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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 Safety Notice for the Biosense Webster’s SMARTABLATE™ Generator System manufactured…
  2. Safety Notice for the neoBLUE® blanket LED Phototherapy System, Natus Medical Incorporated
  3. Software-Update on the Telemetry Systems WEP-4200 from Nihon Kohden
  4. Safety Notice for the Ingenuity Core128 system with software version 3.5.5, Philips…
  5. Urgent Field Safety Notice for BD MAX Enteric Bacterial Panel by GeneOhm Sciences Canada…
  6. Recall Trigen HFN Nail, Smith & Nephew
  7. Safety Notice for all MX-16 slice CT scanners, Philips
  8. Corrective action for ADVIA 120 / 2120 Systems, Siemens
  9. Safety Notice for NIOX® und NIOX® Flex, Aerocrine
  10. Corrective Action for HeartStart MRx, Philips
  11. Safety Notice for the AQT90 FLEX Analyzer, Radiometer
  12. Recall FlexCath®, CryoCath
  13. Urgent Field Safety Notice for 3M Surgical Clipper Professional by 3M Health Care
  14. Safety Notice for NexGen Complete Knee Solution MIS Tibial Component, Zimmer Inc.
  15. LEXXOO International recalls LEXX Tageslinsen
  16. Recall of Nephrostomy Sets, Urotech GmbH
  17. Safety Notice for Cire de Horsley (Bone wax stick), B. Braun Surgical S.A.
  18. Safety Notice for the Siemens Linear Accelerator, Siemens Healthcare
  19. Safety Notice for BD Venflon 22GA Peripheral IV Catheters, BD
  20. Urgent Field Safety Notice for Free ßhCG KRYPTOR, B-R-A-H-M-S GmbH / ThermoFisher…
  21. Information about the importance of regular AU Clinical Chemistry Analyser maintenance…
  22. Recall for Valve Types OF-B136, OF-B140, OF-B163 and OF-B179, Pentax
  23. Recall of batches of preparation balls with x-ray thread respectively of the procedure kit…
  24. Safety Notice for the NobelReplace and Replace Select Tapered Implant System, Nobel…
  25. Urgent field safety notice for ProGrade, Philips Medizin Systeme
  26. Safety Notice for Carescape Monitor B850, GE Healthcare
  27. Recall for TriniCLOT aPTT HS, Trinity Biotech
  28. Safety Notice for iCentral and iCentral Clients v5.0.2, GE Healthcare Finland Oy
  29. Recall LeVeen SuperSlim Needle Electrodes, Boston Scientific
  30. Urgent Safety Notice for the BIRMINGHAM HIP™ Modular Head, Smith & Nephew Orthopaedics
  31. Batch recall of custom procedure packs containing Medtronic / Covidien Devon Light Gloves…
  32. Safety Notice for Diagnost 56/66/76, EasyDiagnost and EasyDiagnost Digital with SCP…
  33. Lot recall of 12 Fr SLS II Laser sheaths, Spectranetics Corporation
  34. Corrective action for FB, ZYM B, API Listeria and API NH, bioMérieux
  35. Recall of RSP monoblock / Turon impaction block fixtures, DJO Surgical / MDSS GmbH
  36. Urgent Field Safety Notice for VYLIFE, KIT VYLIFE by VYGON S.A.
  37. Guidant recalls the implantable pacemaker models Pulsar, Pulsar Max, Pusar Max II…
  38. Safety Notice for LithoDiagnost and UroDiagnost, Philips
  39. Unintentional movements concerning the C-arm of Integris Allura Biplan X-ray Imaging…
  40. Recall of the Microcuff® Magill endotracheal tube from Kimberly-Clark Health Care
  41. Corrective action for the IMMULITE® 2000/IMMULITE® 2000 XPi Immunoassay Systems, Siemens…
  42. Information about the recall of the Eva450EE mobile hoist, serial no 373317696102195…
  43. Alere Triage TOX Drug Screen
  44. Disetronic recalls the adapters for insulin pumps D-TRONplus
  45. Potential of overinfusion with the 6060™ Multi-Therapy Infusion Pump, Baxter
  46. Safety Notice for Seraclone Anti-k (KEL2), Bio-Rad
  47. Urgent Field Safety Notice for Cobas b221 by Roche Diagnostics GmbH
  48. Information for the hand-driven bike model Shark from Sunrise Medical
  49. Safety Notice for Patient Monitor, Model 91387, Spacelabs Healthcare Inc.
  50. Urgent Field Safety Notice for ARTISTE MV Systems; ONCOR; PRIMUS; MEVATRON by Siemens…
  51. Oxoid Legionella BCYE Growth Supplement, SR0110A
  52. Safety Notice for FL400 Fluorescence Imaging Feature for M720 OH5, Leica
  53. Corrective action of the FC 500 with CXP Software (versions 2.1 and 2.2) and CXP Analysis…
  54. Safety Notice for Philips IntelliVue Clinical Information Portfolio, Philips Healthcare
  55. Urgent Field Safety Notice for CLINITEK Status+ Analyzer and CLINITEK Status Connect…
  56. Corrective action of all lot numbers of the product Streptatest from milenia biotec
  57. Recall Advantage® heart valve prosthesis, Medtronic
  58. Information for dialysis tubing systems, Gambro Dasco
  59. Exchange of motors in dentist’s chair model Estetica E70 and E80, Kaltenbach & Voigt GmbH
  60. Safety Notice concerning the TIRF/ DirectFRAP slider, Carl Zeiss
  61. Ciba Vision recalls the contact lens care product Clerz
  62. Recall of the Infant Nasal CPAP Cannulas/Systems from Teleflex Medical, Hudson RCI
  63. Recall for Cleanisept Wipes, Dr. Schumacher
  64. Recall of Turbiquant N Rheumatology Standard SL, N/T Rheumatology Control SL/1 and N/T…
  65. Corrective Action for Galileo Echo due to defective temperature sensor, Immucor
  66. Urgent Safety Notice for the Probe Tubes, Siemens Hearing Instruments Ltd./Sivantos GmbH
  67. Revised Instruction for Use of the MARS Monitor from Gambro
  68. Recall PlusSpeed® coaxial needles, Peter Pflugbeil
  69. Recall for Neuroform 3 Microdelivery Stent System, Boston Scientific
  70. Philips MR systems
  71. Urgent field safety notice for Pressure Regulator, Omrix / Ethicon Inc. / Johnson &…
  72. Recall of the CoStar® Paclitaxel-Eluting Coronary Stent Systems from CONOR Medsystems
  73. Recall of Corail Revision Hip broaches, DePuy
  74. Corrective action of Siemens for TIBC Reagent, Siemens
  75. Corrective action for the da Vinci® Xi™ Surgical System, Intuitive Surgical, Inc.
  76. Recall of Fenestrated Screw Open Alignment Guide, DePuy Spine
  77. Urgent Field Safety Notice for Artis Q, Artis Q.zen by Siemens AG / Healthcare Sector /…
  78. Urgent Field Safety Notice for Zirkon Primer by GDF Gesellschaft für Dentale Forschung und…
  79. Information concerning the Codman Hakim valve programmers from Ethicon
  80. Lot recall for Covidien Emprint Percutaneous Antenna with Thermosphere Technology…
  81. Urgent Field Safety Notice for IMTEC-SmD1-A by HUMAN Gesellschaft für Biochemica und…
  82. Recall of SynchroMed II Implantable Infusion Pump Models 8637-20 and 8637-40, Medtronic
  83. Recall of the cap of the powder chamber of AIR-FLOW® handy from EMS ELEKTRO MEDICAL
  84. Lot recall of SERANOX sternum wire SKU# WO80126B, Serag-Wiessner GmbH & Co. KG
  85. Recall of Femoral Clamps TKR (slim) by Plus Orthopedics
  86. Recall of Shoulder Forked Retractor, Zimmer Biomet
  87. Lot recall of GyneFix, Gynlameda GmbH
  88. Corrective action for the cobas® 8000 modular analyzer / cobas e 602 module, Roche…
  89. Lot recall of BioMatrix Flex and BioMatrix NeoFlex Drug Eluting Coronary Stent System…
  90. Information for the textile stretcher Werolife 210090 from Wero
  91. Information concerning the Provox 2 voice prosthesis from ATOS
  92. Urgent Field Safety Notice for BOND-PRIME by Leica Biosystems Melbourne Pty Ltd
  93. Urgent Field Safety Notice for intrauterine pessaries Ancora, Novaplus and Gold-T by…
  94. Lot Recall for LRS ADV, Micrometric Translation-Angulation Clamp, Orthofix
  95. Recall FlexCath®, CryoCath
  96. Recall for Aimer Endofemoral, Smith & Nephew
  97. Urgent Safety Notice for the Expression Information Portal (IP5), Philips Healthcare
  98. Recall for Flexima Biliary Stent Systems, Boston Scientific
  99. Safety Notice for WaveLight® FS 200 Femtosecond Laser, Wave Light GmbH
  100. Recall for the Anatomical Shoulder Handle for Rasp, Zimmer
  101. Urgent Field Safety Notice for VITEK MS instrument by BioMérieux SA
  102. Corrective action and recall from Radiometer Medical for ABL700/800 analyzers
  103. Recall/Corrective Action for Modular glucose method (GLUCm) on SYNCHRON LX and UNICel DxC…
  104. Urgent Safety Notice for the Morcellator Handpiece for Morce Power Plus, Richard Wolf GmbH
  105. Urgent Field Safety Notice for EliA Sample Diluent, ImmunoCAP Specific IgA/IgG Sample…
  106. Information concerning an reinforcement of the backrests of the wheelchair model Spin-X…
  107. Urgent Field Safety Notice for STERILCONTAINERSYSTEM BASIS / AICON by Aesculap AG
  108. Corrective action and recall of the Architect System (software versions 2.12, 2.20…
  109. Recall for IMx Sirolimus Reagent, Abbott
  110. Urgent Field Safety Notice for Protective Cover of Vivo 55/65 by Breas Medical AB
  111. Information for the INSIGNIA and NEXUS pacemakers from Guidant
  112. Corrective action and recall of the Architect System (software versions 2.10, 2.11, 2.12…
  113. Safety-relevant recommendation for Applix Smart / Applix Vision, Fresenius Kabi
  114. Guidant recalls Omnilink Peripheral Stent Systems
  115. Additional cleaning and disinfection of Hydrotherapy devices from BEKA
  116. Safety Notice concerning a problem with type III wedge assemblies on all Varian Clinacs®…
  117. Urgent Safety Notice on implantable cardioverter defibrillators Convert+ V-195, St. Jude…
  118. Safety Notice for Orthoss® Collagen, Geistlich Pharma AG
  119. Safety Information for Diapac Ultra DF-Online Filter, B. Braun
  120. Information for AutoMate Sample Processing Systems, Beckman Coulter
  121. Recall BioArchive Vapor Bypass Assembly, Thermogenesis
  122. Information that there is a non conformity of the products TriniCAL, TriniCHECK Control…
  123. NavLock Tracker (part of NavLock instrument sets)
  124. Urgent Field Safety Notice for Dimension Vista High Density Lipoprotein Cholesterol Flex…
  125. Corrective action for Dimension Vista Systems Cyclosporine (CSA) Flex reagent cartridge…
  126. Safety Notice / Validated sterilization instructions for the product Reusable Temperature…
  127. Urgent Field Safety Notice for BRF/URF for cobas 8100 by Hitachi High-Technologies…
  128. Recall for TruCal ApoA1 calibrator set, Diasys
  129. Recall of of MX9636 - MEDEX PDS Kids Kit from Smiths Medical International Ltd
  130. Recall of two lots of the Ascendra2 Transapical Delivery System, Lifesciences LLC
  131. Safety Notice for Consulta CRT-D, Secura DR/VR, Concerto II CRT-D, Virtuoso II DR/VR…
  132. Miehtke recalls severeal lots of their control reservoir
  133. RA-75811 0180/OMNERA 400T (2021-05-17)
  134. Recall for Mediselect II and Medireg II, GCE, s.r.o.
  135. Recall of ball electrode, inomed Medizintechnik GmbH
  136. Field Safety Notice of the compressor nebulizers MicroElite Standard and MicroElite Deluxe
  137. Safety Notice for the Cadisc™ Distractors, Ranier Technology Limited
  138. Urgent field safety notice for Artis systems with wireless foot switch, Siemens Healthcare…
  139. Information concerning the HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis…
  140. Safety Notice for Portable Bedside Capnograph/ Pulse Oximeter N85-1, Nellcor
  141. Incorrect SUV values (Standardized Uptake Value) displayed in Brilliance Workspace Portal…
  142. Recall of several lots of Swan Ganz Continuous Cardiac Output catheters, Edwards…
  143. Lot recall of cortex screw Ø 3.5 mm / self-tapping / stainless steel / sterile, DePuy…
  144. Recall of Microtrol Campylobacter jejuni from Becton Dickinson
  145. Lot Recall of Tibial Broaches, DJO Surgical
  146. Safety Notice for Aespire, Avance, Amingo and ADS180 Anaesthesia Machines, GE Healthcare
  147. Lot recall of various polyethylene implants, Zimmer Biomet
  148. Urgent Field Safety Notice for Barrx 360 Express RFA Balloon Catheter by Covidien llc
  149. Recall of Vidas CA 15-3 from BioMerieux
  150. Information for STERRAD® Systems, Advanced Sterilization Products
  151. Lot Recall for the RSP Humeral Socket Shells, DJO Surgical
  152. Urgent Field Safety Notice for VITEK 2 AST-N371 by bioMérieux Inc
  153. Recall of the Cool-tip™ Ablation System from the company Tyco Healthcare Ltd.
  154. Infomrmation for Fast Plan, Varian
  155. Lot Recall for Osseotite, BIOMET 3i
  156. Safety Information for the device HPA BeadChip Kit, Immucor Medizinische Diagnostik
  157. Urgent Safety Notice for the Trellis™ 8 Peripheral Infusion Systems, Covidien LLC
  158. Software upgrade of the LOGIQ 3 Expert ultrasound scanner from GE Healthcare
  159. Safety Notice for EVO Clinical 100-Analyser, Tecan
  160. Nihon Kohden replaces interfaces for bedside monitors
  161. Corrective action for System Reagents, Olympus
  162. Lot Recall for Clip Piston MVP, HEINZ KURZ MEDIZINTECHNIK
  163. Information from Smith for the use of Fast Flow Fluid Warmers (Series H-1025)
  164. Safety Notice for the Moore Medical Alcohol Prep Pads copackaged in Grael PSG Starter Kit…
  165. Safety Notice for the LimiFlex Paraspinous Tension Band, SIMPIRICA SPINE
  166. Recall RiwoMobile, Richard Wolf GmbH
  167. Urgent Field Safety Notice for Infinity Acute Care System (IACS) by Draeger Medical…
  168. Recall of Complete Moisture Plus from AMO Advanced Medical Optics
  169. Urgent Field Safety Notice for Eluxeo 700 Series by FUJIFILM Corporation
  170. Recall of the m2000 barcode readers from Abbott
  171. Safety Notice concerning a corrective action of the Dräger monitor holders of the…
  172. Corrective Action for Access HAV Ab Kit for use on Access Immunoassay Systems, Beckman…
  173. Lot Recall for CollaGuide, KENSAY NASH
  174. Corrective action for Artis Q/Q.zen systems, Siemens Healthcare
  175. Urgent field safety notice for digital linear accelerators ARTISTE / ONCOR / PRIMUS…
  176. Urgent field safety notice for Elecsys Estradiol II, Roche Diagnostics
  177. Urgent field safety notice for Instinct Java System Instruments, all lot numbers /…
  178. Safety Notice for thermosept alka clean forte and thermosept NKZ, Schülke
  179. Corrective action for the Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT…
  180. Urgent Safety Notice for the Tyvek® Self-Seal Pouches with STERRAD® Chemical Indicator…
  181. Batch recall of ECHOLON 60 ENDOPATH STAPLER Endoscopic Linear Cutter (Straight; EC60…
  182. Recall for PSA Rapid Test, möLab
  183. Field Safety Notice of Magnetic Resonance Tomography systems 1.5T Intera and 1.5T Achieva
  184. Recall of AltaFlow Measuring Catheters, OptiMed
  185. Urgent Field Safety Notice for Alaris VP with Guardrails by CareFusion Switzerland 317…
  186. Recall for Dimension Vista B2-Microglobulin Flex reagent cartridge, Siemens
  187. Zimmer recalls one lot of an implantation instrument for hip endoprothesis
  188. Recall for Dimension Vista Cystatin C Flex reagent cartridge, Siemens
  189. Recall for CELL-DYN Emerald Cleaner, Abbott
  190. Recall of several batches of the products Luk-O-sept AF lemon and Luk-O-sept AF neutral…
  191. Safety Notice concerning a problem with SR Viewer Reporting Tool, GE Healthcare
  192. Field Safety Notice of the Amplatzer® Cardiac Plug
  193. Recall for Biogel® surgical gloves with Eclipse Reveal System, Mölnlycke Health Care
  194. Recall NexGen®, Zimmer
  195. Urgent Field Safety Notice for cobas 8000 by Hitachi High-Technologies Corporation
  196. Worldwide Recall of the MitraClip System, Abbott Vascular, Evalve Inc.
  197. Recall Urgent Safety Information for COLLEAGUE infusion pumps from Baxter
  198. Recall Recovery Cone® Removal System, Bard
  199. Urgent field safety notice for ProcedurePak kits and trays with umbilical clamps IFKR21…
  200. Recall of the camera Endocam Controller from Richard Wolf
  201. Safety Notice for the Bard®ConQuest PTA Balloon Dilatation Catheter, C. R. Bard GmbH
  202. Lot recall of Multi-unit Abutment Plus CC RP 25 mm, Nobel Biocare
  203. Recall of BioMerieux for MRSA ID agar
  204. Recall Slidex Staph Kit, bioMérieux
  205. Recall of all Pleura Flow Catheter Systems of the manufacturer Xeridiem Medical Devices…
  206. Urgent Field Safety Notice for EPIQ Diagnostic Ultrasound System by Philips Medical…
  207. Urgent field safety notice for MDRC-1119 front cover kit, Barco
  208. Corrective action of Cell-Dyn 3700 CS / Cell-Dyn 3700 SL, Cell-Dyn 3500 CS / Cell-Dyn 3500…
  209. Field Safety Notice of the N-DISVENT-02 interface
  210. Recall of VarioLoc / SM straight stern / VarioCup hip prostheses, aap Implantate AG
  211. Urgent Field Safety Notice for TIVA Infusionssystem 2 by Shandong Lee Med Technology Co…
  212. Product Bulletin about PathFinder Cannulated Polyaxial Screwdriver II - Modular, Zimmer…
  213. Recall obturators, Eckert & Ziegler BEBIG
  214. Safety Notice for Avalon Fetal Monitors FM20 and FM30, Philips
  215. Recall of End Screw Extender Sleeves, model 1165-10, Zimmer Spine
  216. Urgent Field Safety Notice for PRECICE System by NuVasive Specialized Orthopedics, Inc., a…
  217. Recall and corrective action of Beckman Coulter for MXP software versions 1.0 and 2.0 for…
  218. Urgent Field Safety Notice for Link Yankauer Sets and Suction Connecting Tubing by Ivor…
  219. Recall for Birdie Patient Hoist, Invacare Aquatec
  220. Advice for electronic wheelchair Allround 960 C, Ortopedia
  221. Information for 2500 PalmSAT pulse oximeters, Nonin
  222. Field Safety Notice concerning the Brainlab Digital Lightbox 2.0, BrainLAB AG
  223. Field Safety Notice concerning a hardware issue of SOMATOM CT, Siemens Healthcare
  224. Safety Notice for the Datascope System 98/98XT, CS100®/CS100i and CS300™ Intra-Aortic…
  225. Urgent Field Safety Notice for INFX-8000C, INFX-8000F, INFX-8000V by Canon Medical Systems…
  226. Recall of patella components of the Genesis Knee System from Smith & Nephew
  227. Recall Stratus CS Cardiac Troponin I Calpak, Siemens
  228. Urgent field safety notice for LINEA stems, Tornier SAS
  229. Recall INNO-LIA Syphilis Score, INNOGENETICS
  230. Safety Notice regarding Patient set REF 000945 for ventilator Novalung vision alpha…
  231. Safety Notice for the STIMPOD Neuromuscular Stimulator, Xavant Technology
  232. Corrective action for Freelite Serum Free Light Chain Assays of The Binding Site
  233. Field Safety Notice concerning 4.0 to 4.0.1 version on the Dental Application of the…
  234. Angiomed recalls Bard® LUMINEXX® 3 Biliary and Vascular Stents and Bard® LUMINEXX® 6 F…
  235. Corrective action of the Elecsys PTH Reagent from Roche
  236. Safety Notice concerning Medumat Transport ventilators, WEINMANN Emergency Medical…
  237. Corrective action for the surgical system drapes manufactured by Microtek Medical used…
  238. Software update of the Legendair ventilators from Airox
  239. Recall for Arrow 4 Fr Peripherally Inserted Central Catheter (PICC) kits, Teleflex Medical
  240. Recall for Vital Signs enFlow IV Fluid Warmer Straps, GE Healthcare
  241. Urgent Field Safety Notice for Chemistry QC Premium Plus by Randox Laboratories Ltd
  242. Recall of Corail AMT HA Femoral Stem Std With Collar Size 11, (3L92501) and Corail AMT HA…
  243. Safety Notice for the STIMPOD NMS450 Nerve Stimulator, Xavant Technology
  244. Recall Venflon, Insyte and Adsyte Pro, Becton Dickinson
  245. Field Safety Notice of X-ray systems Allura XPER FD10 F/C, FD10/10, FD20/10 and FD20
  246. Corrective action for PLT GP/Receptors, Biocytex
  247. Urgent Field Safety Notice for VIDAS High Sensitive Troponin I by bioMérieux SA (Marcy…
  248. Recall of Trabecular Metal Shoulder Instrumenation Distal Pilot Trial by Zimmer
  249. Recall suspension systems J-Bow, Covidien
  250. Safety Notice for the NexGen CR Complete Knee System, Zimmer
  251. Urgent field safety notice for QuikRead go wrCRP and QuikRead go wrCRP+Hb, Enorica GmbH
  252. Safety Notice for CT9000/CT9000ADV Injector Suspension System, Covidien
  253. Safety Notice for Innova 2100IQ, 3100, 3100IQ, 4100 and 4100IQ with InnovaIQ-table, GE…
  254. Corrective action for the Oxford Tibial Tray, Biomet UK Ltd.
  255. Cardiosave Hybrid/Rescue IABP
  256. Medtronic recalls the Lifepak 500 and Lifepak CR Plus
  257. Recall for AVS-TL-Spacer, Stryker
  258. Urgent Field Safety Notice for Double joint struts, OR Adapter, OR-Extension (manufactured…
  259. Urgent Field Safety Notice for TriVerse electrosurgical device by Covidien llc
  260. Unintended Plan Modifications in Acuity or VARiS from Varian
  261. Safety Notice for Volusion E8 Ultrasound Systems, GE Healtcare
  262. Information about specific blood bag systems from Fenwal, Inc.
  263. Urgent Safety Notice for the NeoChord DS1000 device, NeoChord Inc.
  264. 521018bf-5543-9c07-cb7a-e2bad02fcb3e
  265. Recall BioBall ZrO2, Merete Medical
  266. Information for SureSign VS3 Multiparameter Monitors, Philips
  267. Recall of POLYSITE® venous access ports by Laboratoires Perouse
  268. Corrective action for the Clinical Chemistry Phosphorus Assay, Abbott
  269. Urgent Field Safety Notice for Liquid Cardiac Control by Randox Laboratories Ltd
  270. Modern Medical Equipment Manufacturing recalls the Monopolar L-Hook Electrode
  271. Recall for IMMULITE 2000/2500 Chemiluminescent Substrate Lots L2SUBX 253, 254, 255, 256A…
  272. Safety Notice for Eclipse Version 7.3.10, Varian
  273. Recall of BD Vacutainer® Direct Draw Adaptors and BD Vacutainer® Luer Adaptors by Becton…
  274. Corrective action for Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, GE…
  275. Corrective action of Roche for Accu-Chek Active
  276. Field Safety Notice about a problem with the power supply for Terumo APS System 1
  277. Corrective action for the EVIS EXERA III VIDEOGASTROSCOPE GIF-XP190N, Olympus Medical…
  278. Recall of the Concerto™ Bipolar Needle Electrode from Boston Scientific
  279. Safety Notice for Carescape Monitors B850 and B650, GE Healthcare FinlandOy
  280. Urgent Safety Notice for the Rehaforum Rollator with Eurobrake Silver, Rehaforum Medical
  281. Issue in Eclipse version 6.5 from Varian
  282. Safety Notice for Monitor Suspension Systems type GD60-W, MAVIG
  283. Corrective action and recall for the FP1000 Cell Preparation System of Beckman Coulter
  284. Information for Lifepak 12 defibrillators/monitors, Medtronic
  285. Safety Notice concerning transesophageal echocardiography transducer S8-3t Micro TEE…
  286. Urgent field safety notice for VERO / MHI-TM2000 Linear Accelerator System with software…
  287. Urgent Field Safety Notice for SOMATOM Confidence, Edge Plus, Definition Edge, AS by…
  288. Safety Notice for Atlantis Profile Abutments (Ti), DENTSPLY Implants
  289. Corrective action on the Cato anaesthesia machines from Dräger
  290. Safety Notice for Drystar AXYS, AGFA
  291. Safety Notice for MicroScan® Microbiology Systems, Siemens
  292. Advisory notice from Gambro for the Nephral ST dialyzers
  293. Information for BD Visitec TM EdgeAhead TM MVR knife 0,9 mm, Becton Dickinson
  294. Lot Recall for Cortoss Delivery Gun, Orthovita Europe
  295. eNTEGRA
  296. Recall Ultra filters U 8000 S, Gambro
  297. Technical inspection of the SIMPLY seating systems from InterCo
  298. Recall of Abbott for the software of i-Stat analyzers
  299. Urgent field safety notice for TruLab controls and TruCal U calibrator, DiaSys Diagnostic…
  300. Recall of the Cavafix Certo and Cavafix Certodyn catheters, B. Braun
  301. Urgent Field Safety Notice for SMF Stem With Stiktite by Smith & Nephew, Inc.,
  302. Information about an exchange of ABL 77 Cal Packs
  303. Corrective action on volumetric infusion pumps Volumed μVP7000 from Arcomed
  304. Information for Aria Radiation Oncology 8.1 release, Varian
  305. Field Safety Notice concerning X-ray systems Innova 2100IQ, 3100, 3100IQ, 4100, 4100IQ…
  306. Lot recall of reusable electrosurgical snare tube, Olympus
  307. Urgent recall of Temena USB and USC needles, Temena SAS
  308. Corrective action for Ambu Silicone Plus Resusciators from the manufacturer Ambu
  309. Safety Notice for TheraScreen EGFR29 Mutation Kit, DxS Ltd.
  310. Recall of Alcohol Wipes which are packaged with NRG devices, Neuro Resource Group
  311. Urgent Safety Notice for the Ring Applicator Sets (45°, 60°,90°), Varian Medical Systems
  312. Urgent Field Safety Notice for MyCare Insite Clozapine Test Kit by Saladax Biomedical…
  313. Field Safety Corrective Action of Orthofix Srl, Italy, for Prefix - Multi Screw Clamp
  314. Recall of FemSoft® urethral inserts, Rochester Medical
  315. Safety Notice for Constellation Vision System
  316. Corrective action for the Calcium Gen.2 assay, Roche Diagnostics GmbH
  317. Corrective action of Beckman Coulter for Access Immunosystems Unconjucated Estriol…
  318. Safety Notice for ADVIA Centaur Systems Calibrator A, Siemens
  319. Lot Recall for PhaSeal C70 Infusion Adaptor, Carmel Pharma AB
  320. Lot recall of dental adhesive Futurabond NR, VOCO
  321. Safety Notice for the VITROS® Chemistry Products Specialty Diluent, Ortho Clinical…
  322. Urgent field safety notice for Symbia E and e.cam, Siemens Medical Solutions USA Inc.
  323. Urgent Field Safety Notice for CLAW II ORTHOLOC 3DSi Plate/DARCO Screw, Locking by Wright…
  324. Recall of the walking frame NO-0421 (rigidly, folding) from REHNO
  325. Safety Notice for the Aquarius Hemofiltration Device, Nikkiso
  326. Recall of Mast Diagnostics for the Mast ESßL Set
  327. Lot Recall for Nimbus Pico µ, ClearStream Technologies Ltd.
  328. Urgent Field Safety Notice for Dimension Vista System Blood Urea Nitrogen (BUN) Flex…
  329. Recall and updated instructions for use for Lifetech CeraFlex Atrial Septal Defect (ASD)…
  330. Recall of certain lots of the Suction Reservoir Kits, Integra LifeSciences Services
  331. Safety Notice concerning IntelliSpace Portal with software version V4.0, Philips…
  332. Corrective action for Accu-Chek® Advantage, Accu-Chek® Sensor Comfort, Accu-Chek®…
  333. Safety Information for the O-ARM® Imaging System, Medtronic
  334. Recall of Model 7428 Kinetra from the manufacturer Medtronic
  335. Field Safety Notice concerning potential risk of false measurement results of ACUSON…
  336. Urgent Field Safety Notice for TENDON SPACER (SWANSON/HUNTER) and various by Wright…
  337. Recall of several lots of the Cadisc®-L Artificial Spinal Discs, RANIER
  338. Urgent Field Safety Notice for Carescape One by GE Medical Systems Information…
  339. Recall of heat exchangers of the Gambro Integra Dialysis System by Gambro Dasco
  340. Safety Notice concerning Online Substitution Line for Dialog, B. Braun Avitum
  341. Corrective action for BacT/Alert, BioMerieux
  342. Recall of all hand pieces for the VersaCut+ Tissue Morcellator, Lumenis Ltd.
  343. Recall for Intra-aortic Balloon Pumps CS300 and CS100, MAQUET
  344. Urgent field safety notice for Accu-Chek Insight system, Roche Diabetes Care
  345. Recall of certain lots of BARD® DORADO® PTA Dilatation Catheters, Bard Peripheral Vascular…
  346. Batch recall for BIOLOX DELTA REVISION HEAD 12/14 32MM S, Aesculap AG
  347. Recall for i-STAT PT/INR Cartridges (List no. 04J50-01, 04J50-02, Lot no. S09347), Abbott
  348. Urgent Safety Notice/Corrective action concerning RENASYS™ devices, Smith & Nephew Wound…
  349. Lot recall of Cranial Screw PlusDrive ø 1.6 mm, self-drilling, L 3 mm, DePuy Synthes /…
  350. Urgent field safety notice for Hexalon / Trinion / GTR tacks, Inion
  351. Safety Notice for Thermal Ligating Shears, Starion Instruments
  352. Urgent Field Safety Notice for Corpuls 3 by GS Elektromedizinische Geräte G. Stemple GmbH
  353. Urgent Field Safety Notice for Claria MRI/Amplia MRI/Compia MRI/Viva/Brava CRT-Ds/Visia…
  354. Recall of actuators for care beds Casa Med II, Casa Vario T and Casa Comfort II
  355. Safety Notice for EndoBarrier Gastrointestinal Liner, GI DYNAMICS
  356. Urgent field safety notice for LightSheer DESIRE, Lumenis Ltd.
  357. Correct handling and amendment of the Instructions for use of the Merci® Retriever from…
  358. Information regarding VITROS® 5600 Integrated System because of a software anomaly, Ortho…
  359. Corrective action/Recall for IMMULITE 2000 3gAllergy Specific IgE Universal Kit, Siemens
  360. Urgent Field Safety Notice for BD Vacutainer SSTT II Advance Plus by Becton Dickinson and…
  361. Urgent Safety Notice for Escalon Vascular Access Device, Maquet
  362. Urgent Field Safety Notice for Nasal Splints by Exmoor Plastics Ltd.
  363. Safety Notice concerning a problem with the digital linear accelerators of type ARTISTE™…
  364. Corrective action of Cell-Dyn 1700 (all serial numbers) from Abbott
  365. Information about iron (rust) contamination of DI Water in ADVIA® LabCell® System Tubing…
  366. Recall of 5 lots of the Innex Femoral component SC S+ cem. R, Zimmer GmbH
  367. Lot recall for TF Adaptive Gutta Percha Point Size SM3-50 pk, KerrHawe
  368. Recall of Brahms Kryptor Solution 1
  369. Recall of three lots of the HEARTSTRING II Proximal Seal System (HS-1045), Maquet…
  370. Corrective action for the AV Sets with Recirculation System, B. Braun Avitum AG
  371. Recall of one lot of the Amplatz Goose Neck® Snare Kit Model GN3000 from EV3
  372. Recall involving Genesis II Resection Cutting Blocks Size 4 and 5, items 71440116 and…
  373. Software update of the Voluson 730 Ultrasound Product Series from GE Ultraschall
  374. Recall of SPOT-Light HER2 CISH Kit (Lot-No. 849398A), Life Technologies
  375. Lot Recall for Orthofix Spinal Implants Modular Non-Cannulated Bone Taps
  376. Urgent Field Safety Notice for Alere Afinion Lipid Panel Control by Alere Technologies AS…
  377. Urgent Field Safety Notice for SIMEOX_H_EU by PHYSIO-ASSIST S.A.S.
  378. Corrective action and recall of Cepheid Europe for DX Software Smartcycler
  379. Urgent Field Safety Notice for OFFSET NECK PATTERN 8-M by KeriMedical SA
  380. Information about the Multimed Light integrated valve for medical gases from the…
  381. Safety Notice for Precision 500D and Advantx Legacy, GE Healtcare
  382. Field Safety Notice of the haemofiltration apparatus BM25
  383. Lot Recall for the Surfix Screw, NEWDEAL SAS
  384. Urgent Field Safety Notice for Septiflow Circuit by Altera Tibbi Maiz.San.ve Tic.A.S Turan…
  385. Aesculap recalls the products Orthopilot THA Reamer Shafts 40-48 HARR
  386. Corrective action for Synchron Systems C Reactive Protein Reagent, Beckman Coulter
  387. Recall Protégé EverFlex, ev3
  388. Recall of Endurant / Endurant II 23 mm and 25 mm Bifurcated Stent Graft Systems, Medtronic
  389. Recall of OIC Peek Cage, OIC Peek Spacer, AVS Peek Spacer, Solis Peek Cage, Stryker
  390. Lot Recall for Philips Microstream® Infant/Neonatal Filter Line products, Philips…
  391. Urgent Field Safety Notice for Nextra Hammertoe Correction System by Nextremity Solutions…
  392. Bausch & Lomb recalls Amvisc and Amvisc Plus
  393. Urgent Field Safety Notice for V40 BIOLOX delta Ceramic Femoral Head by Stryker…
  394. Angiomed recalls Bard® LUMINEXX® Endoscopic Biliary Stent and Bard® memotherm® Colorectal…
  395. Corrective action and recall for potassium electrodes of the analyzers Hitachi (type 902…
  396. Safety Notice for Brilliance CT Big Bore, Brilliance 64, Ingenuity CT and Brilliance iCT…
  397. Urgent Safety Notice for HOMOCYSTEINE liquiUV, Human Gesellschaft für Biochemica und…
  398. Recall of screw implants by aap Implantate AG
  399. Safety Notice concerning certain Brilliance CT Big Bore, Brilliance 64, Ingenuity und…
  400. Recall IntraCoil, ev3
  401. Field Safety Notice for dialysis systems Gambro AK 200 S equipped with UFD and AK 200…
  402. Safety Notice for the 52-leaf Standard MLC and 52-leaf Millenium MLC, Varian medical…
  403. Safety Notice for XO 4 Suction tube holder on patient's chair, XO CARE A/S
  404. Recall of TMA Archwires, ORMCO
  405. Corrective action for Primedic Charger Basis, Metrax
  406. Recall for Posey Waist and Wrist Restraints
  407. Recall for Jet-Ventilation-Catheters, VBM Medizintechnik GmbH
  408. Urgent Field Safety Notice for VNS Therapy SenTiva Generator by LivaNova, Inc
  409. Recall of Lp(a) Calibrator from Wako Chemicals
  410. Safety Notice concerning incorrect Expiration Date on MMG-226A, MMG-232A, MMG-526A…
  411. Recall for ASP6025, Leica
  412. Information for CyberKnife® System, Accuray
  413. DePuy Synthes: Urgent Safety Information concerning the Guide Wire Ø 3,2mm, length 400mm
  414. Recall for Imager™ II Angiographic catheters and Imager™ II catheters used in urology…
  415. Urgent field safety notice for Artis zee systems with generator A100Plus / Artis zeego…
  416. Lot recall of ACCUFORCE PTCA Dilatation Catheter (φ 2.5 mm), Terumo Corporation / Terumo…
  417. Urgent Field Safety Notice for Hamilton G5 by Hamilton Medical AG
  418. Urgent field safety notice for VERION Reference Unit (Vision Planner), Alcon Eye Care UK…
  419. OrbusNeich recalls Constant SDS
  420. Urgent Field Safety Notice for BD Syringes and Needles by Becton Dickinson France S.A.S.
  421. Information regarding incorrect labelling of the electropalatograph-system WinEPG / PTU…
  422. Urgent Safety Notice: 2.24 programmer software version and Reply / Esprit pacemakers…
  423. Safety Notice concerning Precedence and SKYLight SPECT Systems, Philips Healthcare
  424. Recall Artisan™ controll catheters, Hansen
  425. Notice of Correction concerning Triage® TOX Drug Screen kits, Biosite Incorporated
  426. Urgent field safety notice for da Vinci Si and Xi Touchpad Compact Flash Card, Intuitive…
  427. Urgent Field Safety Notice for WDC Detachement Controller by SEQUENT MEDICAL Inc.
  428. Recall of three lots of the Astron Pulsar Self-Expanding Nitinol Stent System, Biotronik…
  429. Recall of the mattress system “Innova Basic” from KCI Medical Products
  430. Recall of NC464 and NC468T ACETABULAR CUP SC by Aesculap
  431. Recall of the CellSearch Circulating Tumor Cell Kit and the CellSearch Epithelial Cell Kit…
  432. Lot Recall for Le U interspinous spacer, ARCA-MEDICA
  433. Lot recall of Affected Device(s): I.V. Administration Sets with ChemoLock Port, ICU…
  434. Customer Technical Bulletin concerning remote auto motions and differences on…
  435. Safety Notice concerning Intellispace Portal with AutoSpect Pro Application software…
  436. Urgent Field Safety Notice for MR-Set ELS 65ml , ELS 65ml syringe by MEDTRON AG
  437. Stryker recalls further lot numbers of T2 Recon Lag Screw
  438. Information about intraocular lenses X-60 and X-70 from Advanced Vision Science
  439. Urgent field safety notice for iChemVELOCITY automated urine chemistry system using…
  440. Otto Bock: Safety Information for the A200 Power Wheelchair, Skippi / Skippi Plus Power…
  441. Safety Notice for the Ardo Amemnc radiant lamp, Ardo medical AG
  442. Advisory Notice concerning current revision rate data of the ASR System, DePuy
  443. Speaker exchange of VSM vital signs monitors, WelchAllyn
  444. Corrective action/Recall for Dimension Vista with Alpha Technology UPS, Siemens
  445. Laerdal Compact Suction Unit 4 (LCSU 4) - kahanenud imemisvõime
  446. Recall of the Vigilance monitors from Edwards Lifesciences Services
  447. Follow-up/Updates for CellTracks AutoPrep System, Ortho-Clinical Diagnostics / Veridex
  448. Corrective action for the Spectron Multi Med Light valves, Spectron Gas Control Systems…
  449. Safety Notice for XVI R4.5, Elekta
  450. Stryker recalls the Intra-Compatmental Pressure Monitor Systems
  451. Safety Notice for directCheck Whole Blood Control, International Technidyne Corp.
  452. Corrective Action for the Aliquotter Module, Inpeco
  453. Recall for OXOID Giolitti-Cantoni-Broth CM0523, lot 793642, OXOID Ltd./Thermo Fisher…
  454. Lot Recall of the Avenir Mueller Stem, Zimmer
  455. Recall SynchroMed II, Medtronic
  456. Corrective Action for IMMAGE Systems - Buffer 1, Beckman Coulter
  457. Rückruf diverser Combo Reamer Drills, Stryker Osteosynthesis
  458. Storage Information for sterile-packed medical devices, translumina GmbH
  459. Urgent Field Safety Notice for ADVIA Chemistry LDLP and LDPL Reagent by Siemens Healthcare…
  460. Safety Alert for HomeChoice/HomeChoicePro, Baxter
  461. Field Safety Notice concerning the Flexible Probe with Blocking Washer, GM11002420, Varian…
  462. Safety Notice for Image Diagnost (IDI) MammoWorkstation with a licensed IDI Reporting…
  463. Urgent Field Safety Notice for Monopolar Instruments / Bipolar Instrument Handle CEV669E…
  464. Lot recall of sterile procedure packs containing BD Plastipak syringe 100 ml with catheter…
  465. Hill-Rom informs about battery failure in the hand control of the mattress system Duo
  466. Safety Notice for the Optical Guidance Platform, Varian medical systems
  467. Field Safety Notice for GEMSTAR Bolus Cord for use with GEMSTAR Infusion Pumps
  468. Safety-related corrective action for Artis zeego systems, Siemens Healthcare
  469. Information for Oncentra MasterPlan and OTP, Nucletron
  470. Safety Notice for PVC Receptal Liner, Hospira
  471. Safety Notice for Ultrasound Scanners HI Vision Ascendus, Preirus and Avius, Hitachi
  472. Urgent field safety notice for Virage OCT Spinal Fixation System Closure Caps (item number…
  473. Urgent field safety notice for HeartWare ventricular assist device (HVAD) system…
  474. Warning against condom special offers in the Internet
  475. Information for Meliseptol Foam pure, B. Braun Melsungen
  476. Batch recall for BDyn implants, BIOSPINE Implants / S14 Implants
  477. Recall of Carotid Wallstent™ Monorail™ carotid endoprosthesis from Boston Scientific
  478. Urgent Field Safety Notice for BEGO Semados S. 4.5 L8.5 by BEGO Implant Systems GmbH & Co…
  479. Information about the Sonicath Ultra 6, 12.5 MHz Imaging Catheters from the company Boston…
  480. Information for the FilterWire EZ™ Embolic Protection System, Boston Scientific
  481. Recall of Cordis 6 French Infiniti Selective Diagnostic Catheters
  482. Recall of the Boston Scientific IQ Guide Wire
  483. Information for 1.5T Achieva and 1.5T Intera, Philips
  484. Recall for all Non-F-50 Level 1® Normothermic IV Fluid Administration Sets, Smiths Medical
  485. Lot recall of 1/3 tubular plate 3.5 / 2 and 3 round holes, aap Implantate AG
  486. Lot recall of the spine implant CeSpace PEEK, Aesculap
  487. Safety Notice for the syngo Workflow MLR, Siemens AG
  488. Recall of the TLC-II portable VAD drivers from Thoratec
  489. Urgent field safety notice for Lightspeed CT, Discovery ST PET CT and Discovery LS PET CT…
  490. Corrective action PT Link systems, Dako
  491. Urgent field safety notice for TOPAZ MicroDebriders, Smith & Nephew Inc.
  492. Urgent Field Safety Notice for EtCO2 OxyMask by Southmedic, Inc.

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