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International device safety notices

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

  1. Recall of the Durasul Alpha Insert Box from Zimmer
  2. Recall for the Knot Pusher, Arthrocare
  3. Safety Notice for MiniCaps with Povidone-lodine, Baxter
  4. Urgent Field Safety Notice for UNIMED Medical Needle by UNIMED S.A.
  5. Urgent Field Safety Notice for Tip Protectors of the bulb syringe, Rocialle
  6. Recall of the Introducer sheath Intradyn Tear-Away F10 from B.Braun
  7. Recall of the Alpha Durasul Inlays from Zimmer
  8. Atrium Medical Cooperation: Recall of Atrium ATS drains
  9. Urgent Field Safety Notice for Access SARS-CoV-2 IgG Quality Control by Beckman Coulter
  10. Corrective action concerning the Integris and Allura Xper X-Ray Systems from Philips
  11. Another Recall for Triathlon Primary Cemented Baseplate, Stryker
  12. Corrective action of the Treatment Planning Systems Eclipse from Varian
  13. Information for ADVIA Centaur Systems HAV IgM assay, Siemens
  14. Corrective action and recall of the ABL800FLEX analyzers from Radiometer
  15. Safety Notice / Recall for TPHA Test kit, Oxoid Ltd.
  16. Safety Notice for the Acetocaustin Pen, Temmler Pharma GmbH & Co.
  17. Recall for High Viscosity Injectors, Beaver-Visitec International
  18. Urgent Safety Notice for the CLINITEK Novus® Analyzer, Siemens Healthcare Diagnostics Inc.
  19. Corrective action of the Treatment Planning Systems Eclipse from Varian
  20. Corrective action for the CLINITEK Novus® Analyzer, Siemens Healthcare Diagnostics
  21. Advisory notice for Cook Frova Airway Intubating Catheters
  22. Corrective action for the ADVIA Chemistry Systems Drug Calibrator I, Siemens Healthcare…
  23. Information for Masimo Rad-8 device, Masimo
  24. Urgent Safety Notice for the LANTIS™ Oncology Information System Server, Siemens AG
  25. Recall of GreenLight HPS™ 0010-2090 Laser Fibers, AMS
  26. Safety Notice for "Platon ti" Femoral Nail, TANTUM
  27. Urgent field safety notice for ventilator STEPHANIE, Fritz Stephan GmbH
  28. Urgent Field Safety Notice for NucliSENS Lysis Buffer by bioMérieux S. (Marcy- l'Etoile)
  29. Corrective action of Biomerieux for BacT/Alert® and BacT/View® systems
  30. Safety Notice for ARTISTE-Linear Accelerator, Siemens
  31. Corrective action of Panbio Limited for Dengue-Duo Casette Kits
  32. Urgent Field Safety Notice for ECLIPSE 2L by BALT Extrusion
  33. Recall of Dynesys Universal Spacer from Zimmer
  34. Safety Notice for MicroCal Software, Medtronic
  35. Hardware updates required for Discovery NM/CT 670 SPECT/CT and Discovery NM 630 SPECT…
  36. Recall for the ceramic Biolox delta Insert, Aesculap AG
  37. Wiliam Cook Europe recalls the Osteo-Site Bone Biopsy Needle Set
  38. Recall for Cardio Life Research MitraXs Self Adjusting Atrial Retractor, St. Jude Medical
  39. Corrective action for Thermo Scientific MAS® Omni Immune™ and MAS® Omni Immune™ Pro…
  40. Recall ABL700/ABL800 analyzers, Radiometer
  41. Recall for Coagulation Factor VIII Deficient Plasma (OTXW), Siemens
  42. Recall Aorfix™ Stent-Graft, Lombard
  43. Safety Notice for the product aycan OsiriX, Aycan Digitalsystem GmbH
  44. Recall of the intraocular lenses GBR/ Vivarte Myopic and Newlife/Vivarte Presbyopic from…
  45. Recall of HLA Fusion Version 2.0.0-SP1, One Lambda
  46. Safety Notice for VISIOL® pre-filled syringes, TRB Chemedica
  47. Baxter recalls the Benja-Mix Verlängerungsset
  48. Safety Notice for GE Centricity PACS Software Versions 2.1.x and 3.0.x, GE Healthcare
  49. Recall of LIFEPAK CR® Plus and LIFEPAK EXPRESS® defibrillators from Medtronic
  50. Recall for BD Insyte™ Autoguard™ IV Catheter, Becton Dickinson
  51. Connection Problems with Lifepak 500 defibrillators from Medtronic
  52. Recall for SafeSheath® CSG® Coronary Sinus Guide Hemostatic Introducer System with…
  53. Change in the Instructions for Use of the blood cell separator Amicus form Baxter
  54. Recall for Accu-Chek Inform II Battery Packs, Roche
  55. Corrective Action for Coagulation Factor IX Deficient Plasma, Dade Behring
  56. Recall of several articles and lots of the Anspach® Short Carbide Cutting Burrs, The…
  57. Recall for BD Vacutainer Plastic Sodium Heparin Blood Collection Tube with Green BD…
  58. Safety Notice for iSleep 20+/20i, BREAS
  59. Lot recall of LASEREDGE 1.6 mm x 1.8 mm Trapezoid Angled 6/Box, Valeant Pharmaceuticals…
  60. Corrective action and recall of the Benzodiazepin reagent from Bayer
  61. LinkSeq HLA ABCDRDQA1DQB1/ABCDRDQDP+/SABR/DRDQDP
  62. Brainlab Navigation System Spine & Trauma 3D
  63. Oncor
  64. Medtronic Durepair Dura Regeneration Matrix - tagasikutsumine, ET tasemed
  65. Recall of the Ammonium reagent from Bayer
  66. DePuy Synthes: recall of several Softlock forceps
  67. Corrective action for ACE Control, Trinity Biotech
  68. Safety Notice for the product Synchrony® Boom Arm Mounting Assembly, Accuray
  69. Recall for Legion Press Fit stems, Smith & Nephew
  70. Information for BD Pre Anaesthesia Trays, Becton Dickinson
  71. Urgent Field Safety Notice for Urea by Thermo Fisher Scientific Oy
  72. Recall TOPS and TOPS-on-Fusion System, MedNet
  73. Information for Coonrad/Morrey Total Elbow System, Zimmer
  74. Urgent field safety notice for NucliSENS easyMAG and eMAG silica, bioMérieux SA
  75. LeMaitre Aortic Occlusion Catheter - tagasikutsumine, teavitatud asutusega kooskõlastamata…
  76. Becton Dickinson recalls the Probe Tec Urine Processing Kit
  77. Urgent Field Safety Notice for Lifepak 15 by Physio-Control, Inc.
  78. Recall of the dual chamber C- and T-series pacemakers from Vitatron
  79. Urgent Field Safety Notice for Merlin@Home Transmitter by St. Jude Medical, Cardiac Rhythm…
  80. Urgent Field Safety Notice for MMI-AMTS-Service by Vidal MMI Germany GmbH
  81. Corrective action and recall of Sysmex for SF-3000 Haematology Analyzer
  82. Recall for Genesis II Long Stem, Smith & Nephew
  83. Lot recall for SIGMA High Performance (HP) MBT Non-Keel Punch Knee Instrument, Johnson &…
  84. Urgent Field Safety Notice for ThermaCare by Pfizer Consumer Health Care
  85. Urgent Field Safety Notice for OntoDrug AMTS by Vidal MMI Germany GmbH
  86. Recall for Compass PIP Hinge, Smith & Nephew
  87. Recall for SilverHawk Cutter Driver, ev3
  88. Batch Recall of ELS Syringes, PEROUSE MEDICAL
  89. Urgent Field Safety Notice for Cortisol Saliva Luminescence Immunoassay by IBL…
  90. Urgent Field Safety Notice for Mindray patient monitors by SHENZSHENZHEN MINDRAY…
  91. Information about Elisee 250 and Elisse 350 from ResMed
  92. Safety Notice for UniCel DxC 880i Synchron Access Clinical Systems, Beckman Coulter
  93. Updated Safety Notice for the PLEGIOX Cardioplegia Heat Exchanger, Maquet
  94. Safety Notice concerning user instructions for laser device Dornier Medilas D UroBeam…
  95. Field Safety Notice concerning Patient Image mismatch and incorrect…
  96. Genzyme Virotech recalls the IgA Cut-off controls of the Yersinia enterocolitica EcoBlot
  97. Information concerning the Vbeam / Aesthetica, Platinum and Perfecta model laser systems…
  98. Recall for Pronto-7 Rainbow 4D reusable Sensor, Masimo
  99. Safety Notice for XVI R3.5, R4.0, R4.2, and R4.5, Elekta
  100. Corrective action of the Vitek GPS-531, Vitek GPS-532 and Vitek GPS-533 cards for…
  101. Safety Notice concerning a corrective action of the BeneHeart D6 defibrillator/monitor…
  102. Recall of manual hand crank on the manual drive for Sarns™ Modular Perfusion Systems 8000…
  103. Urgent Field Safety Notice for MultiDiagnost Eleva IITV & MultiDiagnost Eleva FD by…
  104. Biotest recalls the Anti-Jsa Reagent
  105. Recall of LigaSure Atlas™ instruments from Tyco
  106. Field Safety Notice for Hemoglobin Denaturant OSR0004, Olympus
  107. Field Safety Notice concerning development of granuloma at intrathecal catheter tips of…
  108. Urgent field safety notice for product / detection kit combinations, Leica Biosystems…
  109. Recall for Model 515A Oxygen Concentrator, DeVilbiss
  110. Safety Notice concerning TiBREEZE breast implants, pfm medical titanium GmbH
  111. Corrective action of the RD/Hitachi 902/904/911/912, RD Hitachi/917 Modular P and Modular…
  112. Recall Trident® Acetabular cups, Stryker
  113. Safety Notice: Corrective Action for Meducore Easy, Weinmann Geräte für Medizin GmbH + Co…
  114. Recall for 30/40/50 CC IAB Catheters - IAB Volume Connectors, Teleflex Medical
  115. Information for C-series Ximatrons, Varian
  116. Problems with Somatom computer tomographie scanner from Siemens
  117. Updated Instructions for Use (IFU) for the Zenith Alpha™ Thoracic Endovascular Graft, Cook…
  118. Urgent field safety notice for INNOVANCE D-Dimer on Sysmex CS-2000i / 2100i / 2500 / 5100…
  119. Field safety notice concerning incorrect position readout values, Varian medical systems
  120. Lot Recall for Ostim 35, aap Biomaterials
  121. Safety Notice: Instructions for Use Modification for VASOVIEW HEMOPRO Endoscopic Vessel…
  122. Safety Notice for Aquarius RCA GEF09500, Edwards
  123. Urgent field safety notice for Eclipse Treatment Planning System, Varian Medical Systems
  124. Final rinse water of Endothermal Disinfectors from Miele was found to contain residual…
  125. Potential malfunction when using syngo.plaza VA20B_HF04, Siemens Healthcare
  126. Additional important Information about CEM™ Nosecones for use with CUSA® Excel/Excel+…
  127. Lot recall of Bravo pH Monitoring devices, Given Imaging
  128. Corrective action of Roche for Unimate 3 HbA1c and Unimate 5 HbA1c
  129. Safety Notice for the device Coulter®PrepPlus 2-Systems, Beckman Coulter
  130. Corrective action for ABX Pentra ML, Horiba ABX
  131. Corrective action for ACON On Call® Advanced Blood Glucose Monitoring System, ACON…
  132. Corrective action of the cards for susceptibility testing for the analyzers Vitek, Vitek 2…
  133. Corrective action of the Elekta Synergy linear accelerator from Elekta Oncology Systems
  134. Urgent Field Safety Notice for systems ADVIA Centaur / Dimension Vista / IMMULITE, Siemens…
  135. Lot Recall of a single use surgical drape, Mölnlycke Health Care
  136. Recall of the Quantum Biliary Dilation Catheter from Cook Endoscopy
  137. Recall of the BD Procount Kit with lot number 65857 from Becton Dickinson
  138. Safety Notice concerning T-Pieces, Intersurgical
  139. Recall of Certain® low profile 17° angled abutment, BIOMET 3i
  140. Safety Notice for MultiPlan® Treatment Planning System, Accuray
  141. Recall of VAD Dual Drive Consoles from Thoratec
  142. Recall for AQC cartridge - Rapidlab 1245 and 1265 systems, Siemens
  143. Y Tubing Set - 10/BX 9'
  144. TRUMPF recalls the Head Rest for Shoulder Operation
  145. Information for DePuy DNP Anatomic Fracture Repair System, DePuy
  146. Recall Optifine™ cannula, Ypsomed
  147. Urgent field safety notice for Küschall® manual wheelchairs Advance / Champion / Compact /…
  148. Security gap in the control software of cleaning and disinfection machines type WD 280…
  149. Recall Pectus Table Top Bender, Biomet
  150. Urgent Field Safety Notice for GASTROINTESTINAL VIDEOSCOPE / COLONOVIDEOSCOPE by Olympus…
  151. Recall for BHR Bridging Cup 66 mm, Smith & Nephew
  152. Recall of the 200ml ELS Syringe for contrast media injector, Medtron AG
  153. Recall for the product "Bauchtuch-Set weiß und steril", Fuhrmann GmbH
  154. Urgent Field Safety Notice for RIDA QUICK Malaria Control by R-Biopharm AG
  155. Information concerning the mobile lifts Uno and Sabina from Liko
  156. Field Safety Notice for AxSYM Amphetamine/Methamphetamine II assay file, Abbott
  157. Recall for Weber Medullary Plug, Zimmer
  158. Lot recall of SWiTCH Needle-Protected Safety Catheter, VIGMED AB
  159. Failure in XVI, Elekta
  160. Safety Notice for the LOCATOR® Implant Attachment Systems, Zest Anchors LLC
  161. Urgent Field Safety Notice for Medonic M-Series/M32 Autoloader with Automatic Barcode…
  162. Recall / Safety Notice for Stryker Femoral Sponges, Stryker
  163. Urgent Safety Notice for Precedence and SKYLight Spect Systems, Philips
  164. Recall of the Hydrocephalus Shunt Burr Hole Valve from Integra Neuroscience
  165. Recall of the Guardian™ Hemostasis Valves from Zerusa
  166. Safety Notice for Centricity™ PACS RA1000 Workstation Software, GE Healthcare
  167. Corrective action for Immulite 2000 and Immulite 2000 XPi Osteocalcin, Siemens
  168. Electro Medical Systems recall Ultrasonic Handpieces
  169. Information for OmniDiagnost Eleva, Philips
  170. Safety Information for COBAS AmpliPrep R-Tips, Roche
  171. Safety Notice for Cordis Sleek® OTW PTA Dilatation Catheter, ClearStream Technologies
  172. Additional resistor at TRAC 3000 MED from Ergofit
  173. Recall for HA ABG II and HA DLS Hip Stems, Stryker
  174. Urgent Safety Notice for the device VERO™ Linear Accelerator System, Mitsubishi Heavy…
  175. Urgent Field Safety Notice for IntelliVue Patient Monitors, Philips Healthcare
  176. Recall Dimension clinical chemistry system Urea Nitrogen (BUN) Flex reagent cartridge…
  177. Recall of all Alcohol pads and swabsticks (sterile and non-sterile), h&w cv
  178. Field Safety Notice concerning automated external defibrillators Powerheart, Cardio Vive…
  179. Corrective Action for primary antibodies to CD2 and CD7, Leica Biosystems
  180. Recall of the eye drops Visine Intensive, Visine Tired Eyes and Visine Tired Eyes…
  181. Batch recall of LEGION Screw-On Hemi Stepped Tibial Wedges, Smith & Nephew Inc. / S&N…
  182. Urgent Field Safety Notice for Oxoid Streptococcal Selective Agar C.O.B.A by Thermo Fisher…
  183. Urgent Field Safety Notice for INNOTERE Paste-CPC, VELOX, Calcifix by InnoTERE GmbH
  184. Recall of the PI-128 Intraducer Peritoneal Catheter from TAUT
  185. Corrective action for Omni C, Omni S, cobas b 121 und cobas b 221, Roche
  186. Urgent Field Safety Notice for Atellica IM 1300 and IM 1600 Analyzers by Siemens…
  187. Abbott recalls the QIAamp Viral Nucleic Acid Extraction Kit
  188. Urgent Field Safety Notice for Surgical Clipper Charger by Medline Industries Inc.
  189. Recall of FF013P Scalpfix clamps from Aesculap
  190. Recall of the lot number A06J02257 of the Amicus Apheresis Set (R4R2340) from Baxter
  191. Information for System 1000 and Arena Hemodialysis Instruments, Baxter
  192. Preventive actions for syringe pumps type Module DPS, Fresenius Vial
  193. Safety Notice for Precise Treatment Table, Elekta
  194. Safety Notice for PEGA® TUBE, Venner Medical (Deutschland) GmbH
  195. Safety Notice for Axiom Artis systems, Siemens
  196. Corrective action for SURE on BEP III System, Dade Behring
  197. Urgent field safety notice for Eclipse Injection Needle, Eclipse Injection Needle with…
  198. Recall of the StarClose Vascular Closure Systems from Abbott
  199. Urgent Safety Notice for the Crystalens® AO Intra Ocular Lenses, Bausch + Lomb Surgical…
  200. Corrective action for ABL80 FLEX Analyzers configured with either FLEX or BASIC software…
  201. Urgent field safety notice for VIDAS 3 software v1.1.4, bioMérieux
  202. Risk when using the Infusion Pump µVP7000 from Arcomed
  203. Recall M-Style Mushroom Cup Mity Vac / Mystic II, Cooper Surgical
  204. Boston Scientific recalls WallFlex™ Enteral Duodenal Stents
  205. Recall of BSS DeltaSelect from DeltaSelect
  206. Urgent Safety Notice for CADD®-Solis Pumps, Smiths Medical
  207. Lot recall of Accolade Rasp handle assembly, Stryker Orthopaedics Mahwah
  208. Recall orthodontic wire, Highland Metals
  209. Urgent Field Safety Notice for Rusch GreenLite MAC (diverse Größen) by Teleflex Medical…
  210. Corrective Action for EVOLUTION® Tibial Base, MicroPort Orthopedics
  211. Lot Recall of the umbilical cordclamp, model 0816, Intersurgical Beatmungs-Produkte
  212. Corrective action for Monnal T50 ventilators, Air Liquide Medical Systems
  213. Upgrade of the instruction for use of the fixing of tightening strap model 460 in…
  214. Recall dental implant closure screws, Institut Straumann
  215. Recall of Stryker Arthroscopic 5.5 mm Bur
  216. Software update of Cardiofax V ECG-units from Nihon Kohden
  217. Corrective action for the neon3™ Crosslinks, ulrich GmbH & Co. KG
  218. Urgent field safety notice for BK Virus R-gene Kit, bioMérieux SA
  219. Urgent Field Safety Notice for Getinge 88-series by Getinge Disinfection AB
  220. Urgent Field Safety Notice for Revolution Apex, Revolution CT by GE Medical Systems LLC
  221. Corrective Action for clinical Chemistry Analyzers AU2700 / AU2700 Plus and AU5400…
  222. Update of cardioPAT® Manual for Leak Detection, Haemonetics
  223. Safety Notice for VentrAssist LVAD Model LVA4 VA166 Blood Pump, Ventracor
  224. Recall of Colorado 2 Anterior Plates from Medtronic
  225. Recall patient lift Arnold with calibrated scale PW300, REBOTEC
  226. Safety Notice concerning a corrective action of the defibrillator/pacer SLIM unit, part of…
  227. Urgent Field Safety Notice for Höhenverstellbarer Trainingstisch 43- 64 cm by FREI AG…
  228. Information about the exchange of self-sealing screws at the Performix Pro X-Ray Tube used…
  229. Corrective action for the GORE® TIGRIS® Vascular Stent, W. L. GORE & ASSOCIATES, INC.
  230. Urgent Field Safety Notice for Affinis Inverse Glenosphäre 39 mit Fixationsschraube by…
  231. Safety information for the emergency carriage Calypso and Calypso GT Plaster Table from…
  232. Recall for Compat Go Giving Sets, Nestlé Healthcare Nutrition GmbH
  233. Urgent Field Safety Notice for INNOVANCE DTI by Siemens Healthcare Diagnostics Products…
  234. Safety Notice for Extended Brilliance Workspace, Gemini and PET Apps Suite, Philips
  235. Software upgrade of hemodialysis machine Formula 2000 from Bellco
  236. Recall of TriGen InterTan from Smith & Nephew
  237. Urgent field safety notice for Puritan Bennett 980 Series Ventilator System, Covidien…
  238. Information for ICONOS R200 ND, Siemens
  239. Safety Notice for Radiolucent Spine Reference Clamp, BrainLAB
  240. Corrective Action for TCAutomation/enGen Laboratory Automation Systems, Thermo Fisher…
  241. Urgent Field Safety Notice for Traverse Rail Carrier by Liko AB
  242. Corrective action for Advia 1800 und Advia 2400 ISE Firmware V2.23, Siemens
  243. Urgent Field Safety Notice for Ziehm Vision RFD; Vision RFD 3D; Ziehm Solo FD by Ziehm…
  244. Urgent Field Safety Notice for Deconex by Borer Chemie AG
  245. ARKOPHARMA Heilerde Plv Btl15 Stk / ARKOPHARMA Argile pdr sach 15 pce
  246. PERCUQUICK ONE-STEP DILATOR
  247. COULTER® HmX Hematology Analyzer
  248. Ysio Max
  249. Roche Elecsys CA 19-9 - mittereprodutseeritavate kõrgenenud väärtuste suurem määr
  250. Roche Diagnostics cobas t511 ja t711 koagulatsiooni analüsaator - PT Rec faktortestide…
  251. Software update for Leica M822 F20 and M822 F40 surgical microscopes required, Leica…
  252. Advisory Notice concerning syngo Imaging XS, Siemens Healthcare
  253. Urgent Field Safety Notice for Senographe Crystal Nova by GE ULTRASOUND KOREA, LTD
  254. Information concerning the syngo Cardiac Echo Quantification feature in syngo Dynamics…
  255. Corrective action for ADVIA Chemistry Systems, Siemens
  256. Safety Information concerning VS III ventilators, ResMed
  257. Recall for the VA-LCP Distal Radius Plate, SYNTHES
  258. Urgent Field Safety Notice for 3D Optical Coherence Tomography by Topcon Corporation
  259. Recall Accu-Chek Inform, Roche
  260. Recall of Medtronic Devon Light Gloves (Light Handle Covers), ArcRoyal
  261. Safety Notice for the SEVEN and SEVEN Plus Continuous Glucose Monitoring Systems, Dexcom…
  262. Lot / batch recall of Bohrloch Reservoir-Set, Christoph Miethke GmbH & Co. KG
  263. Insulin pumps with accessories: insulin pump MiniMed 640G
  264. Safety notice for roller pump, Arthrex
  265. Recall for MOST® Hinged Tibia Baseplate Spacer, Zimmer
  266. Urgent field safety notice for Revitan straight and curved distal stems, Zimmer Biomet /…
  267. Urgent Field Safety Notice for Intera, Enterprise, Achieva, Achieva XT, Achieva C by…
  268. Safety instruction for the usage of ZMM 2000 Zeppeling Motordrill System
  269. Field corrective action regarding the MIS Anterolateral Instrument Sets from Zimmer
  270. Recall for CADD™ Medication Cassette Reservoir, Smiths Medical
  271. Serumwerk recalls the SN-connector
  272. Risk with the PRISMA 2 K from Siemens
  273. Urgent Field Safety Notice for Olympus Evis Exera Pleura Videoscope LTF-160 by Olympus…
  274. Smiths Medical MD reminds in a Safety Alert about problems with the CADD-Legacy® 1 or…
  275. Recall of the Select 3D™ and Select CAP™ Arterial Cannula product families, Medtronic
  276. Recall of all Balanced Salt Solutions (BSS) form the manufactuer Cytosol Laboratories Inc.
  277. Urgent Field Safety Notice for NATURA LP57 HCA DURA CVXCTF13-35 1X5EUR by ConvaTec Limited…
  278. Safety Notice for the Super MultiVac 50 Coblation Wands, Arthrocare
  279. Urgent Field Safety Notice for BD Phoenix GramNegative Panels containing Colistin by…
  280. Urgent Field Safety Notice for Software für Immunomate by Institut VirionSerion GmbH
  281. Recall of Active Renin IRMA Test Kit, Beckman Coulter
  282. Updated Important Safety Notice for the Apex™ collimator, Elekta
  283. Medtronic recalls Exponent RX Self-Expanding Stent Systems
  284. Corrective action of Dade Behring for the Sample Uniformity Recognition Module of the BEP
  285. Recall of defined lot numbers of RF denervation probes from Smith & Nephew
  286. Urgent Field Safety Notice for Spectra Optia System by Terumo BCT, Inc
  287. Recall of Dade Behring for Test Thrombin Reagent
  288. Corrective action for TruCal Apo A1 (Lot-No. 13785 - 13787), DiaSys
  289. Recall Fogarty occlusion catheters, Edwards Lifesciences
  290. Urgent Field Safety Notice for T-Cell Select by Oxford Immunotec Ltd.
  291. Informationen for VariantTM Hemoglobin Testing System, BIO-RAD
  292. Recall MIH Mod Cup Inserter, Biomet
  293. Lot Recall for QWIX Bone Screws, Newdeal
  294. Urgent Field Safety Notice for AGILON glenoid components by implantcast GmbH
  295. Corrective action for Lactat-PAP, DiaSys Greiner
  296. Urgent Field Safety Notice for DORC Directional Laser Probe by D.O.R.C. Dutch Ophthalmic…
  297. Information for the Accu-Chek Combo insulin pump, Roche Diagnostics Deutschland GmbH
  298. Urgent Field Safety Notice for PHYSICA TT TIBIAL PLATES by LIMACORPORATE S.P.A.
  299. Lot recall of Bicontact Revision Stem, Aesculap AG
  300. Recall of all Otto Bock Aerial and Aerial Active Wheelchair Cushions, Otto Bock
  301. Urgent Field Safety Notice for T34 syringe pump by Caesarea Medical Electronics Ltd.
  302. LOT's: see letter
  303. Corrective Action for Paraffin Pretreatment Reagent Kit II and Paraffin Pretreatment…
  304. Safety Notice for the product Oncentra® Simulation v2.X, Elekta
  305. Corrective action for Clinical Chemistry Phosphorus of Abbott
  306. Safety Notice for Powerheart 9300A, 9300E, 9300P, 9390A, 9390E and Responder model…
  307. Recall for Orthocord Suture, DePuy Mitek
  308. Urgent Field Safety Notice for Optima Coil System, Prestige Coil System by BALT USA LLC
  309. Urgent Field Safety Notice for Telescopic Smoke Evacuation Pencil by LiNA Medical ApS
  310. Retrofitting of the lamps for phototherapy model Actilite from Photocure ASA
  311. Information for NobelDirect and Nobelperfect, Nobel Biocare
  312. Corrective Action for SYNCHRON LXi 725 and UniCel DxC 600i Systems, Beckman Coulter
  313. Recall of oleandomycin test disks, Oxoid
  314. Recall G3 Set Screwdriver, Stryker
  315. Recall for Hydrolift insertion instrument with Hydrolift hydraulic pipe, Aesculap AG
  316. Safety Notice for several Combi-Sets, containing BD™ Plastipak 50ml Luer Lok Syringes…
  317. Safety Notice regarding device TomoTherapy® Treatment System, ThomoTherapy Incorporated
  318. Recall of Beckman Coulter for Access Immunoassay Systems Digoxin reagent
  319. Information for Centricity RIS Software Version 4.Xi/Web Order-Option, GE Healthcare
  320. Recall of various products packaged in Tyvek Pouch, Conmed Linvatec
  321. Corrective action of Roche for Accu-Chek Sensor Comfort test strips
  322. Safety Notice for Sireskop SX and AXIOM Sireskop SD, Siemens
  323. Recall of Hema Technologies for Bilirubin Stat and Bilirubin Plus analyzers
  324. Corrective action for the MRI systems with superconducting magnets, GE Healthcare
  325. Recall for Genesis II Femoral Components, Smith & Nephew
  326. Corrective action of BioMerieux for BacT/Alert subculture units
  327. Corrective action and recall for the enGen Laboratory Automation System, Ortho
  328. Urgent Field Safety Notice for HLM tubing set by HMT Medizintechnik GmbH
  329. Safety Notice: Update of the Implant Extraction Set Brochure, Stryker
  330. Safety Notice for Gliding Nail Blade Handle, SMITH&NEPHEW
  331. Arrow recalls the Stimu-Cath Continous Nerve Block needles
  332. Safety Notice for TREVO Retriever, Concentric Medical Inc.
  333. Recall of ATB ANA EU Kit, BioMerieux
  334. Corrective action for AXIOM ARTIS systems, Siemens Healthcare
  335. Expanded Recall for the products Lapra-TY™ II Clip, PDS™ II, Vicryl™, Vicryl™ Plus…
  336. Urgent Field Safety Notice for different Certain BellaTek Encode Healing Abutments by…
  337. Urgent Field Safety Notice for Locking Cortical Screw, No.-Locking Hexalobe Screw by…
  338. Recall for Grafix Tendon Stripper, ConMed Linvatec
  339. Corrective action for COULTER PrepPlus, Beckman Coulter
  340. Urgent Field Safety Notice for AT-102 / AT-102 plus / AT-10 plus /AT-104 PC / AT-104 PC…
  341. Urgent Field Safety Notice for Multiple devices by US Endodontics, LLC.
  342. Corrective action of Biotest for Tango blood group analyzers
  343. CE certificate of conformity of Syneron Dental Lasers LiteTouch temporarily suspended…
  344. Urgent Field Safety Notice for CONTACT AIR spheric by Wöhlk-Contact-Linsen GmbH
  345. Corrective Action of specific Trilogy Ventilators, Philips Respironics
  346. Safety Notice for the CT System SCENARIA / ECLOS, Hitachi
  347. Corrective action for ADVIA Centaur Systems Progesterone Kits, Siemens Healthcare…
  348. Urgent Field Safety Notice for Qstress/Xscribe, Hscribe/Vision Exp, DCS, ConnexCa by Welch…
  349. Urgent field safety notice for hypo- / hyperthermia units, Xenios AG
  350. WaveLight recalls the acrylic intraocular lenses Acriflex 47CSE and 48CSE
  351. Urgent Field Safety Notice for LOGIQ P6 systems by GE Medical Systems Information…
  352. Information for SENSE head coil 8 channel, Philips
  353. Safety Notice for qLabs PT-INR Q-1 Pro Test Systems, nal von minden
  354. Urgent Field Safety Notice for AFFINITY® NT (see comment 1) by Medtronic Inc
  355. Information about the Transseptal Sheath from the company ProRhythm
  356. Urgent Field Safety Notice for 1) MARS Kit Gambro, Type 1112/1 2) MARS kit GAMBRO by…
  357. Information for Edwards SAPIENTM THV, Edwards
  358. Recall for Tessier Osseous Microtome (TOM), Stryker Leibinger
  359. Lot recall of Xpert BCR-ABL, Cepheid
  360. Lot Recall for Vitesse Biopsie Needle, Delta-Cut, 2-part, OptiMed
  361. Recall for Intro-Flex Percutaneous Sheath Introducer, Edwards Liefesciences Services
  362. Levitronix recalls the Levitronix CentriMag VAD European Priming Circuit
  363. Safety Notice for EnRhythm, EnRhythm MRI and Advisa pacemakers, Medtronic
  364. Recall ReNu Comfort Drops, Bausch & Lomb
  365. Recall for Liko Comfort Sling Plus Model 300 - Incorrect strap length, Liko
  366. Safety Notice for ApexPro Telemetry System, GE Healthcare
  367. Safety Notice for the STERRAD® 200 System, ASP
  368. Recall of Covidien Devon Light Gloves and non-sterile sub assembly kits, Medtronic
  369. Recall of Beckman Coulter for UniCel® DxI Access Immunoassay System®
  370. Corrective action of The Binding Site for Minineph
  371. Corrective action and recall of DPC Biermann for Immulite 2000 and Immulite 2500 systems
  372. Amendment of instructions for use of Advansys® Medical Lisfranc Plates, Newdeal SAS /…
  373. Bander Ureteral Diversion Stent Set
  374. Urgent Safety Notice: Recommendation for the surgical technique, Biomet France Sarl
  375. Recall of the product Tiger Tube Self-Advancing Nasal Jejunal Feeding Tube from the…
  376. Field Safety Notice concerning revised instruction for use of mattress model NP 150, Hill…
  377. Recall electrosurgical blades and needles, ConMed Electrosurgery
  378. Safety Notice for Accessory Pack for ROCsafe with Flexible Venous Reservoir, Terumo Europe
  379. Recall for Hemovac Autotransfusion System, Zimmer
  380. Recall for the DynaChip HLA Antibody Analysis System, Invitrogen
  381. Corrective Action for Sysmex CS-2000i/CS-2100i System, Siemens
  382. Recall for NFlex-Rods, Synthes
  383. Safety Notice for Carescape Monitor B850 F5-01 Frame, GE Healthcare Finland Oy
  384. Corrective action and recall of Nova Biomedical for Stat Profile CCX Analyzer
  385. Corrective action for AED 10 defibrillators, Welch Allyn
  386. Problem with the T-mode filming from Toshiba
  387. Safety Notice for MUSE Cardiology Information System, GE Healthcare
  388. Urgent Field Safety Notice for Conductivity sensor spare part for Dialog machines by B…
  389. Recall of the Phadebact CSF Test from Bactus
  390. Urgent Field Safety Notice for OPTIMA COIL SYSTEM by BALT USA LLC
  391. Safety Notice for iLED3, iLED5 and iLED5K Operating Theater Lighting Systems, Trumpf
  392. Expanded Safety Notice for BrightSpeed Excel / Edge / Elite Select and BrightSpeed Elite…
  393. Corrective action of the Giraffe and Panda Resuscitation systems with Blender including…
  394. Urgent Field Safety Notice for VITEK 2 ID / AST Card Types by bioMérieux Inc
  395. Urgent Field Safety Notice for Breelib Starter Pack, Breelib Monthly Pack by Vectura Group…
  396. Recall for femoral saw guides sizes klein/small and mittel/medium for the Endo-Model…
  397. Recall for the Treatment Packs, Carl Zeiss Meditec AG
  398. Urgent Field Safety Notice for SARS-CoV-2 Antigen Test Kit (Colloidal Gold) by Genrui…
  399. Important Information for the Syramed µSP6000 PCA and ANE syringe pumps from Arcomed
  400. Urgent Safety Notice for Axiom Artis or Artis zee systems in connection with hand switch…
  401. Urgent field safety notice for Carina Mobile Lifts, Handicare AB
  402. Urgent Field Safety Notice for CHA Anesthesia and CHA Critical Care by GE Healthcare
  403. Urgent Field Safety Notice for LABGEO HC10 by Samsung Electronics Co. Limited
  404. Recall Hydromax intraocular lens, Carl Zeiss Meditec
  405. VIDAS High Sensitive Troponin I,
  406. Corrective action of Tosoh Bioscience for HbA1c-Control
  407. Safety notice for Orbiter patient transfer system, Trumpf Medizin Systeme GmbH
  408. Software update for implantable drug infusion pumps model 91-4200 and 91-4201, Codman
  409. Lot recall of Accu-Cut Saw Blade AO Drive, Zimmer Biomet UK Ltd.
  410. Urgent field safety notice for LIFEPAK® Defibrillator, Physio-Control Netherlands B.V.
  411. Recall of the contact lens care solutions "ReNu With Moisture Loc" from Bausch and Lomb
  412. Recall Pericardial Sump, California Medical Laboratories
  413. Lot Recall for Z-Med II Percutaneous Transluminal Valvuloplasty Catheters and COEfficient…
  414. Urgent Field Safety Notice for ABL90 FLEX and ABL90 PLUS by Radiometer Medical ApS
  415. Corrective Action for IMMULITE CK-MB, Siemens
  416. Recall of the products TSV 25 Gauge High-Speed Cutter und TSV 25 Gauge High-Speed…
  417. Possible stuck or hard to turn Pump speed control knob, Sorin Group
  418. Urgent field safety notice for dilator and sheath length 460 mm / d 1,7 mm (F5) / with…
  419. Urgent field safety notice for ADVIA Centaur / Dimension Vista / IMMULITE systems, Siemens…
  420. Urgent Field Safety Notice for Multiple Patienten Receiver by Nihon Kohden Corp.
  421. Urgent Field Safety Notice for Multiple Patienten Receiver by Nihon Kohden Corp.
  422. Safety Notice for diagnostic ultrasound systems Aplio XG and MX and Xario XG, Toshiba
  423. Field Safety Notice for Artis zee systems, Siemens Healthcare
  424. Safety Notice for Leonardo Workstation, Siemens
  425. Lot recall for von Willebrand Reagent, Siemens
  426. Recall for Chocolate agar + PolyViteX VCAT 3, Biomerieux
  427. Lot Recall for Dycal, Calcium Hydroxide Liner, DENTSPLY DeTrey
  428. Safety Notice concerning ophthalmic laser applications in eyes containing KAMRA™-inlays…
  429. Risks with the infusion pump Infusomat Space from B.Braun
  430. Recall of Access Thyroglobulin Antibody II A32898 (Lot-No. 012741, 014751, 016551 and…
  431. Recall of the DYONICS 25 Patient Tube Set, Smith & Nephew
  432. Recall of a lot number of silicone tubing sets for use in a heart-lung machine from Maquet…
  433. Software update on PEGASUS infusion pumps
  434. Corrective action for Dimension Vista Enzyme 1 Calibrator, Siemens
  435. Lot recall for Super Arrow-Flex Percutaneous Sheath Introducer Set, Arrow International…
  436. Urgent Field Safety Notice for Reverse Loaded Wire Guides by Cook Incorporated
  437. Urgent Field Safety Notice for Cefiderocol on Sensititre plates by Thermo Fisher…
  438. Urgent Field Safety Notice for da Vinci X and Xi Reusable Instruments with Jaws by…
  439. Recall of the New 2-part GN Carbon Targeting Device from Plus Orthopedics
  440. Information for Logical®, Novatrans® and Transtar®, Smiths Medical
  441. Recall of Swan-Ganz-CCO-Catheters
  442. Urgent Field Safety Notice for Domiflex, elektr. Pflegebett by Hermann Bock GmbH
  443. Urgent Field Safety Notice for Grasping Retractor, Tenaculum Forceps by Intuitive…
  444. Failure of electric drive functions at the operating table JUPITER from Trumpf
  445. Urgent Field Safety Notice for MonojectT Syringe with Hypodermic Safety Needle, Hypodermic…
  446. Urgent Field Safety Notice for Guidestar Steerable Guiding Sheath by Oscor Inc.
  447. Recall of the ABSOLOK Extra Ligating Clip Cartridge
  448. Corrective action for the MultiDiagnost Eleva II/TV systems, Philips Healthcare
  449. Recall for the device Xelma®, Mönlycke Health Care
  450. Urgent field safety notice for Brio rechargeable IPG (Code 65-6788), St. Jude Medical
  451. Information for Innova, GE Healthcare
  452. Urgent Safety Notice for Bladder Scanner PadScan HD5, Caresono Technology Co., Ltd.
  453. Safety Notice for iPlan RT Dose and VARIS version 6.2 or below, BrainLAB
  454. Recall for Medtronic Adjustable Pulmonary Vein Ablation Catheter, Medtronic
  455. Corrective action for Siemens Capillary Caps, Siemens Healthcare Diagnostics Inc.
  456. Lot recall for ARCHITECT STAT High Sensitive Troponin-I Reagent Kit, Abbott Ireland…
  457. Recall for T2 OFx Tibia Nails, Stryker
  458. Urgent Field Safety Notice for aura6000® Remote Control and Charger; 500.0100 / NA by…
  459. Medtronic recalls LIFEPAK 500
  460. Recall of the adsorption column Cellsorba FX Asahi Kasei Medical
  461. Recall of implantable POLYSITE ports
  462. Recall of Roche for Sta-Liatest D-Di
  463. Information for Natural Knee II System, Zimmer
  464. Field safety notice for VariSeed users, Varian Medical systems
  465. Urgent Safety Notice for the DuraDiagnost X-Ray system, Philips Healthcare
  466. Urgent Field Safety Notice for Artikon.genu-bi-lock Systemkniegelenksatz mit Sperre…
  467. Sysmex CS-5100 System
  468. Corrective action for the Philips Allura FC, Philips Healthcare
  469. Urgent Field Safety Notice for aura6000® Remote Control and Charger; 500.0100 / NA by…
  470. Safety Notice for washer disinfector ETD GA, Olympus Deutschland GmbH
  471. Information for Lifepak defibrillators, Medtronic
  472. Information for MEDUMAT Transport, Weinmann
  473. Recall of double foot switch KF21, Ziehm
  474. Safety Notice for the product RaySearch RayStation 2.5, 3.0, 3.5 and 4.0, RaySearch…
  475. Boston Scientific recalls the Constellation Advanced Mapping catheters
  476. Dräger updates the corrective action of the AIR dual plug connectors
  477. Information for InstaTrak 3500 Plus, GE Healthcare
  478. Urgent Field Safety Notice for Allura Xper and Integris Allura Systems by Philips Medical…
  479. Information about Acuity ConeBeam Computed Tomography, Varian medical systems
  480. Safety Notice for DYONICS POWER II Control Unit, Smith &Nephew
  481. Corrective action for Renaissance System Brain Application Skull Screws made of Titanium…
  482. Field safety notice concerning Ropox Hudson Shower Bed, Ropox A/S
  483. Recall for Rheumatoid Factor (RF) Reagent, Beckman Coulter
  484. Recall for Access Immunoassay System AccuTnI Reagent Kit, Beckman Coulter
  485. Crrective action of the AD5/AD6 patient tables from Philips
  486. Urgent Field Safety Notice for BD Vacutainer Plus Serum Separator tube (SST II) by Becton…
  487. Urgent field safety notice for CyberKnife System, Accuray
  488. Urgent field safety notice for corpuls 08/16 BI / 08/16 S BI / 08/16 E BI, GS…
  489. Remedy possibilities in case of leakages of the RetrO and XpressO dialysis catheters from…
  490. Recall of the vascular prosthesis InterGard Knitted Heparin from InterVascular
  491. Corrective Action for FC 500 with CXP 2.2 Acquisition Software
  492. Recall of Niti-S Colorectal-Stents from Taewoong Medical
  493. Corrective action for the IntellaTip MiFi™ Open-Irrigated Ablation Catheter, Boston…
  494. Recall for Internal Defibrillation Paddles and Handles without discharge control for use…
  495. Safety Notice for COULTER PrepPlus and COULTER PrepPlus 2, Beckmann Coulter
  496. Urgent Field Safety Notice for Percuvance 29cm Shaft Percuvance 36cm Shaft by Teleflex…
  497. Problems with the AXIOM Artis X-Ray systems from Siemens
  498. Safety Notice for the BALTACCI Infusion Catheters, Balt Extrusion
  499. Information of OneTouch® UltraEasy® System Kits from Lifescan
  500. Safety Notice for Desktop Pro™ R7.01, Elekta

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