dilators from ConMed
  350. Safety Notice for Ascendra Balloon Catheter Loader Assembly, Edwards Lifesciences Services…
  351. Safety Notice for the EVG Videogastroskop ENDOMED-DUO and EVC 21-37 Videocoloskop…
  352. Batch Recall for Heparin Adsorber, B.Braun
  353. Urgent field safety notice for ADVIA Centaur XPT, Siemens Healthcare Diagnostics GmbH
  354. Urgent Field Safety Notice for Figulla Flex II ASD by Occlutech GmbH
  355. Cardiac Science recalls the Powerheard AED G3s
  356. Recall of MEDAP connection tubes for medical gases, Maquet
  357. Corrective action for Scorpio Notch Preparation Guide, Stryker
  358. Recall for certain VSII-Laparoscope Integrated 0 Deg Cameras, Visionsense
  359. Safety Notice for two Pedicle Awls, DePuy Synthes
  360. Baxter recalls the infusion set 6060 with 100 ml or 250 ml pre-attached bag
  361. Information concerning the Gettinge/ARJO Flusher Disinfectors, Model SP1000 “undertable…
  362. Recall for several reagents, Becton Dickinson
  363. Problem with AXIOM Aristos system VB10 software from Siemens
  364. Recall for Restoration Modular cone Bodies, Stryker
  365. Urgent Field Safety Notice for LABGEOPT Renal Test 6, Samsung Electronics
  366. Field Safety Notice concerning a corrective action of the spring-loaded arms of the…
  367. Recall of the NexGen® Complete Knee Solution Posterior Referencing Instruments, Zimmer…
  368. TheraSelect recalls the Altair 16G
  369. Recall of the Self Inflating Retrograde Cardioplegia Cannula from Surge Medical Solutions
  370. Recall for the NexGen® Complete Knee Solution PRI - Femoral and Provisional…
  371. Recall for the Velocity Biopsy Valve, US Endoscopy
  372. Recall for VNS Therapy® Model 250 Programming Software, Cyberonics
  373. Safety Notice for the 4D Integrated Treatment Console, VARIAN medical systems
  374. Recall of one lot of the cardiovascular shunt Coroflex Blue Neo, B. Braun
  375. Urgent field safety notice for Unyvero BCU blood culture (Propionibacterium acnes)…
  376. Recall for Dyonics Power Keyless Chuck, Smith & Nephew
  377. Recall of the Inserter for Titanium Elastic Nails (TEN), DePuy Synthes
  378. Information about iPlan RT Dose and VARiS, BrainLAB AG
  379. Urgent Field Safety Notice for CFF05 5x75mm Kii Fios Advanced Fixation Access Sys by…
  380. Information for Disinfection Block inside the 5008 and 5008S dialysis machines, Fresenius…
  381. Safety Notice for WaveLight EX500 Excimer Laser, Alcon Pharma GmbH
  382. Safety Notice for Shear Valve Assembly, used on CELL-DYN analysers, Abbott
  383. Recall of the Gynecare Prolift Pelvic Floor Repair Systems (Outer Product Code: PFRT01)…
  384. Urgent field safety notice for SynchroMed II Implantable Drug Infusion Pump, Medtronic
  385. Urgent Field Safety Notice for Bard TruGuide Disposable Coaxial Biopsy Needles, Bard…
  386. Urgent Field Safety Notice for B·R·A·H·M·S uE3 KRYPTOR by Brahms GmbH, part of…
  387. Recall of the AxSYM Total-β-hCG Reagents, the AxSYM Total-β-hCG Reagents, the IMx…
  388. Urgent Field Safety Notice for Monaco RTP System by IMPAC Medical Systems, Inc.
  389. Urgent Field Safety Notice for Specific IgG4 ELISA by Dr. Fooke-Achterrath Laboratorien…
  390. Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy
  391. Recall of FalcorGent Triglyceride from Menarini
  392. Safety Notice for Synthes Handle, flexible, Synthes GmbH
  393. Safety Notice for Molift Smart 150, Molift Group AS
  394. Safety Notice for HeartStart MRx monitor/defibrillators, Philips
  395. Safety Notice for the product LIAISON® Calprotectin, DiaSorin
  396. Information for ABL8x7 Flex, Radiometer
  397. Recall of the Linvatec 300 Watt Xenon Light Source
  398. Recall of the S8 flow generators from ResMed
  399. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
  400. Recall for Uniglide Unicondylar Knee, Corin
  401. Recall for Obturator 6,5mm x 72mm, cannulated, Smith&Nephew
  402. Lot Recall for R2 Multifunction Electrodes, ConMed Corporation
  403. Recall of all lots of T.E.S.S. Glenoid Anatomic Polyethylene Inlay, Biomet
  404. Safety Notice for the DePuy S-ROM Noiles Rotating Hinge Femur with Pin
  405. Urgent Field Safety Notice for Parietex Hydrophilic Anatomical Mesh by Sofradim…
  406. Information for ICD-models VITALITY HE, RENEWAL 3 and 4, Boston Scientific
  407. Information concerning the Nanoduct sweat test system from WESCOR
  408. Information for AMO™ WHITESTAR SIGNATURE and AMO™ 20 GA, Advanced Medical Optics
  409. Recall for all Maxy Sky 1000/V10 bariatric ceiling lifts, Arjo Huntleigh
  410. Urgent Field Safety Notice for SOMATOM ... several types with Somaris 5 by Siemens…
  411. Lot Recall of the dialysis blood tubing systems BL148 SN, BL211B SND and BL130PSN, Gambro
  412. Field Safety Notice concerning the TeslaPlus MRI-compatible patient monitor, Mammendorfer…
  413. Safety Notice for syngo Imaging, Siemens Healthcare
  414. Safety Notice for the mobilizer Medior, Reha & Medi Hoffmann GmbH
  415. B.Braun AG recalls Intradyn Tear Away Introducer Sheaths
  416. Safety Notice for Coulter Ac•T™5diff Auto Loader Hematology Analyzer, Beckman Coulter
  417. B.Braun recalls Corodyn right heart catheters
  418. Information concerning the iPlan RT Dose 3.0, iPlan RT Dose 3.0.1 und iPlan RT Dose 3.0.2…
  419. Recall for Trabecular Metal Acetabular Revision System Buttress Augments and Trabecular…
  420. Curved Reinforced Tracheal Tubes - Various
  421. Brilliance UTI Clarity Agar
  422. Alaris Syringe Pumps All Models (CC, GH, GS, PK, TIVA)
  423. Correktive actions for Revolution XR/d and Definium 8000, GE Healtcare
  424. Safety Notice for iPulse™ Circulatory Support System console, ABIOMED
  425. Recall for Mesomark Kits, Fujirebio Diagnostics
  426. Corrective action for els Flow Tips, Saremco Dental AG
  427. Urgent Field Safety Notice for Cascadion S. Clinical Analyzer by Thermo Fisher Scientific…
  428. Recall of Dade Behring for Fibrin(ogen) Degradation Products Detection Sets
  429. Information for Definium 8000, GE Healthcare
  430. Recall for ACCU-Flo CSF-Reservoir and HOLTER Rickham Reservoir, Codman & Shurtleff Inc.
  431. DePuy Orthopaedics recalls polyethylene tibial inserts
  432. Safety Notice for Licox® Oxygen Catheter micro-probes, GMS
  433. Urgent Field Safety Notice for SOMATOM ... verschiedene Typen mit Somaris 5 by Siemens…
  434. Urgent Field Safety Notice for Sensis, Sensis Vibe Combo, Sensis Vibe Hemo by Siemens…
  435. Correktive actions for c-arms OEC, GE Healtcare
  436. Safety Information for AMPLILINK 3.2.2 software , Roche Diagnostics
  437. Safety Notice for BD Microlance 30G Needles placed in Beaver-Visitec CustomEyes Kits…
  438. Field Safety Notice for Implantable Cardioverter Defibrillators EnTrust and EnTrust…
  439. Urgent Field Safety Notice for AMICA-GEN by HS Hospital Service S.p.A.
  440. Urgent field safety notice for ExacTrac Vero 3.5.0 - 3.5.3, Brainlab AG
  441. Urgent Safety Notice for the power cords of the respiratory therapy devices Trend II…
  442. Recall of the Lactosorb Air Activated Heat Packs from Biomet
  443. Safety Notice for CTL Array, Body Flex (M), and Body Flex (L) coil with GE Signa OpenSpeed…
  444. Safety Notice concerning communication protocol of Oncentra Simulation, Nucletron B.V.
  445. Urgent Field Safety Notice for ID-DiaCell´s by DiaMed GmbH
  446. Urgent Field Safety Notice for Single Use Guide Sheath Kit by Olympus Medical Systems…
  447. Guidant recalls Peel Away Introducer Sheaths
  448. Safety Notice for Animas 1200 and 2020 insulin pumps, Animas Corporation
  449. Safety Notice for the product syngo Dynamics with Sensis integration licence, Siemens…
  450. Information for GALAXY system, LAP GmbH
  451. Lot Recall for LARGE QWIX screws, Newdeal
  452. Urgent Safety Notice for the device Inspiration Cot 9003, Sidhil Limited
  453. Recall of Stoma support ring KR-XX, Koring AG
  454. Battery depletion of the Elamedical ICD Alto
  455. Product Bulletin for ISKD - Intramedullary Skeletal Kinetic Distractor, ORTHOFIX
  456. Urgent Field Safety Notice for Calcium CA3871 by Randox Laboratories Ltd
  457. Problems with the ViewForum release 3.4L1 from Philips
  458. Recall of the Pivot™ Steerable Microcatheters from Boston Scientific
  459. Corrective action for vancomycin, valproinic acid and tobramycin tests on Cobas C501 and…
  460. Recall of syringe 100 ml with catheter tip and Luer adapter, Fuhrmann GmbH
  461. Lot Recall for BLAKE® Silicone Drains, BLAKE® Silicone Drain Kits, BLAKE® Cardio…
  462. Safety Notice for the Auxiliary O2 & Suction module/Flow-i Anaesthesia system, MAQUET…
  463. Urgent field safety notice for Völker 2080 / 2082 / S 280 / S 282 beds, Hill-Rom
  464. Lot recall of TS100S Diego Elite Tubeset Standard / TS101DC Diego Elite Tubeset Declog…
  465. Safety Notice for ARTISTE MV, Siemens
  466. Recall for Pump Hoses XD 2020, Ulrich medical
  467. Urgent field safety notice for On-Board Imager with CBCT, Varian Medical Systems
  468. Lot recall of Menicon soft 72, Menicon Co. Ltd.
  469. Recall of Dade Behring for the Dimension clinical chemistry system - RCRP (DF34) Flex
  470. Recall of the Cord Clamp Clippers from Unomedical
  471. Safety Notice for the PICTOR 3D multicolour system, LAP GmbH Laser Applikationen
  472. Urgent Field Safety Notice for Medtronic MiniMed Paradigm Infusion Pumps; Medtronic…
  473. Recall of the Dräger anaesthesia masks ComfortStar from Dräger
  474. Lot recall of STADA diagnostic H.pylori self-tests, MEXACARE GmbH
  475. Safety Notice for the Cell Dyn Sapphire System, Siemens
  476. Corrective action and recall of Sysmex and Dade Behring for Sysmex CA-1500, CA-7000 and…
  477. Recall Smash™ Balloon Dilatation Catheter, Boston Scientific
  478. Field Safety Notice from Aesculap AG to the importance of routine inspection of the…
  479. Lot Recall of the port needle B-20302-10, Allergan Medical
  480. Recall for Medtronic U-clip V100D Approximation Device, Medtronic
  481. Corrective action for the RIO® Robotic Arm Interactive Orthopedic System, MAKO Surgical…
  482. Urgent Field Safety Notice for Cardio M plus by Medical Econet GmbH
  483. Corrective action for iChem Velocity Urine Chemistry Strips, Iris International
  484. Information for Incidin rapid, Ecolab
  485. Urgent Field Safety Notice for Endothelmikroskop I Specular Microscope CEM-530 by NIDEK…
  486. Boston recalls the Extractor Retrieval Balloon Catheter
  487. Recall for SYNCHRON Systems Ammonia (AMM) Reagent, Beckman Coulter
  488. Safety Notice for NovaFlex Introducer Sheath Sets, Edwards Lifesciences

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