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International device safety notices

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

  1. Urgent Field Safety Notice for EtCO2 OxyMask by Southmedic, Inc.
  2. Safety Notice for Working Master Mix for LightCycler MRSA Advanced Test, Material No…
  3. Urgent Field Safety Notice for NEFA Unveresterte Fettsäuren by Labor+Technik Eberhard…
  4. Recall for Mini Crosser T-model and E-model scooters, Mini Crosser A/S
  5. Lot Recall of Oxoid Antimicrobial Testing Disc, CT0024B CN10 Gentamicin, Thermo Fisher…
  6. Recall for test-kit PCT direct, BRAHMS
  7. Safety Notice for BD HPMC Solution, Becton Dickinson
  8. Urgent Safety Notice for Terumo® Radifocus Optitorque catheter, Terumo Europe NV
  9. CAPI 3 IMMUNOTYPING
  10. d1f98983-03fd-eff2-e68a-278a8e94b857
  11. ADVIA Centaur / ADVIA Centaur XP - HBsAg II (HBsII)
  12. 58fcd3a7-4eb7-1b12-96ea-8b335525dcc4
  13. 0d5da64e-031c-547a-7b81-a656f148c943
  14. GE Voluson E6 Ultrasound System
  15. Tec 6 Plus Vaporizer
  16. Getinge HLS, HIT Set - võimalik rikutud steriilsus
  17. Fluoroscopic x-ray system BV Libra
  18. TrueBeam STx
  19. Artis zee
  20. Rigid ureterorenoscope
  21. Autocon
  22. Tyvek Rolls
  23. Nutrisafe2
  24. Suction Catheters, Gastro-enteral Tubes, Intermittent Urology Catheters and sterile Urine…
  25. Atrium Ocean, Oasis, and Express Chest Drains
  26. Enzymatic Hemoglobin A1c (A1c_E) reagents
  27. Liftkar PT
  28. m24sp Instrument
  29. DEFIGARD TOUCH7
  30. Emblem S-ICD
  31. Brilliance iCT
  32. b3ce3cad-de52-cca3-f3bc-32ad82cec073
  33. AU480, AU680 Chemistry Analyzers
  34. Obtryx System and Obtryx II System with Precision Blue
  35. P2, P4, P3B, P4B Plates for the PK7200 and PK7300 Automated Microplate System
  36. CASE / CardioSoft Cardiac Testing System
  37. FIRST Femur Cemented
  38. OEC IT3000; IT2500 (EnTrak); IT2500 Plus (Entrak Plus); IT3500 (InstaTrak)
  39. Synchro2 Guidewire with Hydrophilic Coating
  40. Different Surgical Drivers / extractors
  41. MultiDiagnost Eleva
  42. Similasan Halsweh Lolli
  43. SECTIO SET
  44. b31e762e-2feb-d22e-2717-677fad967f41
  45. Recall of 034.055va T-sleeves Lot R9483
  46. Safety Notice for the iVascular iVolution Self-Expanding Peripheral Stent System, LVD…
  47. Lot / batch recall of ORBITARIS handle, Günter Bissinger Medizintechnik GmbH
  48. Corrective action for the RIA Unconjugated Estriol Kit, Beckman Coulter
  49. Recall for Avidia Angiographic Contrast Injector, Imaxeon
  50. Safety Information for the product minisart (Exchange of mislabeled packages from lot…
  51. Potential pacing inhibition with PARADYM ICDs, Sorin Biomedica CRM S.r.I.
  52. Edwards Lifesciences: Recall for the Fem-Flex II™ Femoral Access Cannula sizes 8, 10, 12…
  53. Urgent Field Safety Notice for Pre-Bypass Filter by Maquet Cardiopulmonary GmbH
  54. Urgent Field Safety Notice for Oracol+ Saliva Collection Device by Malvern Medical…
  55. Safety alert for Lactosorb L Template, Biomet
  56. Recall of a limited number of the automated external defibrillators (AEDs) HeartStart FRx…
  57. Safety Notice for the ACUSON X700 ultrasound systems, Siemens
  58. Recall of StrataMR adjustable valves & shunts, Medtronic GmbH
  59. Field Safety Notice concerning LIFEPAK 20/20e defibrillator/monitor, Physio-Control, Inc…
  60. Urgent Field Safety Notice for LifeStream Balloon expandable vascular Covered Stent by…
  61. Urgent Field Safety Notice for Insulinpumpe der MiniMed 600- und 700-Serie by Medtronic…
  62. Field Safety Notice for Certain GE Responder 2000 Defibrillators, Cardiac Science…
  63. Urgent Field Safety Notice for VIDAS High Sensitive Troponin I by bioMérieux S. (Marcy…
  64. Recall of Disposable Twist Drill from Biomet 3i
  65. Safety Notice concerning an anomaly involving the 4D Integrated Treatment Console and…
  66. Safety Notice for the Intuitive Surgical 5mm Curved Cannula for Single-Site™ Instruments…
  67. Urgent Field Safety Notice for Capture R Ready-ID by Immucor, Inc.
  68. Recall of Polystan pO2-Polytroden from Maquet
  69. Urgent Field Safety Notice for VITEK 2 Antimicrobial Susceptibility Test Kit by BioMérieux…
  70. Recall of Clearview hCG (lot number HG0050) from Unipath
  71. Follow-up information for ARCHITECT c8000, Abbott
  72. HealthcareRisk of the Ohmeda Medical Giraffe Spot Lite Phototherapy Lights from GE…
  73. Recall of GGT/IFCC Granulate System Kits from Roche
  74. Recall for Adapter Stem MML, ESKA
  75. Urgent Safety Notice for the THERMOCOOL® SF NAV Catheters, Biosense Webster
  76. Safety Notice concerning a corrective action of the Zoll E Series external defibrillators…
  77. Lot recall of Hexagonal Driver Medium 1.2, Zimmer Biomet
  78. Urgent Field Safety Notice for PediatrOS RigidTack by Merete Medical GmbH
  79. Information for Ankylos C/X, FRIADENT
  80. Recall for the Aspen/Alpine and Lineum Torque Handles, Biomet Spine LLC
  81. Problems with the ADVANTAGE® Prosthetic Heard Valve from Medtronic
  82. Safety Notice for Lokomat system, Hocoma AG
  83. Recall of intraocular lenses “Ioflex Foldable Intraocular lenses”, Mediphacos Ltda (Belo…
  84. Urgent Field Safety Notice for Lagerungsrolle, -hilfe by Fuhrmann GmbH
  85. Recall of Capillary Caps packed in Safe Clinitubes kits by Radiometer
  86. Safety Notice for Fresenius Medical Care bloodlines, Fresenius Medical Care
  87. Information for gauze products with x-ray thread, Karl Beese
  88. Safety warnings for slings and straps with a D-Ring, Redcord AS
  89. Urgent Field Safety Notice for Bellco MICROPLAS plasmafilters by Bellco S.p.A.
  90. Boston Scientific recalls Tearaway Introducer (Peelable) Sheaths
  91. Urgent Safety Notice for the GLOBAL® APG+ 2,5 mm Breakaway Guide Pin, DePuy Synthes
  92. Corrective action for the FLOW-i C20 - C40 Anaesthesia system, Maquet Critical Care AB
  93. Urgent Field Safety Notice for IMMULITE/IMMULITE 1000/IMMULITE2000/IMMULITE 2000XPi by…
  94. Urgent Field Safety Notice for PL Elastics by FlexMedics
  95. Plus Orthopedics recalls TC-Plus Solution Inserts
  96. Lot Recall for the CoreValve Delivery Catheter Systems (DCS), Medtronic
  97. Safety Notice for the EFK Knee-System, OHST Medizintechnik AG
  98. Recall for angioplastie sets containing a hemostatic Y connector, Smiths Medical
  99. Information for SwitchPoint Infinity 2 & SwitchPoint Element DOM Cards, Stryker
  100. Corrective action for the Kenex ceiling-suspended radiation shields and surgical lamps, GE…
  101. Urgent Field Safety Notice for t-PSA Rapid Test / Free PSA Rapid Test by Dongguan Bosh…
  102. Recall of the products SafePico by Radiometer Medical
  103. Safety Notice for GE Signa OpenSpeed and Ovation MR Scanner, GE Healthcare
  104. Safety Notice concerning the sterEOS workstation, EOS
  105. Corrective action for the Juno DRF System, Philips Medical Systems
  106. Lot recall of BI-20052 Endothelin ELISA, Biomedica Medizinprodukte GmbH
  107. Important Safety Notice for AXIOM Artis, Artis zee or Artis Q systems, Siemens Healthcare
  108. Urgent Field Safety Notice for Lumenis Pulse 120H Holmium Laser Systems by Lumenis Ltd.
  109. Information for SIMVIEW 3000, Simview NT or MEVASIM S, Siemens
  110. Corrective action for BD Microtrol Candida albicans, Becton Dickinson
  111. Recall for Affinis stylus, Mathys
  112. Recall for ARCHITECT Sirolimus Reagent, list no. 01L76-25, lot no. 80162M100, Abbott
  113. Urgent Safety Notice for the product syngo.mMR General VA30, Siemens AG Healthcare Sector
  114. Urgent field safety notice for Pulse Oximeter Probes, Med-Link
  115. Urgent Field Safety Notice for Mueller Hinton E Agar (MHE) by bioMérieux S. (Marcy…
  116. Recall of Expo™ und Impulse™ Angiographic Catheters from Boston Scientific
  117. Recall of the UROVACTM Bladder Evacuator from the manufacturer Boston Scientific…
  118. Urgent Safety Notice for the TIGERPAW System II, LAAx, Inc.
  119. Recall for Medtronic Ablation Frontiers GENius Multi-Channel RF Generators, Medtronic
  120. Information concerning the C-Series Clinac, Varian medical systems
  121. Information for Eclipse, Varian
  122. Safety Information for Coroflex ISAR, B.Braun Melsungen AG
  123. Safety Notice for the Field Generator Stand for the Philips or Traxtal PercuNav system…
  124. Urgent Field Safety Notice for Mobilisations-Reharollstuhl Thekla by Hanse-Medizintechnik…
  125. Recall of Peri-Loc locking screws from Smith & Nephew
  126. Urgent Safety Notice/Corrective action for various GE Healthcare MRI systems, GE…
  127. Urgent Field Safety Notice about a change to the instructions for use/ user's manual…
  128. Recall of all Vega Tibia Extension stems, Aesculap
  129. Recall for Trigen Intertan Nails, Smith & Nephew
  130. Safety Information for corpuls3 defibrillator/monitoring system, GS Elektromedizinische…
  131. Lot Recall for Corail Hip Cemented Femoral Stem Without Collar, DePuy
  132. Safety Advisory Notice for the Axiom Luminos dRF system for fluoroscopy and radiography…
  133. Corrective action for the Accessory Device - Uninterruptible Power Supply (UPS), Philips…
  134. Recall of the lot number 754801F of the Flow-Count Fluorospheres from Beckman Coulter
  135. Safety Notice for Delta and Gamma XXL, Dräger
  136. Corrective action of the Synchron LX20, Synchron LX20 PRO, Synchron LXi 725, UniCel DxC…
  137. Urgent Field Safety Notice for Juno DRF, Philips Medical Systems
  138. Urgent Field Safety Notice for MetaVision Suite, Clinical Information System& EHR by…
  139. Information for G8 Hemoglobin F&A2 Control Set, TOSOH
  140. Stryker recalls the Scorpio Total Knee Replacement System
  141. Information for Innova 2100IQ, 3100/3100IQ und 4100/4100IQ, GE Healthcare
  142. Urgent Safety Notice for Paradym DR 8550, Paradym CRT 8750 and Paradym CRT sonR 8770
  143. Recall for enGen Laboratory Automation Systems configured with Hettich Rotanta 46 RSC…
  144. Urgent Field Safety Notice for ACE BLADDER EVACUATOR by ACE MEDICAL DEVICES PVT LTD
  145. Lot recall of Procedure Pak products, Mölnlycke Health Care AB
  146. Recall for the Gangi Special-Vertebroplasty Needle Set for Cemento-RE, OptiMed…
  147. Urgent Safety Notice for the ADAC Vertex Classic, Vertex Plus, Solus and Vertex V60…
  148. Urgent field safety notice for RHK Knee 16 mm Bearing for 71 mm, 75 mm & 79 mm RHK Tibial…
  149. Recall for the Urethra pessary, size 55mm, Dr. Arabin GmbH & Co. KG
  150. Urgent Field Safety Notice for ADVIA Chemistry XPT System by Siemens Healthcare…
  151. Curative recalls PorticoPorts
  152. Safety Information for the ADVIA Centaur Folate Assay, Siemens Healthcare Diagnostics
  153. Urgent Field Safety Notice for Gas bottle holder for helicopter HKH 8880 by Maquet…
  154. Corrective action for the ADVIA® Chemistry Systems/ADVIA Chemistry Lipase, Siemens…
  155. Recall of Beckman Coulter for the automated pipetting protocol Dil-AFP
  156. Recall of M/DN, HPG II and Herbert Sterile Screws from Zimmer
  157. Lot Recall for Elect balloon catheter, Biotronic
  158. Corrective Action for the 96 DeepWell plates, Siemens
  159. Urgent field safety notice for duodenscopes, PENTAX Europe GmbH
  160. Urgent Field Safety Notice for STA Compact, STA Compact Max, STA-R Evolution, STA-R Max by…
  161. Urgent Field Safety Notice for Flex ventilation hoses by Drägerwerk AG & Co. KGaA
  162. Safety Notice for the Optima MR450w with GEM system, GE Healthcare
  163. Urgent Field Safety Notice for recomScan Software (BLOTrix System) by Mikrogen GmbH
  164. Urgent Field Safety Notice for MAGEC Spinal Bracing and Distraction System by NuVasive…
  165. Information for Injectomat syringe, Fresenius Kabi
  166. Recall for the Versant Sample Preparation 1.0 Reagents, Siemens
  167. Urgent Field Safety Notice for Artis zeego & Artis zee/Q./Q.zen by Siemens Healthcare GmbH…
  168. Information for the hospital beds Comforta from the company Joh. Stiegelmeyer
  169. Safety Notice for Lens Cleaning Sheath MAJ-1537 useable with LTF-VH, Olympus
  170. Recall for Antireflux Valve Ureteral Stent Sets for Children, Teleflex Medical
  171. Safety Notice concerning a problem with the MRU of certain MRI Systems, GE Healthcare
  172. Recall of the CORE Powered Instument Driver from Stryker
  173. Recall for HemoStat Thromboplastin-SI, Human
  174. Plus Orthopedics recalls the TC-Plus Solution tibial components
  175. Corrective action for the AXIOM Aristos FX systems, Siemens AG
  176. Safety risk of care beds from Deeken Reha & Objekt
  177. Operator's guide change Orchestra Base Primea Datenmanager, Fresenius Vial
  178. Safety Notice for the AQURE system, Radiometer
  179. Corrective action of the AxSYM Quinidine Standard Calibrators, AxSYM Quinidine Controls…
  180. Safety Notice for GE Anesthesia Devices, GE Healthcare
  181. Urgent Safety Notice for the CryOmega® Multi-Use Disposable Cryosurgical Device…
  182. Urgent Field Safety Notice for Heater-Cooler Unit HCU 40 by Maquet Cardiopulmonary AG
  183. Urgent Field Safety Notice for OF-03-01-0038 by Leica Microsystems (Schweiz) AG
  184. Safety Notice for Acrobat 2000, Ondal Industrietechnik GmbH
  185. Corrective action on Sola 300 from Dräger
  186. Safety Notice for the Breas Medical AB Homecare Ventilator Model Vivo 40, GE Healthcare
  187. Recall of the software of ACL Futura and ACL Advance systems, Instrumentation Laboratory
  188. Corrective action for Waters Acquity TQD, SQD and 3100 Mass Spectrometers, Waters
  189. Recall of the Dyonics Electroblade and Trivex products from Smith & Nephew
  190. Lot Recall for the Valor® Targeting Guide and the Valor® TTC Fusion Instrument Set, Wright…
  191. Recall of the software of the ACL Top system, Instrumentation Laboratory
  192. Safety Notice concerning the usage of SERVO-i and SERVO-s Ventilator Systems during…
  193. Biosense Webster recalls the Celsius® ThermoCool® and NaviStar® ThermoCool® irrigated…
  194. Urgent Safety Notice for the product 11-Desoxycortisol-RIA-CT, DIAsource ImmunoAssays S.A.
  195. Corrective action and recall of the ABL80FLEX Analyzers (software version 1.10) from…
  196. Recall for VaxcelTM Port and VaxcelTM Port with PASVTM Valve, Navilyst Medical Inc.
  197. Corrective action for the ADVIA Centaur® XPT System, Siemens Healthcare Diagnostics
  198. Terumo recalls the Sarns Retrograde Cardioplegia Cannulae
  199. Recall of certain lots of the Easy Cyst Suprapubic Exchange Set for Children, Teleflex…
  200. Safety Notice for Integra Cusa NXT Ultrasonic Tissue Ablation System, Integra Life…
  201. Refitting of the patient hoists model Minerva from Arjo
  202. Recall of the Ureteral Stent Set by Urotech
  203. Recall for the STA Cephascreen 4 reagent from the manufacturer Roche
  204. Safety Notice for the LenSx® Laser System, Alcon Pharma GmbH
  205. Safety Notice for OrthoPAT devices, Haemonetics
  206. Recall of X-ray silicon drains CH 24/ 50 cm from Microtec Medical
  207. Lot Recall for Foliodrape® protect plus Angiography Set I, Paul Hartmann AG
  208. Urgent Safety Notice for the NovaGold™ Guidewire, Boston Scientific
  209. Urgent Field Safety Notice for GXT NA Extraction Kit by Hain Lifescience GmbH
  210. Information concerning the modification of software version 4.29 and the renal replacement…
  211. Recall for the Retrograde Cardioplegia Cannula, ANDOCOR n.v.
  212. Safety Notice for INNOTEST ß-AMYLOID(1-42), Innogenetics
  213. Recall for OtisMed ShapeMatch Cutting Guides, Stryker
  214. Recall for PALL High Efficiency In-Process Filter System for Leucocyte Removal from Pooled…
  215. Corrective action for OPTI CCA-TS, OPTI CCA-TS2 , OPTI CCA and OPTI-R analyzer, OPTI…
  216. Corrective action of ADVIA Centaur, Centaur XP and Centaur CP in combination with the…
  217. Safety Notice for Delphin rear wheels, Sunrise Medical
  218. Field Safety Notice concerning Navigation, StealthStation S7 Power Cord Retractor…
  219. Safety Notice for the Lipase Reagent, Abbott Laboratories
  220. Urgent Field Safety Notice for HEMASHIELD PLATINUM Woven Double Velour by InterVascular…
  221. Lot Recall for the Brillant Mouth Mirror, HAGER & WERKEN
  222. Urgent Field Safety Notice for VNS Therapy SenTiva Generator by LivaNova, Inc
  223. Safety Notice for Signa MR 3 T systems, GE Healthcare
  224. Recall of Becton Dickinson for the BD ProCOUNTTM Progenitor Cell Enumeration Kit
  225. Safety Alert for the Gambro Prisma Continuous Renal Replacement System
  226. Safety Notice on implantable pulse generators for neurostimulation Brio, St. Jude Medical
  227. Recall of certain lots of two products (Pipeline Embolization Device and Alligator…
  228. Corrective action of Brain Heart Infusion Broth TV5010D, Oxoid
  229. Recall for Endoloop Ligature PDS II Suture, Johnson & Johnson
  230. Urgent Field Safety Notice for elisa 300, elisa 500, elisa 600, elisa 800 und elisa 800VIT…
  231. Urgent Field Safety Notice for Acuson Sequoia by Siemens Medical Solutions USA, Inc…
  232. Medical Device
  233. Recall for GEHC 1.5 m and 1.8 m Uni-Circuit anesthesia breathing circuits, GE Healthcare
  234. Urgent Safety Notice for the Tetanos Quick Stick TQS®, Gamma Diaxonhit Groupe
  235. Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB
  236. Information for MX 4000, MX 4000 Dual and MX 6000 Dual CT scanners, Philips
  237. Lot recall of ADVIA Chemie Triglyceride-Reagent (TRIG_c), Siemens Healthcare Diagnostics…
  238. LASEREDGE Trapezoidal Knife
  239. Giraffe OmniBed Carestation
  240. BCS XP System
  241. Recall of special lots of the 8F Bard® Channel Steerable Sheath from the manufacturer…
  242. Information for Engström Carestation, GE Healthcare
  243. Safety Notice for exudates collection pouches (1000 ml, Ref 25294) with Suprasorb CNP P1…
  244. Urgent field safety notice for natural rubber products / Papoose cervical orthoses for…
  245. Batch recall of PANTA / XL nails, Integra / Newdeal
  246. Urgent Field Safety Notice for DR-XD 1000 / FDR Nano by FUJIFILM Corporation
  247. Exchange of the remote control in wheelchairs model Neo and Elyps from Bischoff & Bischoff
  248. Important Safety Notice regarding the CelonProSurge Bipolar Coagulation Electrode, Olympus
  249. Information for INCOR, Berlin Heart GmbH
  250. Safety Notice for CT Perfusion 4, GE Healthcare
  251. Lot-recall regarding Sorbit-MacConkey-Agar with MUG
  252. Recall for the MBR-2-FEHLING Aortic Deairing Cannulae, Fehling Instruments
  253. Information for PO5076A Cetrimide Agar, Oxoid
  254. Urgent safety notice concerning a shipment of products for endoscopy and urology by Boston…
  255. Safety Notice for the product “MRS Traverse Switch,” a component of the Molift Rail System…
  256. Urgent Field Safety Notice for ExcelsiusGPS by Globus Medical, Inc.
  257. Lot recall of dialysis blood tubing system, B.Braun Avitum AG
  258. Urgent Safety Notice for the Revaclear 400 dialyzers, Gambro Dialysatoren GmbH
  259. Further Information/Corrective action for the T2100 and T2000 Treadmills, GE Healthcare
  260. Urgent field safety notice for G5 and S1 ventilators, Hamilton Medical AG
  261. Corrective action for COBAS INTEGRA 400/400 plus, Roche
  262. Corrective action for the T2100 Treadmill (Uncontrolled Walking Belt Motion), GE…
  263. Information for FRED Easyport Defibrillator, Schiller
  264. Corrective action and recall for Perox Sheath Filter, Siemens
  265. Recall of DYONICS 25 Tube Sets, Smith & Nephew
  266. Corrective action for the PROFEMOR® Modular Neck Extraction Plug - long and short…
  267. Corrective action for the Magellan Robotic System, Hansen Medical Inc.
  268. Urgent Field Safety Notice for xTAG Gastrointestinal Pathogen Panel (GPP) by Luminex…
  269. Error in the CustomCornea® software of the LADARVision4000® Excimer Laser System from…
  270. Recall for Plasmacell-C Disposable Sets, Fenwal
  271. Corrective action for the IMMULITE®/IMMULITE® 1000 Thyroxine-Binding Globulin, Siemens…
  272. Recall of intrathecal catheters model 8731 and distal revision kits for intrathecal…
  273. Recall of umbilical cord clamps from the manufacturer Changshu Selin Medical Appliance
  274. Corrective action for the ExacTrac 6.x Patient Positioning System, Brainlab AG
  275. Urgent Field Safety Notice for Soluscope Serie 4 by Soluscope S.A.S.
  276. Corrective action of Abbott for Clinical Chemistry Bilirubin Calibrator
  277. Lot Recall for the Duisburg Hollow Screw for Subdural Puncture, TELEFLEX
  278. Corrective action for the Manual Collimator Exchange system in use with an ADAC Vertex…
  279. Olympus Europa SE & Co. KG SG PK CUTTING FORCEPS, 5MM, 33CM Olympus - tagasikutsumine…
  280. Safety Notice for HeartStart FR2+ automated external defibrillators (AEDs), Philips
  281. Urgent Field Safety Notice for 4G LATITUDE MIMIC Cell Adapter 6227 for LATITUDE…
  282. Urgent Field Safety Notice for Glace Custom Made CMF Implant by Skulle Implants…
  283. Advisory Notice for the Nikkiso Blood Tubing Lines for Hemodialysis, Nikkiso
  284. Urgent Field Safety Notice for BIP O-Twist-Marker SRX by BIP Biomedizinische Instrumente &…
  285. Lot Recall for the NovaFlex Delivery System, Edwards Lifesciences
  286. Urgent Safety Notice for the Fraxel DUAL 1550/1927 Laser System, Solta Medical Inc.
  287. Urgent Field Safety Notice for DD Prefab DFX 38 / 45 / 55 Set by Dental Direkt GmbH
  288. Recall for Gyrus one piece electrode, DePuy Mitek
  289. Urgent Field Safety Notice for Affinity Pixie Oxygenator und Kardiotomiereservoir /…
  290. Correction of the LeVeen™ Needle Electrode from Boston Scientific
  291. Safety Notice for the ExacTrac 5.5.5 Patient Positioning System, Brainlab AG
  292. Safety Notice concerning undesired positioning tolerances for high-dose treatments, Varian…
  293. New reprocessing instructions for the OLYMPUS model TJF-Q180V Duodenoscope, Olympus…
  294. Recall of the Premier Edge MVR 19g Knife and the Premier Edge MVR 20g Knife from OASIS…
  295. Information for Detacha Tip, ConMed
  296. Corrective action for the VITROS® 5,1 FS Chemistry System, Ortho-Clinical Diagnostics…
  297. Urgent Field Safety Notice for Paragon Oxygenator by Chalice Medical Ltd
  298. SYNCHRON System Immunoglobulin A (Ig-A) Reagent
  299. Field safety notice concerning malfunction when using syngo plaza with version VA20…
  300. Nicolet Elite Probe
  301. Safety Notice for Essenta DR Compact X-ray systems, Philips
  302. Corrective action for the Herbst® Appliance made with Universal Nuts, Specialty Appliances
  303. Field Safety Notice of the device Dynesis Top Loading Spacer Cutter
  304. Urgent Field Safety Notice for Ysio by Siemens Healthcare GmbH, X-Ray Products (XP)
  305. Urgent Field Safety Notice : Accu-Chek® Compact test strips as well as Accu-Chek® Mobile…
  306. Recall of the Impulse™ Agniographic Catheters from Boston Scientific
  307. Safety Notice for the COLLEAGUE Volumetric Infusion Pump, Baxter
  308. Urgent Field Safety Notice for ECG trunk cable by GE Healthcare Finland Oy
  309. Urgent Field Safety Notice for balanSys UNI convex PE inlays x/6, x/7, x/9 by Mathys AG…
  310. Urgent Safety Notice concerning gradient coil electromechanical connections associated…
  311. Safety Notice for Alaris GP Volumetric Pumps and Alaris GP Guardrails Volumetric Pumps…
  312. Lot recall of Covidien Curity All Purpose Gauze Sponges / Curity X-Ray Detectable…
  313. Urgent Field Safety Notice for CALEX Cap by Bühlmann Laboratories AG
  314. Recall of Powersail Coronary Dilation Catheters
  315. Recall of the artificial urinary sphincter “AMS 800 Urinary Control System”, AMS
  316. Safety Notice for the 4D Integrated Treatment Console (4DITC), Varian medical systems
  317. Safety Notice for the MODULAR ANALYTICS <E 170>, MODULAR ANALYTICS EVO <E 170>, cobas e…
  318. Corrective action for the 5.5-50 mm Continuous Radius Rods, X-spine Systems, Inc.
  319. Information for the syringe pump IVAC P4000 from Cardinal Health Alaris Products…
  320. Recall for the artificial anal sphincter Acticon Neosphincter, AMS
  321. Recall of BD Plastipak Syringe 100 ml with catheter neck, MSP Schmeiser GmbH
  322. Lot Recall of the genitourinary graft Elevate Pelvic Floor Repair Systems with IntePro…
  323. Issue with the patient table of the MAGNETOM from Siemens
  324. Corrective action of the m2000sp und m1000 analyzers from Abbott
  325. Security advice for SlimFlex-m 1.2.3, PhysIOL
  326. Urgent Field Safety Notice for Laguna Badewannensitz by RUSSKA - Ludwig Bertram GmbH
  327. Recall for GlucoTalk test strips of Progen
  328. Lot recall of Tacrolismus (TACR) Flex Reagent Cartridges (DF 107), Siemens
  329. Follow-up Information for the SynchroMed® II Implantable Drug Infusion Pump, Medtronic
  330. Urgent field safety notice for Prismaflex, Baxter International Inc.
  331. Corrective action for Clinical Chemistry from Abbott
  332. Safety Notice concerning corrective actions for X-ray system VIDIX U (Universal Type)…
  333. Safety Notice for the Orthoralix 8500 DDE and the Orthoralix 9200 DDE Panoramic Dental…
  334. Recall of ETHICON VICRYL™ Suture, Johnson & Johnson International
  335. Urgent Field Safety Notice for TULIPS by Ardo medical AG
  336. Recall of Drill stops of RS/RSX-Line 3.0 from Drill stop TrayPlus RS/RSX-Line, BEGO…
  337. Important Information: Exchange program of specific V-Sign™ Sensors 2, SenTec AG
  338. Recall of Syncro™-14 und Syncro²™ Guidewires
  339. Safety Notice for the device L-Varlock Instrument/ Implant box, KISCO International
  340. Urgent Field Safety Notice for GelPOINT® Path Transanal Access Platform by Applied Medical…
  341. Recall of UnBalloon Non-Occlusive Modeling Catheters, LeMaitre Vascular Inc.
  342. Urgent Safety Notice for the syngo Imaging system, Siemens AG
  343. Corrective action for the cobas b 123 POC system, Roche Diagnostics GmbH
  344. Exchange of the spreader in patient hoists Arnold from Rebotec
  345. Corrective action for the Exceed ABT Spring Loaded Impactor, Biomet UK Ltd.
  346. Becton Dickinson recalls the BD CritiFlo and CritiFlo kits
  347. Recall ultrasound and ECG gels, Tyco Healthcare
  348. Information concerning the Brilliance 40/64 CT system from Philips
  349. Corrective action for ACCU-Chek Performa Test Strips, Roche
  350. Perouse Laboratoires recalls POLYSHUNT®
  351. Urgent Field Safety Notice for SIGNA Prime by GE HEALTHCARE (TIANJIN) COMPANY LIMITED
  352. Recall of the Targon PF bone nails from Aesculap
  353. Recall of Focus® Dailies® Toric soft contact lenses by Ciba Vision
  354. Recall for Reflex Revision Screwdriver, Stryker
  355. Important Information for the Hemolytic system for CFT, Labor Dr. Merk & Kollegen GmbH
  356. Recall of the CORDIS SV-5 and SV-8 Peripheral Steerable Guidewire
  357. Safety Notice for the Alegria® Anti-Intrinsic Factor assay (ORG 247-24), ORGENTEC…
  358. Urgent field safety notice for Aisys CS2 and upgraded Aisys devices, GE Healthcare
  359. Medtronic recalls the Midas Rex Classic, GS and Legend within 2 phases
  360. Information for IMPAX Client 6.x, Agfa
  361. Safety Notice: Problem with Instrument tables IT01 for Perimeter Octopus 300 and IT02 for…
  362. Conterfeits of the Accu-Check Softclix lancets from Roche
  363. Recall of certain lots of Celsite access portsystems with polyurethane catheter
  364. Corrective action on anaesthesia systems from Draeger
  365. Safety Notice for the Legendair ventilator, Covidien
  366. Safety Notice for the product TAP Kerrison, Gebrueder Zepf Medizintechnik
  367. Recall of one charge of Comfort Handles with HF-Connection 8393,0004 from Richard Wolf
  368. Safety Notice for the Optical Guidance Platform, Varian medical systems
  369. Safety Notice / Lot Recall for the products DRYSTAR DT2 MAMMO and DRYSTAR DT5.000I MAMMO…
  370. Urgent Field Safety Notice for BS 3/8x3/32 L1.7 by Maquet Cardiopulmonary GmbH
  371. Urgent Field Safety Notice for BiMobile Dual Mobility System, Liner by Waldemar Link GmbH…
  372. Information concerning an update of the WaveScan WaveFront software to version 3.671 from…
  373. Safety Notice for Thermo Scientific Microm STP 420D, Microm International
  374. Safety Information regarding COBAS® AmpliPrep/COBAS TaqMan® system using AMPILINK software…
  375. Corrective action for Flow-Set Fluorospheres, Beckman Coulter
  376. Recall for GlucoHEXAL ® II strips, Medwatch GmbH
  377. Safety Notice for MultiDiagnost Eleva II, Philips
  378. Recall of the NEWAY DR pacemakers from Sorin
  379. Safety Notice for HI Art treatment system, TomoTherapy
  380. KayserBetten informs how to avoid the unauthorised operation of the electric adjustment…
  381. Return of Baha Soft Tissue Gauge 6 mm, Cochlear
  382. Information concerning possible under delivery of enteral products from Abbott
  383. Corrective action for Synchron LX20, LX20 Pro and LXi725 Clinical Systems, Beckman Coulter
  384. Urgent Safety Notice for the Infant Nasal CPAP Prongs, Fisher & Paykel Healthcare Limited
  385. Corrective action of the Lifepak 500 automated external defibrillators from Medtronic
  386. Safety Notice for External Pulse Generators PACE 203H, PACE 300 and Model 3085, Osypka…
  387. Corrective Action / Recall for Unicel DxH 800 Coulter Cellular Analysis System, Beckman…
  388. Urgent Field Safety Notice for EXTREME monobloc Epiphyseal-Metaphyseal with HAP by…
  389. Urgent Field Safety Notice for Dialog iQ by B. Braun Avitum AG
  390. Urgent Field Safety Notice for FITBONE by Wittenstein intens GmbH
  391. Safety Notice concerning specific serial numbers of CT System Brilliance iCT…
  392. PreciControl Varia
  393. Recall for Loglysis-catheter for intravascular treatment, OptiMed
  394. New manuals for the Non-Temperature Sensing Ablation Catherters from Biosense Medical
  395. Urgent Field Safety Notice for Tri-Staple 2.0 by Covidien llc
  396. Urgent field safety notice for Osseofix sterile package implant 5.5 mm, Alphatec Spine…
  397. Urgent Field Safety Notice for Quantum Perfusion Centrifugal Blood Pump with Int. by…
  398. Recall Thromboquik Reagent, Trinity Biotech
  399. Safety related change of the user manual of the Legendair ventilator from Tyco Healthcare
  400. Batch recall of Revitan proximal spout stems (Size 55-105) and Revitan proximal…
  401. Recall Leptospira Serology Kit, Bio-Rad Laboratories
  402. Recall of Fuse 1C Colonoscopes, EndoChoice Inc.
  403. Urgent Field Safety Notice for Innex by Zimmer GmbH
  404. Recall of the Groove Power Wheelchairs with Quickie Enhanced Display from Sunrise Medical
  405. Urgent Field Safety Notice for Alinity s System by Abbott Laboratories, Inc.
  406. Elefant - Suction-irrigation device
  407. Nemio and Nemio XG
  408. Field Safety Notice Monthly Summary Sheet - May 2012
  409. Teleflex ET tube connector - 15mm ühenduse kinnitusprobleemid
  410. Incorrect translation in the instruction for use of the cot 6100 M1 from Stryker
  411. Information for the Gambro Prismaflex™ Continuous Renal Replacement System
  412. Recall of two batches of the Neumann Titan Arthrodesis Plate Proximal, Zimmer GmbH on…
  413. Lot recall of Medivance ARCTICGEL Pads, Bard Limited
  414. Recall for BBL Streptocard Acid Latex Kit, Becton Dickinson
  415. Recall for ventricular catheter, Christoph Miethke GmbH CO KG
  416. Urgent Field Safety Notice for Disposable Bipolar Ablators by Bovie Medical Corporation
  417. Urgent Field Safety Notice for Infusomat Space Line Type Transfusion by B. Braun Melsungen…
  418. Lot Recall for Intrafix Primeline, B.Braun Melsungen AG
  419. Lot recall of NQ527-Columbus CR/PS Trial Gl.Surf. T2/2+ 14mm in Columbus Set Basic Tibia…
  420. Safety Notice for Advantage Workstation Thoracic VCAR application software, GE Healthcare
  421. Siemens is not aware of compatibility test for MR Scans with Tx/Rx Head MR Coil for…
  422. Additions to the Instructions for Use for the Recovery® G2 Filter from BARD
  423. Corrective action for Vitros Chemistry Products VALP Reagent, Ortho Clinical Diagnostics
  424. Urgent field safety notice for ROTEM sigma complete + hep cartridge (Art. No. 555502)…
  425. Corrective action for the Nova Stat Strip Glucose Hospital Monitoring System, Nova…
  426. Safety Notice for the MultiDiagnost Eleva FD X-ray system, Philips
  427. Urgent Field Safety Notice for Atellica CH Ethyl Alcohol by Siemens Healthcare Diagnostics…
  428. Recall for Viewsonic VG930M, Welch Allyn
  429. Urgent Field Safety Notice for ZNN BACTIGUARD Retrograde Femoral Nail by Bactiguard (South…
  430. Safety Notice for Arjo Carendo Multipurpose Hygiene Chair, Arjo Hospital Equipment AB
  431. Corrective action for Synchron Systems Calibrator 1, Beckman Coulter
  432. Lot recall of Guardian II Hemostasis Valve, model numbers FH101, FH101-T, FH101-25 und…
  433. Wright Medical Technologies recalls the Conserve Plus acetabular components
  434. Lot recall of Hemochron Jr. PT Cuvettes, International Technodyne Corporation (ICT)
  435. Recall for Immulite 2500 STAT iPTH, Siemens
  436. Recall for SoftGrip Manual Pipette, Hamilton Bonaduz
  437. Lot Recall for Heartstring Aortic Cutter 4,3 mm, Maquet
  438. Lot Recall for the Passeo-18 balloon catheter, Biotronik
  439. Information for Motiva Remote Patient Management System, Philips
  440. Safety Notice regarding the CARA i-Butment Titan T00 device, HERAEUS KULZER
  441. Urgent Field Safety Notice for Spine & Trauma 3D by Brainlab AG
  442. Corrective action and recall from Emergo Europe for i-Stat G3+ Cartridges
  443. Recall NexStent Carotid Stent, Boston Scientific
  444. Recall of the Silikon-Penrose Kapillar Drain, Roeser Medical GmbH
  445. Important Information for the Accu-Chek® Spirit Combo insulin pump, Roche Diagnostics
  446. Urgent Field Safety Notice for Syringes with Sodium Chloride 0,9% by Steripack SA
  447. Batch recall of TC-PLUS Primary Fixed Tibial Components VKS (cemented and non-cemented)…
  448. Urgent Field Safety Notice for ED-FLOW, ED-FLOW S. by Getinge Disinfection AB
  449. Recall for Precision Xtra Plus Blood Glucose Test Strips, Abbott
  450. Urgent Field Safety Notice for HiRes Ultra / HiRes Ultra 3D by Advanced Bionics AG
  451. Safety Notice for Cirrus™ HD-OCT Models 4000 and 400 with Instrument and Review Software…
  452. SWISS optio terminal unit DIN
  453. Medtronic recalls the DLP VAD Cannula for Ventricular Assist and the Cardio Kits C390601A…
  454. Information concerning the Ximatron Digital Imaging v7.5.51 mit Service Pack (SP) 2 from…
  455. Safety Notice concerning OR-Table-System OTESUS 1160.01, Maquet GmbH
  456. Urgent Field Safety Notice for Raymat AS1 by Raymed Imaging AG
  457. Urgent Field Safety Notice for Combihesive and Natura by ConvaTec Limited Deeside
  458. Recall of defibrillation electrodes, Leonhard Lang
  459. Urgent Safety Information: Exchange of actuators from Linak for care beds , Hermann Bock…
  460. Recall of special lots of the central venous catheter LogiCath AgTive and packs containing…
  461. Corrective action of the Flex One Suction Hard Canister CF0200 from Cardinal Health
  462. Safety Notice for Optical Guidance Platform used for Clinac® or Novalis®TX machines…
  463. Urgent Field Safety Notice for CELL-DYN Emerald by Abbott Laboratories
  464. Urgent Field Safety Notice for Ultra Clean Plus Surface Disinfection Lemon 5L by CB…
  465. Actions against possible breakage of push handle fixing in wheelchairs model Emineo from…
  466. Siemens AG: Safety Notice for the syngo Workflow MLR - "Portal Radiologist"
  467. Urgent field safety notice for software ClinicWinData version 8.04.52, E&L medical systems…
  468. Safety Information for LiRASTM for Infectious Diseases, Innogenetics
  469. Safety advice for the Modular Plus system from Plus Orthopedics
  470. Recall Covator Arthro Wand with Integrated Cable Wand, ArthroCare
  471. Safety Corrective Action concerning FLOW-i anaesthesia system, Maquet
  472. Urgent Field Safety Notice for FTD Fever and rash by Fast Track Diagnostics Luxembourg…
  473. Information for VARiS Vision / System 6.5, Varian
  474. Urgent field safety notice for EB010 - Voyant 5mm Fusion / 37mm 6NE, Applied Medical
  475. Urgent Field Safety Notice for ADVIA Chemistry Enzyme 2 Calibrator by Siemens Healthcare…
  476. Recall of extension sets from Cardinal Health
  477. Urgent Field Safety Notice for COROFLEX ISAR NEO 2.25 X 24 MM by B. Braun Melsungen AG…
  478. Recall for Ambix Intraport CP, Fresenius Kabi
  479. Safety Notice for Kolibri Navigation Station 2.0, BrainLAB
  480. Medtronic is replacing older version QUIK-COMBO pacing/defibrillation/ECG cables and…
  481. Arrow International Inc.: Urgent Safety Notice for the PSI Kits, Multi-Lumen/PSI Kits and…
  482. Safety Notice for Lifepak 15 Monitor/Defibrillator, Medtronic
  483. Urgent Field Safety Notice for AK 95, AK 96, AK 98 by Gambro Lundia AB
  484. Recall of the DORADO CT-3 of CT-4 Patient Alignment System of LAP
  485. Safety Notice for WaveScan WaveFront Systems and Offline Programming Module (OPM), AMO
  486. Leakage of the transfer bag from MacoPharma
  487. Recall Livewire TC, St. Jude Medical
  488. Recall of the Oscillating Saw Attachment for Colibri / Colibri II / Small Electric Drive…
  489. Recall of Dimension Creatine Kinase CK-MB mass isoenzyme (MMB) from Dade Behring
  490. Corrective action for the Kryo range of freezers, Planer plc
  491. Recall of BioMerieux for Mueller-Hinton 2 + 5 % sheep blood agar
  492. Urgent Field Safety Notice for RESOLVE HALO by Össur hf.
  493. Lot recall of 6 Fr. Engage™ Introducers, St. Jude Medical
  494. Safety Notice for Völker nursing beds, Völker GmbH
  495. Recall of the hip stems VerSys, Trabecular Metal, Mayo Conservative and ZMR from Zimmer
  496. Recall AL6B, Pall Medical
  497. Information for Super Elastic Self-Crimping Nitinol Piston, AUDIO TECHNOLOGIES
  498. Recall of the Molina PinDriver model number 51-600-85, Gebrüder Martin GmbH & Co. KG
  499. Exchange of the cross tube in carriage model 4002 from Stollenwerk
  500. Recall for Columbia CNA Agar with 5% Sheep Blood, Improved II, Becton Dickinson
  501. Recall for New NBP cuffs neo, Dräger
  502. Recall of microkeratome devices Zyoptix XP Epi Separator and Zyoptix XP Epi Head of the…
  503. Recall for orthopaedic shoes, Johannes Herges GmbH
  504. Updated Safety Information for the Cordis RENLANE™ Renal Denervation Catheter, Biosense…
  505. B.Braun/Aesculap recalls Endoscopy Trolleys
  506. Possible inadvertent deletion of accessory elements (including dynamic MLC) in VARIS…
  507. Safety Notice for the Magnus 1180.16Ax, 1180.16Fx and T285.7000 carbon-fibre table tops…
  508. Corrective action for Dimension® Clinical Chemistry Systems Dimension TACR Flex reagent…
  509. Corrective action of Roche for COBAS Ampliprep/COBAS TaqMan tests
  510. Recall of the 200 ml disposable syringes manufactured by Nemoto Kyorindo
  511. Recall for Dyonics Power Shaver Blades, Smith & Nephew
  512. Safety information regarding the Coiled-Tube INFUSOR system, Baxter
  513. Urgent field safety notice for lithomy basket series "Easy-Catch", MTW-Endoskopie
  514. Replacing of power boards of LTV 900, LTV 950, and LTV 1000 ventilators from Pulmonetic
  515. User Information for the Lifepak 500 AED from Medtronic

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