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International device safety notices

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

  1. User Information for the Lifepak 500 AED from Medtronic
  2. Safety Notice for Olympus ETD / Olymus miniETD, Miele & Cie. KG
  3. Urgent Safety Notice / Recall for the Fem-Flex II™ arterial cannula sizes 16, 18 and 20…
  4. Urgent Field Safety Notice for Pericardiocentesis Kit by Merit Medical Systems Inc.
  5. Recall ARCHITECT Total ß-hCG Calibrators, Abbott
  6. Recall of LEVO C³ starting with serial number 913..., LEVO AG
  7. Collision risk when lowering table height of Ysio, Siemens Healthcare
  8. Safety Notice for the Thermablate EAS System, Idoman Teoranta
  9. Urgent Field Safety Notice for CORAIL2 STD SIZE 12 by DePuy France SA
  10. Information for Essenta DR, Philips
  11. Follow-up Information for the Access 2 Immunoassay Systems and UniCel DxI Immunoassay…
  12. Recall for several products for inhalation therapy, Teleflex Medical
  13. Urgent Field Safety Notice for MATCH IT! DNA software by immucor GTI Diagnostics, Inc.
  14. Urgent Field Safety Notice for Jobst Compri2 / Jobst Compri2 Lite by BSN medical GmbH
  15. AGA Medical recalls AMPLATZER® Vascular Plug
  16. Urgent field safety notice for ELITE, Heavy Duty and Footed attachments, Stryker GmbH &…
  17. Corrective action affecting Ventak Prizm 2 DR. model 1861 manufactured by Guidant Corp.
  18. Recall regarding Operating Table TruSystem 7500 / ARTIS, Trumpf Medizin Systeme GmbH + Co…
  19. Corrective action for ultraView Universal DAB Detection-Kit and iView Universal DAB…
  20. Recall for intragastric balloons HELIOSPHERE, HELIOSCOPIE
  21. Corrective action for the Fem-Flex II Femoral Arterial Cannulae, Edwards Lifesciences…
  22. Urgent Field Safety Notice for Inferior Vena Cava (IVC) Filter by William Cook Europe ApS
  23. Safety notice for Revolution XR/d X-ray systems, GE Healthcare
  24. Corrective action affecting the iBEAM and Imaging carbon fibre tabletops from Medical…
  25. Safety Notice for HiRes 90k Implant Magnet, Advanced Bionics
  26. Safety Notice for the detachable APART-Punches (Punches Fitted with Button), Fehling…
  27. Recall of the Universal Sling Bar with the product numbers 3156075, 3156085 and 3156095…
  28. Field Safety Notice concerning XLT wheel chairs, Invacare Rea AB
  29. Safety Notice for EM 2400 Compounder, Baxa
  30. Safety Notice for Rückenmaschine med, Milon Industries
  31. Important Safety Information for the elastomeric infusion pump system FOLFusor SV 0,5…
  32. Lot recall of Fetal Scalp Blood Sampler, LiNA Medical ApS
  33. Information for Oncentra MasterPlan, Nucletron
  34. Safety Notice for Contasure Needleless, DIMA
  35. Quality problem with the height adjustable pushhandles on Action4 from Invacare
  36. Corrective action for EP-FIT PLUS/MPF Ceramic Insert Deltas, Smith & Nephew, Inc.
  37. Safety Notice for Clearview HCG, Unipath
  38. Safety Notice for wheeled ambulance stretcher model 6100 M1, Stryker
  39. Corrective action for detachable instruments fitted with button, CEATEC Medizintechnik…
  40. Risk with the wheelchairs Typhoon and Tornado from Invacare
  41. Recall of circular stapler and hemorrhoidal stapler by Stapleline Medizintechnik
  42. Safety Notice for NX software with CMS option, Agfa HealthCare
  43. Information about pelvic belt at the Invacare Rea wheelchairs of the company Invacare…
  44. Lot recall of Vivano Med Abdominal Kits, PAUL HARTMANN AG
  45. Safety Notice for Signa MR Excite 1.5T systems, GE Healthcare
  46. Urgent Field Safety Notice for Sample Probe connector for cobas c 311 analyzer, module for…
  47. Recall of the Varico System (hip implants) from Falcon
  48. Information concerning the interface mount by Clinacs with Type 3 accessories from Varian
  49. Corrective action and recall for the Cystic Fibrosis v3 Genotype Assay from Celera…
  50. Recall of the lot number RD-1246 of Human Leptin Elisa from BioVendor
  51. Urgent Safety Notice for the DigitalDiagnost Patient support for stitching, Philips…
  52. Corrective action for the MX 16-slice Computed tomography x-ray system, Philips Healthcare
  53. Urgent Field Safety Notice for Optilite C-Reactive Protein Reagent by The Binding Site…
  54. Safety Notice for the Patient Data Module (PDM) - Mounting Latch Failure, GE Healthcare
  55. Recall Cannon, Cannon II and Edge, Arrow
  56. Urgent Safety Notice for the Patient Data Module (PDM) - Top Cover Heat Buildup, GE…
  57. Urgent Field Safety Notice for SMR Shoulder cementless finned stem L.80mm dia.19m by Lima…
  58. Urgent Field Safety Notice for Prismaflex by Gambro Lundia AB
  59. Tyco Healthcare recalls percutaneous tracheostomy tubes
  60. Guidant recalls Contak Renewal and Contak Renewal 2
  61. Recall for Icelock Expulsion Valve 551, Össur hf.
  62. Safety Notice for the VNS Therapy Demipulse and Demipulse Duo Generators, Cyberonics
  63. Recall of the closesd system apheresis sets, article numbers R2R2210T and R4R2230T, for…
  64. Safety Notice for the Refill Kits Model 8551, Medtronic
  65. Corrective action for Multifibren U on BCS and BCS XP Systems of Dade Behring
  66. Recall for Compostop CS, the C5L, S5L and the C5LT apheresis disposables, Fresenius Kabi
  67. Plus Orthopedics recalls the TC-Plus Solution tibial components
  68. Safety Notice for the Panbio Leptospira IgM ELISA, Standard Diagnostics, Inc.
  69. Recall of the Innova Self-Expanding Stent System, Boston Scientific
  70. Urgent Field Safety Notice for Uni-Gold H. pylori Antigen by Mardx Diagnostics Inc. a…
  71. All EPIQ Systems (models EPIQ Elite, EPIQ 5G, EPIQ 5C, EPIQ 5W, EPIQ 7G, EPIQ 7C, , , EPIQ…
  72. Lot Recall for ProTack fixation device, Covidien
  73. Corrective action for the DOA SALIVA MULTI-6 TEST, DIALAB GmbH
  74. Corrective action for the Lotus™ Valve System, Boston Scientific
  75. Recall tubing sets, hmt Medizintechnik
  76. Safety Notice for the Mueller Hinton 2 Agar, bioMérieux
  77. AGA Medical recalls the AMPLATZER® Duct Occluder
  78. Safety Information for Creatinine Kit Vista 1500® System, Siemens
  79. Safety Notice for Advantage Workstation Suite-Card IQ, GE Healthcare
  80. Batch recall of CPD/SAG-M Quad Optipure & CPD/SAG-M Quad Packpure, Fenwal
  81. Urgent Field Safety Notice for Heater Cooler Unit HCU 40 by Maquet Cardiopulmonary AG
  82. Recall of the lot number 4291A111 of the H.E.L.P.-Heparin Adsorber 500 from B. Braun
  83. Corrective action for the Integra® Licox® Test Sets (BC10R) of the manufacturer GMS…
  84. LUISA (LM150TD)
  85. Information for the pulse oximeter Oxipal OLV-2700K from Nihon Kohden
  86. Corrective action on the MKONA Kit (lot number 01BG) of the Privates Institut für…
  87. Recall of Lifetech IrisFIT Patent Foramen ovale (PFO) occluders, Lifetech Scientific
  88. De Puy International replaces the present version of the Centerline instruments
  89. Merit recalls the Angiography Kit K09-06702B
  90. Lot recall of Proximal Femoral Nail (PFN) ø 10.0 mm cannulated, left, 130°, L 380 mm and…
  91. Malfunction of modulator Reverse diode (D1) for Precise Digital Accelerator, Synergy…
  92. 6673fd83-ddaf-8f19-d82b-d827cd8decfb
  93. Information concerning theStockert EP-Shuttle Generator from Biosense Webster
  94. Recall for BHR Acetabular Cups, Smith & Nephew
  95. ConMed Linvatec recalls the MicroChoice ® Footswitch and ConMed Linvatec 3 Pedal…
  96. Recall of the alternating pressure overlays AS3N and AS3 from Novacare
  97. Recall for NycoCard U-Albumin, Axis-Shield PoC
  98. Safety Notice for CAMERON HEALTH SQ RX Pulse Generator, model number 1010
  99. Recall for SPI Element Dental Implant, SPI Contact Dental Implant, Thommen Medical
  100. Urgent Safety Notice for the HgbPro Professional Hemoglobin Testing System, ITC
  101. Recall for Hintegra saw blade 60° AO-Synthes, Newdeal
  102. Safety Notice for the product Ki67-MM1, Leica Biosystems
  103. Field Safety Notice with Elekta® MLC Software
  104. Safety Notice for the Legendair™ and Supportair™ Ventilators, COVIDIEN
  105. Safety Notice for Innova 2000, GE Healthcare
  106. Information for the UVAR XTS 125 ml centrifuge bowl from Thereakos
  107. Recall of specific vessel cannulae from Maquet
  108. Recall for drill bits, Anspach
  109. Corrective action of Elektro Medical Systems concerning Airflow handy 1
  110. Information concerning the Diagnost 56, Diagnost 66 or Diagnost 76 Systems from Philips
  111. Recall of implantable pulse generators for neurostimulation EON MINI and BRIO, St. Jude…
  112. Recall for DHS Connecting Screws, Synthes GmbH
  113. Urgent Field Safety Notice for TSC PLIF by Orthobion GmbH
  114. Safety Notice for Shark-2334-Footrest, Sunrise Medical
  115. Safety Notice for Spacelabs Medical Vital Signs Monitor élance, Spacelabs Healthcare
  116. Batch recall of FLIPPTACK fixation button, KARL STORZ GmbH & Co. KG
  117. Urgent Field Safety Notice for KWIK-STIK 0947P-K-LYFO-DISK_QC Sets&Panels 5193P by…
  118. Multi Diagnost Eleva flat detector
  119. Kwart Retro-Inject™ Stent Set, Salle Intraoperative Pyeloplasty Stent Set
  120. Safety Notice for EasyVision/RAD, Philips
  121. Warning for Calstrux from Stryker
  122. Corrective action for ADVIA 1200, 1650, 1800 and 2400, Siemens
  123. Urgent Field Safety Notice for NucliSENS Lysis Buffer by bioMérieux SA (Marcy- l'Etoile)
  124. Safety Notice / Corrective action for the Dimension Vista® 500 and Dimension Vista® 1500…
  125. Urgent Safety Notice for Bard® Max-Core® Disposable Core Biopsy Instruments, C. R. Bard…
  126. Urgent Safety Notice concerning the packaging of RT-PLUS™ Femoral Components, Smith &…
  127. Alteration of the Instructions For Use for EndoFit Pre-loaded Thoracic Stent Graft from…
  128. Corrective action for Bilirubin liquid for Cobas Integra and Hitachi analyzers, Roche
  129. Safety Notice for ARCHITECT i1000SR System, Abbott
  130. Advice of leakages during the use of Paclitaxel Infuision Sets from Baxter
  131. Recall for Craniomaxillofacial (CMF) Distraction System, DePuy Synthes GmbH
  132. Urgent Safety Notice for Medtronic Neuromodulation DBS system extensions, Medtronic Inc.
  133. Potential failure with the Image Navigator function of the SIENET COSMOS Workplace from…
  134. Recall and corrective action of Lifescan for OneTouch GlucoTouch blood glucose analyzers
  135. Corrective action for Gemini GXL and Gemini TF, Philips
  136. Problem of undesirable behavior in specific reporting workflow in syngo Dynamics 9.0…
  137. Recall of the Procedure Tray - Knochen set from Mölnlycke Healthcare
  138. Urgent field safety notice for Cleaner A, DiaSys Diagnostic Systems GmbH
  139. Product corrective action for FC 500 flow cytometry systems with CXP software, Beckman…
  140. Lot Recall for the GLUMA Desensitizer Power Gel, Heraeus Kulzer GmbH
  141. Recall of the Arctic Circler® Linear Cardiac Cryoablation Catheter from CryoCath…
  142. Recall for Siluron 1000, Geuder AG
  143. Urgent Safety Information for the Intraaortic Balloon Counterpulsation Catheter, Arrow…
  144. Information for the Aquarius hemofiltration machine from Edwards Lifesciences
  145. Urgent Field Safety Notice for GMK UNI Femur by Medacta International SA
  146. Possibility of front framework breaks with Kimba Spring size 1 and 2 from Otto Bock
  147. Sidam Medical Devices recalls one lot of the Patient extension line
  148. Safety Notice for CODMAN® Medstream® Programmable Infusion Pumps, Johnson & Johnson Codman
  149. Urgent Safety Notice for the Omnis system, Dako Denmark A/S
  150. Urgent field safety notice for intensive care ventilators elisa 600, elisa 800 and elisa…
  151. Safety Notice for HPBLUE (HARMONIC Blue Hand Piece and Blue Test Tip) and HP054 (HARMONIC…
  152. Updated Safety Information for the Synthes Trauma External Fixation System (Small, Medium…
  153. Information concerning the Sirus Intramedullary Nail for Femur System from Zimmer
  154. Urgent Safety Information for the product EXCOR® Blood pump, Berlin Heart GmbH
  155. Urgend field safety notice for VERSANT kPCR Molecular System Sample Preparation, Siemens…
  156. Urgent Field Safety Notice for RiaRSR VGCC Ab by RSR Limited
  157. Software update of the MAGNETOM Sonata system from Siemens
  158. Urgent Field Safety Notice for Easy Life & Easy Life T by Sunrise Medical GmbH & Co. KG
  159. Information about Ortho Clinical Diagnostics Mitis2 System from Ortho
  160. Recall of the V40 Unipolar Hip Heads, Stryker
  161. Information concerning possible dysfunction of the auto start mode for bipolar coagulation…
  162. Safety Notice for MultiDiagnost Eleva with FD, Philips
  163. Important Safety Notice for the HexaPOD evo RT Couchtop Securing Screws, Elekta
  164. Urgent Field Safety Notice for NexGen Legacy Constrained Condylar Knee by Zimmer Inc.
  165. Urgent field safety notice for Molecular Health Guide (MH Guide), Molecular Health GmbH
  166. Urgent Field Safety Notice for FTRD System Set by Ovesco Endoscopy AG
  167. Recall of the "TUA" temporary pacing electrode with stylet from the company Dr Osypka
  168. Urgent Safety Notice for certain models of implantable left ventricular LV CRT bipolar…
  169. Urgent Field Safety Notice for LifePearl microspheres by MicroVention Europe
  170. Software error in the Zeus Anaesthesia System from Dräger
  171. Information for LCS® Metal-Backed Rotating Patella, DePuy
  172. Mislabeling incident with the OptiLock Ports from LeMaitre
  173. Lot recall of SYNCHRON System(s) Rheumatoid Factor (RF) Reagent, Beckman Coulter
  174. eVent Medical recalls the Inspiration Ventilator System
  175. Corrective action for Bivona® Inner Cannula, Smiths Medical
  176. Inion recalls Inion Hexalon Biodegradable ACL/PCL Screw
  177. Corrective action of the BenchMark Automatic Slide Stainers from Ventana Medical Systems
  178. The Mammendorfer Institut recalls the ECG Boy
  179. Information concerning the Hemodialysis System 1000 from Baxter
  180. Safety Notice for Easy Diagnost Eleva DRF X-ray system, Philips Healthcare
  181. Urgent field safety notice for ProteusPLUS, IBA
  182. Corrective action of Dade Behring for N Protein Standard SL
  183. Urgent field safety notice for TECO Intact Proinsulin ELISA Kit, TECOmedical Group
  184. Plus Orthopedics recalls some lots of TC-Plus Solution Inserts
  185. Corrective Action for Vitamin B12-Reagent Kit, Beckman Coulter
  186. Reduction in nebulizing performance of Nebulizer OMRON MicroAir
  187. Corrective action for Calibrator f.a.s. from Roche
  188. Safety Notice for the MITCH TRH System, DePuy
  189. Philips Healthcare: Urgent Safety Notice for the Brilliance CT 16, 64, Big Bore, iCT…
  190. Philips Healthcare: Safety Notice for the CT systems Brilliance CT series (6, 10, 16, 16…
  191. Recall tubing sets, Sorin
  192. Recall for ARCHITECT Total β-hCG Reagent, Abbott
  193. Advice not to use Novabel® any more, Merz
  194. Urgent Safety Notice for the Medrad® Continuum MR Infusion System, Bayer Medical Care
  195. Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
  196. Recall for chirurgical system da Vinci IS2000, Intuitive Surgical
  197. URGENT FIELD SAFETY NOTICE for Alere INRatio®2 PT/INR Test Strips, Heparin Insensitive…
  198. Urgent Field Safety Notice for VERIGENE Reader by Luminex Corporation US
  199. Urgent Safety Notice for the Supera Veritas stent system, IDEV Technologies
  200. Recall of the products Tetrisal S nose drops
  201. Urgent Safety Notice for AVEA® Ventilator All Models, CareFusion Respiratory Systems
  202. Product corrective action for UniCel Dxl 800 Access Immunoassay System Wash Buffer…
  203. Urgent Safety Notice for the SureStep™ One Step Drug Screen Test Device (Urine) Methadone…
  204. Urgent Field Safety Notice for D2RS Systems, Stephanix
  205. Recall for Universal Sling Bar, Liko
  206. Recall for RT-Plus Modular Stepped Drill and RT-Plus Modular Tibial Drill Guide, Smith &…
  207. Urgent Field Safety Notice for HAMILTON-C2, HAMILTON-C3 by Hamilton Medical AG
  208. Safety information for the wheelchairs Sopur P 155 / Quickie F 55 with seat lift from…
  209. Urgent field safety notice for TJF-Q180V Duodenoscope, OLYMPUS
  210. Urgent Field Safety Notice for SMARTSTITCH PP CONNECTOR by ArthroCare Corp.
  211. Recall of the peritoneal dialysis patient connectors PD Night Vario Plus Set, PD Night…
  212. Safety Information for WATCHMAN LAA Closure Technology, Atritech Inc.
  213. Lot specific recall of the NexGen CRA/LCCK/RHK 5 mm Distal Femoral Augment, Size F, Zimmer
  214. Recall of the Synchron Systems Ammonia Reagent from Beckman Coulter
  215. Recall of the Barcode Q-Labels from Abbott
  216. Urgent Field Safety Notice for Ventilator Trolley by Breas Medical AB
  217. Recall and corrective action of Abbott for Architect c8000 analyzers
  218. Recalls of the pre-shaped neurovascular PRAWLER® und PRAWLER® SELECT™ Infusion Catheters…
  219. Urgent Safety Notice / Recall for Snuggle Warm® Sterile Cardiac Warming Blankets, Smiths…
  220. Urgent Field Safety Notice for Minisart by Sartorius Stedim Biotech GmbH
  221. Field Safety Corrective Action for Hamilton-G5/Hamilton-S1 ventilators
  222. Recall for the Trinity Biotech Captia Varicella-Zoster (VZV) IgM from Trinity Biotech
  223. Urgent Field Safety Notice for ZENITH BRANCH ENDOVASCULAR GRAFT-ILIAC BIFURCATION by…
  224. Important Safety Notice for XiO, Elekta CMS Software
  225. Recall for HemosIL von Willebrand Factor Activity, Instrumentation Laboratory
  226. Advise from Gambro Dasco for the dialysis tubing sets with potentially defective transduce…
  227. Corrective action for the Persona Cemented Tibia Drill Bracket, Zimmer
  228. Recall of QuickCat™ Extraction Catheter, Spectranetics
  229. Urgent Safety Notice for the Restoration Modular Cone Body Trials, Stryker
  230. Urgent Safety Notice for Dynamis™ and Gerialit™ Beds, Hill Rom
  231. Urgent Field Safety Notice for Zenith Alpha Abdominal Endovascular Graft, William Cook…
  232. Exchange of adjustment clips in walking aids from Ortopedia
  233. Recall CADD medication cassette reservoirs, Smiths Medical
  234. Exchanges in artificial feet from College Park Industries
  235. Safety Notice for GE Centricity™ Web, Software-Versions 3.0x, GE Healthcare
  236. Recall of Guidant heart pacemakers Insignia and Nexus
  237. URGENT - Field Safety Notice for Philips Model EPIQ 7 Ultrasound System
  238. Recall for the Thorametrix chest drainage system, Biometrix
  239. Urgent Field Safety Notice for Premier Buffer A Reagent, Premier Buffer B Reagent by…
  240. Recall for Biolox forte, Corin
  241. Recall for the IGFBP-3 Elisa Reagent Kit, Beckman Coulter
  242. Recall of the Ranger Standard Flow Disposable Blood/Fluid Warming sets from Arizant…
  243. Lot Recall for ReNu® Multi-Purpose Solution and ReNu® MultiPlus Solution, Bausch + Lomb
  244. Corrective action for the Progressa™ Bed Mattress, Hill-Rom
  245. Recall of the N’Vision Application Cards Model 8870 NNB_01 (InterStim-B software) from…
  246. Urgent Safety Notice for ARIA™, Varian medical systems
  247. Safety Information about a modification of the Reciprocating Saw Attachment V-600SR…
  248. Instructions for Use Recall "Navigation Pin, Ortholock EX Pin and Ortholock", Stryker
  249. Safety Information concerning VSX10030HD Videoscope, VIMS
  250. Urgent Safety Notice for the Synthes SynFix-LR Implant Holder, DePuy Synthes
  251. Urgent Field Safety Notice for FRED easy by Schiller Médical SAS
  252. Information for Evita 2 dura, Evita 4 and Evita XL, Dräger
  253. Recall of HAV Ab-Reagent for use on Access Immunoassay Systems, Beckman Coulter
  254. Safety Notice for Panther Radiation Treatment Planning System, Prowess Inc.
  255. Corrective action for the product DF53C GS CorPatch easy pre-connected with 1.3m cable…
  256. 57c74051-6af0-8bb1-4318-5196e021e5b2
  257. Use of Luer adaptors with Needle-free Connection Systems and Glass Pre-filled Syringes…
  258. PENTAX Video Duodenoscope
  259. Guidant informs about the recall of the Oscor 7 Fr. Introducer Kits
  260. Software problem with the S 5 Heart Lung Machine from Sorin
  261. Recall for TruCore II Biopsy instruments, Medical Device Technologies dba Angiotech
  262. Corrective action for Elecsys b-CrossLaps, Roche
  263. Urgent Field Safety Notice for Artisan by Agilent Technologies Denmark ApS
  264. Baxter: Recall for the Patient Control Module, 2 ml, Single-pack
  265. Information about HeartStart XL M4735 from Philips Medizinsysteme Böblingen
  266. Corrective Action for Stratus CS Acute Care NT- proBNP TestPak reagent, Siemens
  267. Urgent Field Safety Notice for PiCCO Monitoring Kit + ProAQT Sensor by PULSION Medical…
  268. Recall of TracheoFlex and LaryngoFlex Sets, Willy Rüsch AG
  269. Safety Notice for the ADVIA Centaur products: Fluorescein Interference with ADVIA Centaur…
  270. Correction Notice for VITEK® 2 Antimicrobial Susceptibility Test Kits (AST), bioMérieux…
  271. Urgent Field Safety Notice for BD OneFlow B-CLPD T1 by Becton, Dickinson and Company, BD…
  272. Recall for BD Saline XS 3 ml, Becton Dickinson
  273. Lot Recall for the Comprehensive Primary & Fracture Shoulder Stem Inserter, Biomet…
  274. Corrective action for Biolox Delta Ceramic Head 36mm Standard, Biomet UK Ltd.
  275. Safety Notice for Alaris Gateway Workstation, CareFusion
  276. Recall of ANA.NOVA® MII neck, Intraplant GmbH
  277. Corrective action for IMMULITE® 2000/IMMULITE® 2000 XPi, VersaCell or VersaCell X3 system…
  278. Corrective action for MYLA V3, bioMérieux
  279. Recall for Platinum Plus, Boston Scientific
  280. Important Information: Error in the IFU of a peritoneal dialysis tube set, Baxter
  281. Urgent Field Safety Notice for Mediplus by Mediplus Ltd.
  282. Safety Notice for the MS2 mobile stand, Moor Instruments
  283. Recall for WATCHMAN® LAA Closure Delivery System, Atritech Inc.
  284. Safety Notice for Centricity PACS RA1000 Workstation; Software: 2.1.x and 3.0.x, GE…
  285. Lot Recall of the DePuy Attune™ Impaction Handle, DePuy
  286. Urgent Field Safety Notice for DOTCH Puru Syringe by STAXS The Netherlands BV
  287. Recall of the Transend™ EX.014/205 Soft Tip Guidewire from Boston Scientific
  288. Corrective Action for Dimension Vista Total Prostate Specific Antigen Flex reagent…
  289. Urgent Field Safety Notice for FTD FLU/HRSV by Fast-Track Diagnostics S.a.r.l.
  290. Urgent Field Safety Notice for BVI CustomEyes Kits and Malosa Kits by Beaver Visitec…
  291. Urgent Field Safety Notice for Experience Mini Metal Rhodium by GC Orthodontics Europe…
  292. Recall of the Vidaurri LASIK Flap Irrigators from Oasis Medical
  293. Recall of Bacillol AF 500 ml and Bacillol plus 500 ml from Bode Chemie
  294. Recall for Impella® 5.0, ABIOMED
  295. Safety Notice for Flexitron HDR Afterloader, Nucletron
  296. Terumo recalls the Sarns Flexible Arterial Cannula 7,5 mm
  297. Information for Jostra HL30, Maquet
  298. Safety Notice for Paraffine Heater PT15, Heuser Apparatebau
  299. Recall for MAS Cardiolmmune XL Liquid Assayed Cardiac Marker Control, Siemens
  300. Urgent Safety Notice for the RaySearch RayStation 4.0, RaySearch Laboratories
  301. Corrective action for the Dimension Vista® Phenytoin Flex® reagent cartridge, Siemens…
  302. Lot Recall for PRISMAFLEX ST and PRISMA ST Sets, Gambro
  303. Lot recall of Destination™ Carotid Guiding Sheaths, Terumo
  304. Corrective Action for AMPLILINK software v. 3.2, Roche
  305. Recall of Dade Behring for Dade Actin FS
  306. Recall for FC 500 with CXP 2.2 Acquisition Software and FC500 MPL with MXP 2.1 Acquisition…
  307. Recall for Linton-Nachlas catheter, Coloplast A/S
  308. Lot recall of NeuroBalloon™ Catheter, Integra NeuroSciences Implants SA
  309. Safety information and corrective actions for Applix Smart and Applix Vision Nutrition…
  310. Urgent Field Safety Notice for TFNA Femoral Nail, VA-LCP Clavicle Plate, OPAL…
  311. Medline Surgical Clipper Charger base with EU plug - tagasikutsumine vigase komponendi…
  312. Recall of Brahms for PAPP-A Kryptor
  313. Safety Notice for the ACUSON SC2000™ ultrasound system, Siemens Medical Solutions USA…
  314. Urgent Safety Notice for the product D-Dimer Gen.2, Roche Diagnostics
  315. Urgent Field Safety Notice for Compact 5 by DeVilbiss Healthcare Ltd.
  316. Recall for the Vagiflor® vaginal suppository 6 and 12 pieces, Chiesi GmbH
  317. Danger of injury when using the sandblasting device Rocatector from 3M ESPE
  318. Another Safety Information for the ACUSON SC2000™ ultrasound systems, Siemens Medical…
  319. Urgent Field Safety Notice for ACCULAN 4 OSCILLATING SAW STRAIGHT by Aesculap AG
  320. Safety Notice for Allura Xper and Integris, Philips
  321. Urgent Field Safety Notice for Blasendauerkatheder by Asid Bonz GmbH
  322. Recall of the products BD Visc Viscoelastic Solution from Becton Dickinson
  323. Recall of secondary sets containing back check valve, CareFusion
  324. Boston Scientific recalls Enteryx Procedure Kits and Enteryx Injector products
  325. Corrective action for HemoCue Glucose 201 Microcuvettes, HemoCue
  326. Corrective Action for Antimicrobial Susceptibility Testing Disc CN30 GENTAMICIN, Oxoid
  327. Urgent Field Safety Notice for Multiple Medical Devices of Hemodialysis catheter and…
  328. Information for Allura Xper FD10 and FD10/10, Philips
  329. Information concerning the Gambro Prismaflex Systems from Gambro
  330. Corrective action for COULTER GEN-S and LH SlideMakers, Beckman Coulter
  331. IFU Update for the PARACHUTE Delivery System, CardioKinetix
  332. Advisory Notice from Medtronic for Valiant Thoracic Stent Graft
  333. Information for Fabius Tiro, Dräger
  334. Software update of Spektrum and Passport 2 monitors from Datascope
  335. Recall for carpal button screws, Small Bone Innovation International
  336. Safety Notice for the Philips Model EPIQ 7 Ultrasound System, Philips Healthcare
  337. Possible misassembled plugs in chargers for Echo-Screen / AccuScreen, Natus Europe
  338. Urgent Safety Notice for the Philips HeartStart XL+ Defibrillator/Monitor, Philips…
  339. Safety Notice for FRED easy, Schiller
  340. Recall of Abbott for CELL-DYN diluent
  341. Recall of software version 3.2 for the s5/s5i™ imaging system, VOLCANO
  342. Urgent Field Safety Notice for Tubing Set TPE LIFE 18 - TPE Line by Miltenyi Biotec GmbH…
  343. Possibility of mismatching VAC and AIR sockets of Dräger AIR Dual PLUG Connector
  344. Recall of ReNu Multi-Purpose Solution, Bausch & Lomb
  345. Urgent Safety Notice for the Philips HeartStart XL+ Defibrillator/Monitor, Philips…
  346. Urgent Safety Information for the EnduRo Knee-System, Aesculap
  347. Exchange of the Gold Hub Capistrano-, Gold Hub Finesse- and Gold Hub Monty Cannula from HK…
  348. Information about peripheral monitors from Edwards Lifesciences
  349. Recall for Restoration Modular Components, Stryker
  350. Recall and corrective action of BioMerieux for Vitek 2 GN ID Test Kits
  351. Corrective action for the toilet raiser fixed Hi-Loo and toilet armrest Supporter, Etac…
  352. Recall for LiNA Grey Shark and White Shark, LiNA Medical
  353. Corrective action for APTIMA Urine Collection Kit, Hologic Deutschland GmbH / Gen-Probe…
  354. Recall of the Seradyn Innofluor Gentamicin Calibrator with lot number 501976
  355. Anomaly in VARiS Vision`s Treatment 6.6 application from Varian
  356. Information concerning the recall of laser devices EndoSet and EndoFiber of the company…
  357. Urgent field safety notice for SagiNova Control Software, Eckert & Ziegler BEBIG GmbH
  358. Urgent Field Safety Notice for iAssist Validation Tool/SmartTools Knee System by Zimmer…
  359. Corrective action of Roche for Gluc/(Lac/Urea) cassettes
  360. Recall of Suction Tubings from Single Use Surgical
  361. Recall for the Architect C-Peptide Reagent, Abbott
  362. Safety Notice for the 4D Integrated Treatment Console Version 8.1.3 to 8.8, Varian medical…
  363. Safety Information/Update for the Cranial Navigation System (all versions), Brainlab
  364. Lot recall of UrgoClean Ag 10x12 OP (20 pieces), URGO GmbH
  365. Corrective action of BioMerieux for VeriCal
  366. Corrective action for the Dameca MRI 508, Philips Healthcare
  367. Urgent Field Safety Notice for MRP- Schraube M6 by PETER BREHM GmbH
  368. Information for VIDAS CEA (S) Kits, Biomerieux
  369. Corrective action for the IntelliVue Patient Monitors MP2, X2, MP5/MP5T and MP20-50…
  370. Urgent Field Safety Notice for IH-1000 Analyzer by Bio-Rad Laboratories, DiaMed GmbH
  371. Anomaly in VARiS Vision RTP Exchange from Varian
  372. Software issue regarding iBGStar® blood glucose meter, AgaMatrix Inc.
  373. Recall of the connection component rotational version of the Endo-Model SL Rotational and…
  374. Urgent Safety Notice concerning Filter for dialysate purification EF-02D, Nikkiso
  375. Bridge Occlusion Balloon
  376. Urgent Field Safety Notice for HP xxx D/x/x mit Hercotherm Ring by Herco Wassertechnik…
  377. Safety Notice for the pressure regulator G40600 used in the main gas pipe RE 1200 Basic…
  378. Urgent Safety Information concerning ETHICON Morcellation Devices, Ethicon, Inc.
  379. Recall for wheelchair Action³, Invacare Aquatec GmbH
  380. Urgent Safety Notice for the HbA1c Calibrators, Abbott Laboratories
  381. Single incident during the use of a flexible implant tube with blind end from Varian
  382. Recall of TRIGEN KNEE NAIL from the company Smith & Nephew
  383. Safety Notice for MOSAIQ and Multi-ACCESS, IMPAC
  384. Safety Notice for AEDs HeartStart HS1, Philips
  385. Recall for Fogarty Fortis Catheters, Edwards
  386. Recall for SpineJack Preparation Kit, Vexim SAS
  387. Recall and corrective action of Beckman Coulter for Synchron LX systems
  388. Safety Notice for LightCycler®-capillaries, Roche
  389. Recall of Compactor, Type 8868,001, Batch P803768, Richard Wolf GmbH
  390. Corrective action for Xevo TQ MS, Waters
  391. Urgent Field Safety Notice for INNEX TIB INSERT FIXUC L112.5 and Modular Bipolar by Zimmer…
  392. Recall for PE-Inlays, OHST
  393. Urgent field safety notice for AQURE with FLEXLINK, Radiometer
  394. UNISEPTA FOAM 2 WIPES
  395. Safety Notice for Gemini TF 64 slice - Brilliance 64 CT scanners subcomponent, Philips
  396. Recall for Sterimedix/Altomed Ophthalmic Irrigation/Aspiration Coaxial Handpieces/Bimanual…
  397. Urgent Field Safety Notice for LifeSeal by LifeBond
  398. Safety Notice for SynchroMed II Implantable Drug Infusion Pump - Model 8637, Medtronic
  399. Urgent Field Safety Notice for PROGRESSA BED SYSTEM by Hill-Rom Company, Inc.
  400. Recall for Portex Blue Line Ultra Tracheostomy Kit, Smiths Medical
  401. Important Notice regarding Stratus OCT™ Instrument and Review Software 6.0.0., Carl Zeiss…
  402. Safety Notice for the dynamic multileaf collimator (DMLC), Elekta
  403. Safety Notice for Skippi power wheelchair for children, Otto Bock
  404. Safety Information about handling problems with both adapters for the extension device…
  405. Corrective action for Elecsys Folate II on Elecsys 2010 systems from Roche
  406. Safety Notice on how to properly configure and limit the collimator jaw settings in…
  407. Extended Recall of Ureter Catheter, Teleflex
  408. Aesculap recommends to check the tibia preparation plateaus
  409. Information about the potential risk and effects of overcharging the internal batteries…
  410. Safety Notice for Freedom Solo Heart Valves, Sorin Biomedica
  411. Safety Notice for Carescape Monitor B850, GE Healthcare
  412. Lot recall of SYNCHRON System(s) Immunglobulin A (Ig-A) Reagent, Beckman Coulter
  413. Urgent Field Safety Notice for AIM Tibial Nail by Biomet Orthopaedic LLC
  414. Information for Secura DR ICD/ Consulta CRT- D, Medtronic
  415. Recall for the MGuard Prime Coronary Stent System Embolic Protective Stent (EPS)…
  416. Information concerning the Level 1 H-1200 and Level 1 H-31B Air Detector acessory from…
  417. Recall for NexGen Complete Knee Solution MIS Total Knee Procedure Tibial Broach Impactor…
  418. Recall for XP Laryngoscope Blade Mac 3, Heine
  419. Lot Recall for P.F.C. Sigma Modular Tibial Tray, DePuy
  420. Urgent Safety Notice for the Flexi-Seal™ CONTROL™ Fecal Management System, ConvaTec
  421. Lot Recall for COBE Spectra apheresis collection system WBC Tubing Sets, CaridianBCT
  422. Recall of several reference and lot numbers of the Coronary Ostia Cannula, Terumo
  423. Recall for PTS Panels CHOL+HDL+GLU, Polymer Technology Systems
  424. Recall for Minutex D-Dimer, Tcoag
  425. Recall for Whole Blood Controls RQCHRT for Use with Hemochron Kaolin and Celite HRT Test…
  426. Lot Recall for PSD Gel packed with different Peri-Strips devices, Synovis Surgical…
  427. Safety Information concerning LIAISON® VZV IgG and LIAISON® VZV IgM, DiaSorin S.p.A
  428. Recall for Covidien Devon™ Light Gloves and certain sub-assembly kits that include the…
  429. Recall for the GIS-10 OxyBloc Bite Block Device, Diagmed Healthcare Ltd.
  430. Safety Information for REMstar M Series Humidifier, Philips Respironics
  431. Transient suspension for the product for sales and marketing from Tropon
  432. Recall of the SealGuard™ Tracheosoft™ and SealGuard™ Tracheosoft™ PERC™ tracheostomy…
  433. Corrective action for Avantx-E, Innova 2000, 2100IQ, 3100/3100IQ, 4100/4100IQ and…
  434. Corrective action for the Vivid E9 ultrasound systems and probes C1-5-D, C2-9-D, IC5-9-D…
  435. URGENT - Medical Device Correction MDC PACS R2.x / IntelliSpace PACS R3.x, Phillips
  436. Corin Medical recalls the Uniglide Femoral Drills
  437. Urgent Field Safety Notice for Belonging to 132-150/03 by Waldemar Link GmbH & Co. KG
  438. Corrective action for the BD™ BBL™ Staphyloslide Latex Test from Becton Dickinson
  439. Safety Notice concerning a corrective action of the infant incubator V-2200, Atom Medical
  440. Urgent Field Safety Notice for Stage-1 Tissue Punch, Disposable, 4.5mm by Keystone Dental…
  441. Urgent Field Safety Notice for ARIES products by Luminex Corporation
  442. Acuity Universal Cutter
  443. Urgent Field Safety Notice for Mindframe Capture LP by MindFrame Inc.
  444. Urgent field safety notice for BD Retic-Count (IVD), Becton Dickinson S.A.S
  445. Safety Notice for Carescape Monitor B850, GE Healthcare
  446. Urgent Field Safety Notice for Servo-i, Servo-s, Servo-u, Servo-n, Servo-air by Maquet…
  447. Urgent Field Safety Notice for Molift 2-poing Sling Bar - all sizes by Etac Supply Gjøvik
  448. Advanced Sterilization Products (ASP) recalls the vaporizer plates
  449. Recall for Ultraflex Esophageal™ NG Stent System; Ultraflex™ Tracheobronchial Stent System…
  450. Information about the correct insertion of the disposable wash set bowl of the Compact…
  451. Safety Notice for Incubator 8000 Familie, Babytherm 8000 OC, RH 600, PP 800, PP 8000 and…
  452. Urgent Field Safety Notice for Access 2 System, UniCel DxC 600i Syncron System by Beckman…
  453. Corrective action for the HeartWare® Ventricular Assist System, HeartWare, Inc.
  454. Urgent Field Safety Notice for Protura Robotic Patient Positioning Software, CIVCO Medical…
  455. Software problem with Active Breathing Coordinator from Elekta
  456. Recall for Ventralight™ ST Mesh with Echo PS™ Positioning System and Composix™ L/P Mesh…
  457. Lot Recall for Biatain Ag adhesive foam dressing, Coloplast
  458. Recall for GEM Premier 3500, Instrumentation Laboratory
  459. Recall of ABC Screwdriver F/Selflocking Screws, Art. No. FJ910R with UNICOS cording C100A…
  460. Follow-up Information for the Terumo® Advanced Perfusion System 1 - Heart-Lung Machine…
  461. Urgent Safety Notice concerning GE Warmers with Nellcor SpO2, GE Healthcare
  462. Information about a temperature increase of the transducer surface from Toshiba Medical…
  463. Safety Notice for WM-P1, WM-260 and WM-SC ranges of mobile workstation trolleys, Olympus…
  464. Corrective Action for the UniCel DxH 800 Coulter Cellular Analysis System, Beckman Coulter
  465. Corrective action for Clinical Chemistry Total Bilirubin, Abbott
  466. Recall for 560P High Definition Camera Control Unit, Smith & Nephew
  467. Corrective action of Becton Dickinson for FACSCanto Flow cytometer
  468. Safety Notice for GALILEOS 3D, Sirona
  469. Cytomics FC 500 MPL, Model/Catalog 626554
  470. Comfort Shield Barrier Cream Cloths. Priority 2 – Warning
  471. Recall of power supplies for Akita Jet and Akita II Apixneb inhalation devices, Activaero…
  472. Urgent Field Safety Notice for 17G Wallace Single#Lumen Oocyte Recovery Set by…
  473. Urgent Field Safety Notice for PadPro Mini-Infant Multifunction Electrodes -2602 by ConMed…
  474. DPC Biermann recalls Immulite 2500 Homocysteine kits
  475. Lot recall of manometer tray / Jamshidi Needle Biopsy / Illinois (TJ) needle aspiration /…
  476. Recall of the intraocular lens model EC-3 from Ophthalmic Innovations International
  477. Information for m2000sp Instrument, Abbott
  478. Recall for Access Thyroglobulin Antibody II, Beckman Coulter
  479. Lot Recall for the S.M.A.R.T. ® Nitinol Stent System and S.M.A.R.T. ® CONTROL ® Nitinol…
  480. Safety Notice for Axis and Irix Gamma Cameras, Philips
  481. Product safety advisory of the Signal Acquisition Module model 8300
  482. Recall of the Superflex ring strippers of the first generation from Fehling Instruments
  483. Safety Notice for Tonometer Measuring Prism, HAAG-STREIT AG
  484. Recall of Hospal Cartridge C3 from Gambro Dasco
  485. Recall for Ascendra Balloon Catheter, Edwards
  486. Safety Notice for Discovery VCT, RX VCT, STE, RX and ST PET/CT systems with Dimension…

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