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International device safety notices

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

  1. Safety Information for Inflow/Outflow Cannula, Stryker Endoscopy
  2. Zimmer GmbH informs about a recall of the instruments Revitan Straight and Curved…
  3. Recall for Clearview Troponin I, Unipath
  4. Safety Notice for NovaFlex Delivery System, Edwards Lifesciences Services
  5. Urgent field safety notice for Efficia CMS200 central monitor system, Philips Healthcare
  6. Information for the stretcher TRIO Mobile Surgery Platform from Stryker
  7. Information for Elecsys® Folate III, Roche
  8. Recall regarding the device LPCCC2: Low Profile Abutment, Non-Hexed Castable Cylinder…
  9. Recall of several lots of Osseofix Implants, Alphatec Spine
  10. Field Safety Notice concerning corrective actions on Explorer and Discovery X-ray Bone…
  11. Recall of one lot of the Optivac Knee Nozzle, Biomet France SARL
  12. Safety Notice for TruSat Pulse Oximeter with external power supply, GE Healthcare Finland…
  13. Recall for Arteriofix V Arterial catheter kits, B. Braun Melsungen
  14. Expanded Recall concerning laryngoscope handles manufactured by M. A. Arain & Brothers…
  15. Follow-up Field Safety Notice for S/5 iCentral and iCentral Client, GE Healthcare
  16. Safety Notice for Minstrel lift devices, ArjoHuntleigh
  17. Urgent Field Safety Notice for iGFBP-1 Rapid Test Cassette (Vaginal Secretion) by Hangzhou…
  18. GE Healthcare has issued an information about field corrective actions
  19. Lot Recall for Genesis II Tibial Drill Guide, Smith & Nephew
  20. Recall of several Weck® Vista™ laparoscopic Ports, Teleflex
  21. Recall of High Flow Blood/Fluid Disposable Sets from Arizant
  22. Corrective action of Abbott for FreeStyle™, Freestyle Mini™, Precision Xtra™ and Precision…
  23. Safety Notice for Birthing Bed Mattresses, Huntleigh Healthcare
  24. Urgent Field Safety Notice for Splash Pool Lift, S. R. Smith
  25. Urgent field safety notice for modular femoral heads (CoCr) / Protasul S30 femoral heads /…
  26. Urgent Field Safety Notice for NEOselect, NEOonsite - Data Analysis & NEOdb by NEO New…
  27. Urgent Field Safety Notice for DASH Omnipod Insulin Management System by Insulet…
  28. Recall of Radical Handheld Pulse Oximeters from Masimo
  29. Urgent Field Safety Notice for Edwards Commander Delivery System by Edwards Lifesciences…
  30. Corrective action of AxSYM Troponin I ADV, AxSYM CA125, AxSYM Folate and AxSYM Myoglobin…
  31. Recall Epic™, Boston Sientific
  32. Safety Notice for certain versions of the Philips iSite PACS product containing iSite AVT…
  33. Safety Notice concerning a mispositioning of source, Eckert & Ziegler BEBIG GmbH
  34. Urgent Field Safety Notice for Stealth, Surgical Spring Clip by Applied Medical Resources
  35. Information for the use of the Ablatherm Integrating Imaging system, EDAP
  36. Urgent Field Safety Notice for AQUIOS CL Flow Cytometer System by Beckman Coulter Ireland…
  37. Corrective action of Biosystems for 5-hydroxyindoleacetic acid
  38. Recall for 5,5mm TroQ Trocar Spikes, Olympus Winter & Ibe GmbH
  39. Urgent Field Safety Notice for HITACHI by Hitachi, Ltd.
  40. Urgent Field Safety Notice for Video Processor, Video Colonoscopes, Video Upper GI Scopes…
  41. Trocar, abdominal / Bladeless trocar, Universal trocar, Dilating tip trocar, Blunt tip…
  42. Corrective action of the ERBE Helix Hydro-Jet
  43. Safety Notice for semi-automated external defibrillators cardioLife AED, Nihon Kohden
  44. Information concerning the mobile OR-table 1131.12X0, BETASTAR from Maquet
  45. Recall for Prelude Short Sheath Introducer, Merit Medical
  46. Lot recall of Check-Flo hemostasis assembly / Flexor radial access sets / TriForce…
  47. Recall for ESTEEM BLUE with NEU-THERA Surgeon Gloves, Cardinal Health
  48. Urgent Safety Notice for Mika™ Speedblock,Encore Medical LLC
  49. Important Information regarding the safe use of Medtronic insulin pumps, Medtronic
  50. Recall of the Aiming Arms 125° and 130° for Static Distal Locking, DePuy Synthes
  51. Recall of controller units of implantable HeartWare VAS, HeartWare Inc.
  52. Urgent Field Safety Notice for Optipac Vacuum mixing systemt by Biomet France SARL
  53. Safety Notice for AXIOM Luminos TF, Siemens
  54. Corrective action for the RAYSTATION 3.5, 4.0, 4.5 and 4.7, RaySearch Laboratories AB
  55. Urgent Field Safety Notice for Extension Device 1180.19A0, MAQUET GmbH
  56. Medical Device
  57. Philips has issued an information that due to a software error of the HD11 Diagnostic…
  58. Corrective action for the LCS COMPLETE RPS Knee System, DePuy Orthopaedics, Inc.
  59. Urgent field safety notice for V60 respiratory ventilator with version 2.20 software…
  60. Mevatron / Primus, Primus Plus / Oncor, Linear Accelerator
  61. Corrective action for the ADVIA Centaur® XPT system, Siemens Healthcare Diagnostics
  62. Safety Notice for the Magnus carbon-fibre table tops, Maquet
  63. Urgent Field Safety Notice for B·R·A·H·M·S uE3 KRYPTOR by BRAHMS GmbH, part of…
  64. Recall of the Transseptal Sheath, 16.5F with Dilator from ProRhythm
  65. Urgent Field Safety Notice for IMPIX MANTA preloaded on holder by Medicrea International
  66. Safety Notice about HMRS Anchorage Stems, Stryker
  67. Field Safety Notice of the Giraffe Omnibed incubator from GE Healthcare
  68. Sets for catheterization of central veins according to Seldinger set Certofix Mono V420
  69. Software-upgrade of the Lifepak 20 defibrillator with software version 48 or 52 from…
  70. Urgent Field Safety Notice for Q-Flow by Merivaara Corporation
  71. Lot recall of sterile disposable feeding bottles / sterile disposable breast milk…
  72. Urgent Field Safety Notice for Dimension Vista Calcium Flex reagent cartridge by Siemens…
  73. Urgent Field Safety Notice for DERIVO 2 Embolisation Device by Acandis GmbH & Co. KG
  74. Recall of the iView DAB Detection Kits from Ventana Medical Systems
  75. Corrective action for CELL-DYN 3000CS und CELL-DYN 3000SL analyzers, Abbott
  76. Urgent Field Safety Notice for DERIVO 2heal Embolisation Device by Acandis GmbH & Co. KG
  77. Recall of the S4 Adjustable Cross Connector 60-75 MM SW699T from Aesculap
  78. Recall of the suture Sulene from Serag-Wiessner
  79. Extended recall of Ureter catheters, Teleflex Medical
  80. Recall of the Chiaglia Blue Rhino Percutaneous Tracheostomy Introducer Set from Wiliam…
  81. Safety Notice for ResMed Power Station, ResMed
  82. Recall of the Rexpol-Einsätze Standard from Plus Orthopedics
  83. Safety Notice for Scorpio Punch Thru Tibial Baseplates, Stryker
  84. EchoSpeed MRI System
  85. Safety Notice for the Portal Review application software of the syngo RT Therapist version…
  86. Recall for RAPID Point 40 X Software, Siemens
  87. Urgent Field Safety Notice for Insulin Syringe Reservoirs Model 1850 and 3070, Applied…
  88. Procare B40
  89. Bio-Rad IH-QC1 - nõrgem või negatiivne vastus D positiivsetele rakkudele kindlat…
  90. cobas 8000
  91. ATTUNE FB TIB BASE SZ
  92. Safety Notice for Symbia T and Symbia T2 camera systems, Siemens
  93. Urgent Field Safety Notice for BCID and BCID2 Panel by BioFire Diagnostics, LLC
  94. Recall of one lot-number Biolox V40 Delta Ceramic Head by Stryker Orthopedics
  95. Recall Lactosorb Heat Contouring Pen, Biomet
  96. Corrective action for Siemens N Latex CDT Kit, Siemens Healthcare Diagnostics
  97. Urgent Field Safety Notice for Cordis Vista Brite and ADROIT Guiding Catheter by Cordis…
  98. Recall of Ablation Catheters HIFU-ST01-25 and HIFU-ST01-30 from ProRhythm
  99. Safety Notice for 4DITC, Varian Medical Systems
  100. Lot recall for QuantiFERON-TB (QFT) Gold TB-Antigen blood collection tubes, QIAGEN GmbH
  101. Fractures of the backrest tubes of the folding wheelchair Action³ from Invacare
  102. Anomaly identified with CT Localization module of FastPlan Treatment planning system…
  103. Software Update for all VISULAS 532s VITE systems, Carl Zeiss Meditec
  104. Further Safety Information regarding Dade® Actin® Activated Cephaloplastin Reagent…
  105. Lot recall of various spine instruments, DePuy Synthes / Synthes GmbH
  106. Products for X-ray endovascular surgery: balloon dilatation catheters for percutaneous…
  107. Urgent field safety notice for Danis Procedure Pack / Basic, ELLA-CS s.r.o.
  108. Urgent Safety Notice for Cadisc-L Lumbar Disc Replacement Device, RANIER
  109. Urgent Field Safety Notice for HeartStart MRx by Philips Healthcare
  110. Correct use of the secondary locking mechanism of BrainLAB-Couchmount
  111. Information concerning the software iPlan Cranial 2.6, iPlan ENT 2.6, iPlan Stereotaxy 2.6…
  112. Recall of different Lots of iUni® Knee Repair Systems
  113. Corrective action for the Access Total T4 Reagent Kit, Beckman Coulter
  114. Information concerning the MiniMed Paradigm® Insulin Infusion Pump from Medtronic
  115. Urgent Field Safety Notice for Liftkar PT by Sano Transportgeräte GmbH
  116. No-output condition of Ela Medical pacemakers Symphony und Rhapsody
  117. Boston Scientific recalls Hemashield Vantage™ Vascular Grafts
  118. Information for the LAP Dorado Laser System
  119. Recall of the Vitros Immundiagnostic Products Troponin I Reagent Packs from Ortho
  120. Urgent Safety Notice for Dual Chamber Models of Pacemakers, Medtronic
  121. Risk in the use of 850 Humidification Systems from Fisher & Paykel with non original…
  122. Recall of LactoSorb Pectus Stabilizer, Biomet
  123. Safety Notice for MAGNETOM ESSENZA 1,5 T, Siemens Healthcare
  124. Software failure of Zeus software version 3.1 from Dräger
  125. Urgent Safety Notice for Terumo® Weighted Flexible Sucker, Terumo Europe NV
  126. Urgent field safety notice for multiFiltratePRO devices, Fresenius Medical Care AG & Co…
  127. Urgent Field Safety Notice for Getinge 86- and 88-series by Getinge Disinfection AB
  128. Urgent Field Safety Notice for Cell-Dyn Ruby Analyzer by Abbott Laboratories
  129. Urgent Field Safety Notice for SAPPHIRE administration Sets by ICU Medical
  130. Recall of one lot of the product Biomedics 1 day toric contact lenses, CooperVision
  131. Corrective action for the HCYS Homocysteine enzymatic assay, Roche
  132. Urgent Field Safety Notice for ExacTrac by Brainlab AG
  133. Urgent Field Safety Notice for Optime, GXPS-500, Express, Scan eXam by PaloDEx Group Oy
  134. aap Implantate recalls Biorigider Nagel Femur
  135. Information for the CADD-Legacy Duodopa Pump, Model 1400 from Smiths Medical
  136. Recall of Trail neck XXL with 40 mm femur axis distance, Waldemar Link
  137. Urgent Field Safety Notice for URF-V2/URF-V2R flex. videoureteroscope by Olympus Medical…
  138. WIZARD2 Gamma Counter
  139. Recall/Exchange for all oxygen connection tubes, EMS
  140. Incorrect couch position that are displayed on the monitor of Brilliance CT scanners from…
  141. Recall of certain Fred Easy Defibrillators from Schiller
  142. Corrective action for Dimension ALDL Calibrator, Siemens Healthcare
  143. Recall for IDS Ostase BAP ELISA, Immunodiagnostic Systems
  144. Corrective action for the TomoTherapy® Treatment Delivery Systems, Accuray Inc.
  145. Information about Spectra Optia Apheresis System, Gambro
  146. Safety Notice for the Kimal Procedure Packs containing Needle 18G x 7cm Sing Wall Cordis…
  147. Recall of ProcedurePak trays containing Syringe 100 ml 3parts Cath. tip Conc. W/LS Adapter…
  148. Corrective action and recall for the BCS Stirring Rack Unit of Dade Behring
  149. Recall for Dimension CTNI Flex reagent cartridge, Siemens Healthcare
  150. Recall for the CODMAN® 3000 Refill Kit - Huber Needles, Codman Neuro
  151. Corrective Action regarding DDU-100 series AEDs, Defibtech
  152. Recall of UniCel DxC600/600i/800 Synchron Clinical Systems Operating-Software from Beckman…
  153. Field Safety Notice about a software update of specific versions of CARESCAPE CIC Pro…
  154. Recall of elastomeric AccuFlo infusion pumps, Medpro International Ltd
  155. Urgent field safety notice for defibrillator battery FRED easy, Schiller Medical SAS
  156. Urgent Safety Notice for the XO 4 dental unit, XO Care A/S
  157. Urgent Field Safety Notice for MicroScan LabPro Information Manager System by Beckman…
  158. Recall DHS Blade, Synthes
  159. Recall for CrystalClear Tracheostomy Tubes Cuffed, the CrystalClear PTD Sets and the…
  160. Expansion of the recall of Bard Composix Kugel Patches
  161. Recall for Rayner Sulcoflex Aspheric, Rayner Intraocular Lenses Ltd.
  162. Information concerning the Polymobil III and Polymobil Plus systems from Siemens
  163. Recall ACD-A bags, Fresenius Kabi AG
  164. Urgent Field Safety Notice for Ysio by Siemens Healthcare GmbH, X-Ray Products (XP)
  165. Lot recall of MobiCath Bi-Directional Guiding Sheath, Greatbatch Medical / MPS Medical…
  166. Corrective action for CRP Latex of Olympus
  167. Recall of the 3.5 mm 90-S SERFAS Energy Suction Probe from Stryker Europe
  168. Safety Notice for Martel Printer - Rechargeable Battery Pack, Abbott
  169. Urgent Field Safety Notice for DiaSpect Hemoglobin T-LOW by DiaSpect Medical GmbH
  170. Recall for Urea CT FS, DiaSys
  171. Lot Recall for Single-Spiral Soft Platinum J-Coil Hydrophilic Lock, William Cook Europe
  172. Recall of the Stonetome™ Single-Use Stone Removal Device from Boston Scientific
  173. Recall of the Traumacem Needle Kit, Möller Medical GmbH and Synthes GmbH
  174. Urgent Field Safety Notice for Sysmex XN 550 by Sysmex Corporation
  175. Recall of HI REXPOL Einsatz Dysplasie by Plus Orthopedics
  176. Safety Notice for FreeStyle Navigator Continuous Glucose Monitoring System and Navigator…
  177. Recall of PFO Occluders from AGA Medical
  178. Recall of Surgical Instrumentkit for THA with „Unique“ customized femoral stem from…
  179. Lot Recall for NexGen® Complete Knee Solution Cruciate Retaining Articular Surface, Zimmer…
  180. Safety Notice concerning the product “Heated Expiratory Limb 150cm Neonatal”, Medisize
  181. Recall of several batches of BD Difco Salmonella O and Shigella Antiserum Groups from…
  182. Corrective action of Ortho Clinical Diagnostics for Vitros Systems
  183. Corrective action and recall of FreeStyle Mini, FreeStyle Freedom and Freestyle from…
  184. Recall for TransFx Drill Bit, Zimmer
  185. Urgent Safety Notice for MX 4000, MX 4000 Dual and MX 6000 Dual, Philips
  186. Recall for CellEx Photopheresis Procedural Kit, Therakos, Inc.
  187. Safety Notice for Getinge Washer Disinfector 8666 and 8668, Getinge Group
  188. Information for BrainSCAN and iPlan RT-treatment planning software, Brainlab
  189. UMONIUM38 Medical Spray
  190. Recall of the STA Liatest Free Protein S from Roche
  191. Recall Phaco Needles, Bausch & Lomb
  192. Corrective action/Recall for Dimension Clinical Chemistry System, Siemens
  193. Information for safe operation of the Stereotactic Circular Collimator, Elekta
  194. Retrofitting of Walker Avant, Avant LW and Salsa, Etac
  195. Recall of the CODMAN® CERTAS™ Therapy Management System (TMS) 1st generation, Codman…
  196. Urgent Field Safety Notice for Mon-a-ThermT Foley catheters with temperature sensors by…
  197. Recall for Mantis Rod Inserter Shaft, Stryker
  198. Recall for the Airtraq optical laryngoscope, Prodol Meditec
  199. Urgent Field Safety Notice for ChromoView Monitor carrier arm by Berchtold Holding GmbH
  200. Urgent Field Safety Notice for Pulsar-35 by BIOTRONIK AG
  201. Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG
  202. Safety Notice for Inion CPS and Inion CPS Baby, Inion
  203. Recall for Kalix II foot implant, Newdeal SAS
  204. Corrective measures of the Gambro Prismaflex™ Continuous Renal Replacement System from…
  205. Safety Notice for HeartStart XL M4735A Defibrillator/Monitor, Philips
  206. Safety Notice for syngo Dynamics, Siemens Healthcare
  207. Lot recall of LaserEdge Knives, Valeant Pharmaceuticals International Inc. / Bausch & Lomb
  208. Advisory Notice of LIFEPAK 20 from Medtronic
  209. Lot recall for RESTORIS MCK Baseplate, Stryker Orthopaedics
  210. Urgent Field Safety Notice for BOND Ready-to-Use Primary Antibody Bcl-6 (LN22) by Leica…
  211. Corrective action for Stratus CS Acute Care Troponin I TestPak, Siemens
  212. Urgent field safety notice for Alaris PK Plus Syringe Pump, CareFusion
  213. Urgent Field Safety Notice for Tissu-Trans by Shippert Medical Technologies
  214. Corrective action of BioMerieux for Vidas Troponin I
  215. Lot recall for Inflation Devices, Spiggle & Theis Medizintechnik GmbH
  216. Urgent Field Safety Notice for Uterine Aspiration Tube by GCMedica Enterprise Ltd.(Wuxi)
  217. Safety Notice for HeartStart MRx/MRxE, Philips
  218. Urgent Field Safety Notice for CMI@ - Collagen Meniscus lmplant by Ivy Sports Medicine
  219. Information about HeartState F2+ defibrillator from Philips Medical Systems
  220. Juno DRF
  221. Corrective action of the Coulter LH 780 Hematology Analyzers from Beckman Coulter
  222. Corrective action of the Coulter LH 750 Hematology Analyzers from Beckman Coulter
  223. Corrective action for Cobas Integra systems, Roche
  224. Safety Notice for Welch Allyn CP 200, Welch Allyn Ltd.
  225. Urgent Field Safety Notice for MyLab Twice/Esaote/Esaote by Esaote S.p.A. (Firenze)
  226. Corrective action for Roche/Hitachi Systems, Roche
  227. Corrective action of the Coulter LH 500 Hematology Analyzers from Beckman Coulter
  228. Argon recalls the 10cc/12cc Sterile or Non-Sterile Control Syringes and Sterile or…
  229. Corrective action of the Coulter GENOS Hematology Analyzers from Beckman Coulter
  230. Recall of the triglyceride reagent OSR6133 from Olympus
  231. Lot recall of LASEREDGE 2.0 mm x 2.2 mm Trapezoid Angled 6 / Box SKU#E7601, Valeant…
  232. Urgent field safety notice for Helical infusion catheter and steerable Morph universal…
  233. Corrective action and recall of BioMerieux for the BacT/Alert Classic 120 System and the…
  234. Recall of the Chemosite System - Peel Away Sheath Introducer from Tyco Healthcare
  235. Urgent Field Safety Notice for UROSKOP OMNIA and UROSKOP OMNIA MAX by Siemens Healthcare…
  236. Corrective action and recall of the Olympus Clinical Chemistry Analyser AU5400 with the…
  237. Recall for the NexGen® Complete Knee Solution Stemmed & Rotating Hinge Knee Tibial Broach…
  238. Corrective action and recall of BioMerieux for BacT/Alert PF
  239. Recall for "stainless steel arch wire natural upper", Highland Metals Inc.
  240. Safety Notice for Pegasus and Megasus Stretcher Trolley, Ferno
  241. Mediace TPLA Calibrator Set
  242. Urgent Recall for Cuffed Shiley™ Tracheostomy Products, Covidien
  243. Urgent Field Safety Notice for Navigation Marker Spheres by Neuromedex GmbH
  244. Information about UV-Flash-Compact devices from Baxter
  245. Corrective action concerning PENTAX Ultrasound UPPER GI Video Scopes, HOYA CORPORATION…
  246. Warning for OMNEX Surgical Sealant from the company Ethicon
  247. Recall of power supplies for FlowScreen flowmeters from Viasys
  248. Urgent Field Safety Notice for ACUSON Juniper Diagnostic Ultrasound System by Siemens…
  249. Information for the use of Hem-o-lok large clip from Teleflex
  250. Safety Notice: Lack of sterility of paediatric urine collectors for boys and girls in…
  251. Recall for Therakos Uvar XTS-Photopheresis System, Therakos Inc.
  252. Safety Notice for MultiPlan®Treatment Planning Software Versions, Accuray
  253. Safety Notice concerning a corrective action of the X-Series, Propaq MD und Propaq M…
  254. Recall for PFC Sigma Femoral System, DePuy
  255. Corrective action of Abbott for Architect Folate Reagent
  256. Urgent field safety information for Leg Holder HEAVY T pads, TRUMPF Medizin Systeme GmbH +…
  257. Recall of affected lots of the coronay stent “Cypher Select ™+“, Cordis
  258. Urgent Field Safety Notice for Lifepak 20/20e by Physio-Control, Inc.
  259. Recall and corrective action of Dade Behring for Coagulation Factor VIII Deficient Plasma
  260. Corrective action of the Surgical Lighting and Media Systems Harmony LA, LC 500 and LA…
  261. Corrective action and recall for Cytomics Flow Cytometry Systems, Beckman Coulter
  262. Corrective action for ADVIA Centaur CP AFP assay, Siemens
  263. Corrective action for electromyography system Schwarzer topas EMG, Natus Europe GmbH
  264. Urgent Field Safety Notice for DHEA ELISA by IBL International GmbH
  265. DePuy Synthes: Recall of the Sleeve for ASLS, Diameter 5.0mm, resorbable
  266. Field Safety Notice of The ProcedurePak “Oberbauch Set 1715189-05”
  267. Recall for OBIS Salmonella, Oxoid
  268. Urgent Field Safety Notice for Triathlon Knee System 5mm & 10mm Tibial Augment by Stryker…
  269. Recall DryMax Dressing, Absorbest
  270. Urgent field safety notice for VITROS 5600 Integrated Systems, Ortho Clinical Diagnostics
  271. Safety Notice for Sola 300 examination lights, Dräger Medical
  272. Urgent Field Safety Notice for ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM by Aesculap AG
  273. Urgent Field Safety Notice for TRACOE experc Set twist, twist plus, vario by TRACOE…
  274. Recall of METRxTMMED Procedure Kits from Medtronic
  275. Safety Notice concerning secondary Dose Calculation Error under the MLC leaves (Monaco)…
  276. Recall of several Polyethylene Implants, Zimmer
  277. Urgent Field Safety Notice for Tensive Conductive Adhesive Gel by Parker Laboratories…
  278. Anomaly in CadPlan version 6.4.7 from Varian
  279. Recall of different sterile invasive single use devices from ConMed Linvatec
  280. Urgent Field Safety Notice for ExcelsiusGPS by Globus Medical, Inc.
  281. Software update of the On-Board Imager from Varian
  282. Replacement of PEGA® CHARGER power supply devices from Pegasus
  283. Lot recall of TIPSS-200 Transjugular Intrahepatic Portosystemic Shunt Procedure Pack…
  284. Urgent Field Safety Notice for IntelliBridge EC10 Module by Philips Medizin Systeme…
  285. Lot recall of Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits, Teleflex…
  286. Educational Brief regarding pain pump patient management with its programmable infusion…
  287. Information about OEC products, GE Healthcare
  288. Corrective action for cobas c 502 module, Roche
  289. Information about DST-XL Gamma Camera, GE Healthcare
  290. Recall for Ciaglia Blue Dolphin Balloon Percutaneous Tracheostomy Introducer Set (with…
  291. Corrective action of BioMerieux for Vidas LSX reagent
  292. Recall of the Kompaktor from Richard Wolf
  293. Information for Architect i1000SR Modul, Abbott
  294. Urgent field safety notice for mikrozid sensitive wipes premium, Schülke & Mayr GmbH
  295. Urgent Field Safety Notice for Reveal LINQ Insertable Cardiac Monitor (ICM) Model LNQ11…
  296. Expanded Recall for ARCHITECT Reaction Vessels, Abbott
  297. Corrective action and Recall for IEEE detectors installed with Empower 2 FR5, Empower 3 or…
  298. Corrective action for the product PRO-Trac™ II Tacrolimus ELISA Kit, DiaSorin S.p.A.
  299. Urgent field safety notice for Glucose 201 RT Microcuvettes, HemoCue AB
  300. Corrective action of Lifepak 12 and Lifepak 20, Medtronic
  301. Safety Notice for Refa8 and Refa-ext physiological amplifiers, TMS International B.V.
  302. Software update of the MRI-Patient Monitoring Systems Precess 3160 from Invivo
  303. Information about Dimension Clinical Chemistry System, Siemens
  304. Safety Notice for Brainlab Navigation Software Knee, BRAINLAB AG
  305. Medtronic Powered Surgical Solutions recalls the Midas Rex Legend Pneumatic PM110 Gold…
  306. Corrective action and recall of BioMerieux for BacT/Alert MP & MB
  307. Recall for the Ratcheting Torque Limiting Handle, Orthofix Inc.
  308. Recall of C-Peptide Kits from Laison
  309. Zimmer TMT recalls all TM-400 Broach Handles
  310. Safety Notice for AXIOM Aristos FX and FX Plus, Siemens Healthcare
  311. Field Safety Notice concerning usage of NO-therapy Device in combination with a Patient…
  312. Urgent Field Safety Notice for HEINE F.O. SP Laryngoskop Griff by HEINE Optotechnik GmbH &…
  313. Safety Notice for Signa 3T Magnetic Resonance Systems, GE Healthcare
  314. Faulty displayed replacement date in implantable drug infusion pumps SynchroMed II model…
  315. Lot Recall of the single use cutting burs, Anspach
  316. Urgent field safety notice for Aiming Arm for DFN / combined / for PAD, DePuy Synthes /…
  317. Urgent Field Safety Notice for Imager II Angiographic Catheter by Boston Scientific…
  318. Replacement of Wast Bottles for ABL700 and ABL800 Analysers, Radiometer
  319. Recall for VITROS Immunodiagnostic Products CA 125 II Reagent Packs, Ortho-Clinical…
  320. Lot recall of Hydrophilic Acrylic Single Use lntraocular Lens system packs, Rayner…
  321. Urgent Field Safety Notice for MicroScan LabPro Information Manager System by Beckman…
  322. Recall Dermacarriers II Skin Graft Carriers and Dermacarriers Skin Graft Carriers, Zimmer
  323. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
  324. Recall of the Morcellator Cutters 12 mm for Use with RotoCut G1 System from Karl Storz…
  325. Urgent field safety notice for RFX/SFX / Legacy / Precision 500D, GE Healthcare
  326. Corrective Action for HeartStart FR3, Philips
  327. Safety Notice for the product IMTEC-CIC IgG ELISA, HUMAN Gesellschaft für Biochemica und…
  328. Corrective action for the VITROS® 5,1 FS Chemistry Systems, Ortho-Clinical Diagnostics…
  329. Urgent Field Safety Notice for Mentype MycoDermQS Lateral Flow by Biotype Diagnostic GmbH
  330. Corrective Action for small soft carry cases used with AED, Philips
  331. Safety Notice for EUB-5500, EUB-6500HV, EUB-7500, EUB-8500 and HI Vision 900, Hitachi
  332. Recall of specific lots of Renma PTA Dilatation Catheters, ClearStream Technologies Ltd.
  333. Safety Notice for the surgical suction pumps NEW HOSPIVAC 400, CA-MI Srl
  334. Corrective action of BioMerieux for Vidas LSX reagent
  335. Safety Notice for E Series BLS Defibrillator, Zoll
  336. Urgent field safety notice for kits Simplexa HSV 1 & 2 Direct, Simplexa Flu A/B & RSV…
  337. Recall for Waste Reservoir Assembly (Waste Chamber), Abbott
  338. Safety Notice concerning a manufacturing anomaly for Type 3 hard wedges, Varian medical…
  339. Safety Notice for the HomeChoice/HomeChoice PRO automated peritoneal dialysis systems…
  340. Safety Notice for Gemini TF 16 and 64, Gemini GXL 16 and Extended Brilliance Workspace…
  341. Recall of radial head prosthesis MoPyC, Tornier
  342. Exchange the castors of Pentax-Videocarts K125, K125E and K113, Knürr AG
  343. Information for CellTracks® AutoPrep® System / Waste bottle, Veridex
  344. Recall of the NextStent™ Carotid Stents and Monorail™ Delivery Systems from Boston…
  345. Information about CT scanners, Philips
  346. Urgent Safety Notice for the Innova Cardiovascular X-ray imaging systems equipped with CE…
  347. Urgent Field Safety Notice for POWER LINE 4000 LEG PRESS 4xxx MED und SQUAT PRESS 4xxx…
  348. Guidant recalls the HEARTSTRING II Aortic Cutters
  349. Lot Recall for Back-up Meier Steerable Guidewires, Boston Scientific
  350. Recall of S.M.A.R.T. Flex Vascular Stent System, Cordis Corporation
  351. Urgent Field Safety Notice for CAMILINO by AAT Alber Antriebstechnik GmbH
  352. Recall of ImmunoCard Toxins A & B, Meridian Bioscience
  353. Recall MC-GDHK-1120 dialysis catheter kits, Gambro
  354. Recall for Drain Feed PTCD Catheter, Peter Pflugbeil GmbH
  355. Urgent field safety notice for VITROS Immunodiagnostic Products Total β-hCG II Reagent…
  356. Corrective action for Volcano R-100 sterile equipment cover (product REF numbers PBKBG and…
  357. Urgent Field Safety Notice for Cutisoft Cotton XR 10cm x 10cm dressing gauze by BSN…
  358. Corrective action for AxSYM analyzers from Abbott
  359. Urgent Field Safety Notice for Bio-Cal Temperature Controller by Medtronic Inc
  360. Information concerning the Raphael ventilator from Hamilton
  361. Tyco recalls Tear Away Introducer Sheaths
  362. Safety Notice for Philips BackOn Track Ortho, Philips Technologie GmbH
  363. Corrective action for the Vitek 2 Piperacillin/Tazobactam Test, Biomerieux
  364. Corrective action and recall of for the Advia 2110 Hematology System from Bayer Healthcare
  365. Safety Notice for Ru-106 Ophthalmic Applicators, IBt Bebig
  366. Recall of Cross-Link Clamps (pre-assembled) for Rods Ø 6.0 mm, DePuy Synthes
  367. Lot recall for MCS+/LDP W/FILTER 994CF-E / CONC PLT & PLS SET W/FILTER 998CF-E / PBSC SET…
  368. Warning of R82 of using the Cheetah Pusch Handle for lifting the chair
  369. Recall of Slidex pneumo kit from Biomerieux
  370. Safety Notice concerning the device for physical exercise Genius Eco, FREI AG
  371. Recall for Antimicrobial Susceptibility Testing Disc SXT 25, Oxoid
  372. Urgent Field Safety Notice for Centricity Universal Viewer by GE HEALTHCARE INTEGRATED IT…
  373. Information from ARGUS for the infusion pumps MCM 500, MCM 504 and ARGUS 200
  374. Recall of the Journey Quick Connect T-Handles from Smith & Nephew
  375. Anomaly identified with Eclipse Treatment Planning System, Varian medical systems
  376. Recall orthosis Tricodur Tutor Pro, BSN medical
  377. Corrective action for Galileo Echo, IMMUCOR
  378. Recall for "Actavis-Mini-Pumpe", Actavis Deutschland GmbH & Co. KG
  379. Recall Topaz XL with Integrated Cable Wands, ArthroCare
  380. Safety Notice concerning Vital Signs Breathing Circuits, GE Healthcare
  381. Urgent Safety Notice for Model 5392 Dual-Chamber External Pulse Generator, Medtronic
  382. Check of the wheels of the Endoscopy Trolleys from Aesculap
  383. Corrective action for Elecsys Vitamin D3 (25-OH), Roche
  384. Corrective action for NucliSens easyMAG Lysis Buffer, Biomerieux
  385. Urgent Field Safety Notice for Oxylog VE300 by Drägerwerk AG & Co. KGaA
  386. Recall Stella Osteotome, BIOMET
  387. Safety Notice concerning LIV 2000, Linde
  388. Recall of the Synergy Porous Femoral component by Smith & Nephew
  389. Urgent Safety Notice for SynPlug® and Optiplug® Cement Restrictors, Integra LifeSciences
  390. Urgent Field Safety Notice for CYTOGUIDE needle guide bushes by Turon MedTech AB
  391. Safety Information for Kappa 600/700/900, Sigma 100/200/300, Cardiotron and MDT 350…
  392. Urgent Safety Notice for the Raucodrape NaCl Bowl Drape, Laboratoires Lohmann & Rauscher…
  393. Recall for Access und Access 2, Beckman Coulter
  394. Enlargement of Corrective Action / Recall for UniCel DxI 600 Systems, UniCel DxI 800…
  395. Recall of one batch number of the product i-Visc 1.4, i-Medical Ophthalmic International…
  396. Safety instruction for the CODMAN High Speed Drill System from Ethicon
  397. Recall for K-Wires, Abbott Spine
  398. Safety Notice for SQRX®PulseGenerator, Cameron Health
  399. Urgent Field Safety Notice for CHA Anesthesia and CHA Critical Care by GE Healthcare
  400. Corrective action for Opti CCA (-TS) sensors from Osmetech
  401. Field Safety Notice for PW810/PW820 Patient Warmer, Fisher & Paykel
  402. Urgent Safety Notice for the Alere Triage® BNP Test for the Beckman Coulter Access Family…
  403. Corrective action and recall from for the software of Olympus systems AU400, AQU640 and…
  404. Urgent Safety Notice for the On-Board Imager® [OBI] device, Varian Medical Systems
  405. Lot recall of Inflation device REF 2080-9030020 LOT 1210127, Spiggle & Theis…
  406. Urgent Field Safety Notice for CAR POLE (component of BQ and BRAIN QUICK series) by…
  407. Recall of components of the Legion knee replacement from Smith & Nephew
  408. Information concerning the FCR Velocity U or FUJIFILM DR Velocity Ufp devices from…
  409. Recall for TPHA 100, Biomerieux
  410. Corrective action for Ca++ membrane units, Radiometer
  411. Recall of aortic cannulas with angled Tip for cardio pulmonary bypass, Terumo Europe…
  412. Lot Recall for the Opalescence Trèswhite Supreme, ULTRADENT PRODUCTS
  413. Prismaflex
  414. Urgent field safety notice for evo and eco c, Schwarzer Cardiotek GmbH
  415. Urgent Field Safety Notice for Cranial Kit - No Drugs by INTEGRA Pain management
  416. Information for Advantage Workstation, GE Healthcare
  417. Recall of pseudophagic intraocular lens A4SW00 acrylic IOL / AddOn / spherical /…
  418. Urgent Field Safety Notice for S-12 Handpiece by W&H Dentalwerk Bürmoos GmbH
  419. Recall of multiple batches of several IV Prep Wipes, Smith & Nephew
  420. Safety Notice / Corrective Action of Waters ACQUITY Sample Organizer
  421. Advisory Notice from aap Implantate for Traumaschulter nach Schauwecker/Müller
  422. Risk with the peritonealdialysis systems HomeChoice and HomeChoice Pro from Baxter
  423. Safety Notice for C500 S-10 R-NET and other R-Net chairs with ESP, Permobil
  424. Batch Recall of a Diamond Ball Standard Cutting Burr, DePuy Synthes
  425. Recall of Lotus valve system, Boston Scientific International S.A.
  426. Recall of Mi1000 PIN drills, MED-EL Elektromedizinische Geräte GmbH
  427. Lot recall of Dimension Sirolimus (SIRO) Flex reagent cartridge, Siemens Healthcare…
  428. Recall of eight lot numbers of the Flexiflo 10 Fr DURA-PEG and one lot of Flexiflo 16 Fr…
  429. Information for Ablatherm HIFU, EDAP TMS France
  430. Corrective action for the Integral Leg Prosthesis, Orthodynamics GmbH
  431. Safety Notice for Definium 5000, GE Healthcare
  432. Urgent Safety Notice for the the transfer aid ReTurn 7400 und 7500, Handicare AB
  433. Recall for RENASYS GO External Power Supply Units, Smith & Nephew Inc.
  434. Field Safety Notice of Triathlon TS Knee System Offset Adapter Trial
  435. Safety Notice for Vital Sign Monitor Model 91220, Spacelabs
  436. Anomaly identified with ARIA Oncology Information Systems, Varian medical systems
  437. Safety Notice for the Terumo® Advanced Perfusion System 1, Terumo
  438. Corrective action for the Omrix Pressure Regulator, Ethicon Biosurgery/Omrix
  439. Urgent Field Safety Notice for EMS-Stretcher by Bucher Leichtbau AG
  440. 7b619492-91f1-2b98-055c-6609c0879927
  441. Sterile disposable products for infusion therapy: peripheral catheters ANGELTOUCH…
  442. DT MedTech, LLC Hintermann Series H3 Total Ankle System - oodatust suurem seadme rikke oht
  443. Corrective Action for ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur CP, Siemens
  444. Recall for Hemoglobin F&A2 Control Set, TOSOH BIOSCIENCE
  445. Corrective Action for i-STAT cTnI cartridges, Abbott
  446. Lot recall for Drill Sleeve 9.0/2.8 length 191 mm for AFN, DePuy Synthes / Synthes GmbH
  447. Urgent Field Safety Notice for NSE PTA Balloon Catheter GDM01 by Goodman Co. Ltd
  448. Safety Notice for Medstream Implantable Drug Pump, Codman
  449. Safety Notice for for DX-D 10G, DX-D 10C, DX-D 20G and DX-D 20C digital detectors, AGFA…
  450. Urgent Field Safety Notice for SPOTCHEM D-00 by Arkray Factory, Inc.
  451. Urgent field notification on generators from Biosense for RF ablation
  452. Safety issue in the set up of the PW810 and PW820 Patient Warmers, Fisher & Paykel
  453. Recall Endopath ETS 35 mm, Johnson & Johnson
  454. Safety Notice: Recall of different sutures, Teleflex
  455. Recall of different sutures, Teleflex
  456. Urgent Field Safety Notice for Bodyguard 121 Twins by Caesarea Medical Electronics Ltd.
  457. Recall of the Defibrillator PIC 50 from the manufacturer WelchAllyn
  458. Corrective action for Nephkit Alpha GST EIA Kit, Biotrin
  459. Recall for BD Insyte TM Autoguard TM IV Catheter, Becton Dickinson
  460. Urgent Field Safety Notice for Alinity s System by Abbott Laboratories, Inc.
  461. Recall unsterile products, Mentor Medical Systems
  462. Information for SERVO-i Ventilator System, Maquet
  463. Urgent field safety notice for G4 Platinum- and G5 Mobile Continuous Glucose Monitoring…
  464. Urgent Field Safety Notice for Aptio Automation by Inpeco SA
  465. Urgent Field Safety Notice for Everest XT MI Inner Dilator and Outer Dilator by Stryker…
  466. Urgent Field Safety Notice for revogene by GenePOC Inc.
  467. Recall of the urinary collecting bags Norta Urobag S from BSN Medical
  468. Recall PointGuard, Bionic
  469. Problem with the AB Portable Circulatory Support System, Abiomed Europe
  470. Recall of the Microcuff Endotracheal Tubes from Unomedical
  471. Urgent Safety Notice for the 550 TxT Treatment Table of the Digital Linear Accelerator…
  472. Urgent Recall for Taurolock™, Tauropharm GmbH
  473. Urgent Field Safety Notice for Capio SLIM Suture -; Capio Open Access Suture - ; Capio…
  474. Safety Notice for the EOS System / sterEOS Workstation, EOS imaging
  475. Information for Stress Table Echo 100 MED, ERGO-FIT
  476. Recall for the Persona Anterior Referencing Locking Boom Femoral Sizer (Instrument)…
  477. Urgent field safety notice for MicroScan LabPro Information Manager System, Beckman…
  478. Recall for DYONICS resection blades, Smith & Nephew
  479. URGENT MEDICAL DEVICE SAFETY ALERT for Comprehensive Nano Humeral Component PPS, BIOMET
  480. Recall for the Irrigation syringe 100/120ml, Asid Bonz GmbH
  481. Recall of CardioFocus Endoscopic Ablation System (EAS) - HeartLight Catheters Lots 7957…
  482. Recalls of several product types of the OPUS SmartStitch® Series from ArthroCare
  483. Recall for Morpheus Smart PICC CT, AngioDynamics, Inc.
  484. Urgent field safety notice for PreciControl Varia, Level 2 - Elecsys® PTH assay on…
  485. Urgent field safety notice for LIFEPAK 15 monitor / defibrillator, PHYSIO-CONTROL Inc.
  486. Recall of Maverick2™ Monorail™ Balloon Catheters from Boston Scientific International S.A.
  487. Safety Notice for Medos Oxygenators
  488. Urgent Safety Notice for Renasys Gauze Dressing Kits, Smith & Nephew
  489. Information for the FloSeal-Kits from Baxter
  490. Recall of CombiSets with BD 10 ml Plastipak catheter tip syringe, PAUL HARTMANN AG
  491. Information for the Varian EXACT couch in combination with BrainLAB ExacTrac Robotics
  492. Recall of several lots of Plus SL Standard Stems, Smith & Nephew
  493. Urgent Field Safety Notice for SARS-CoV-2 Rapid Antigen Test by S. BIOSENSOR, INC.
  494. Recall for Zyoptix® XP Microkeratome Motors, Bausch & Lomb
  495. Urgent Field Safety Notice for SmartAblate RF Generator by Stockert GmbH

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