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International device safety notices

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

  1. Information concerning the Heater Cooler Unit HCU 30 from Maquet
  2. Urgent Safety Notice for the product "Schraubenmodul" (screw module), Litos GmbH
  3. Information for Colleague Triple Channel Pumps, Baxter
  4. Urgent Safety Notice for Philips M3002 IntelliVue X2 and M8102A IntelliVue MP2, Philips…
  5. Corrective action for the PRISMA, PRISMAFLEX, PRISMARS, X-MARS, ADSORBA, SEPTEX and OXIRIS…
  6. Recall of Alcon ACCURUS® STANDALONE VITREOUS PROBES, Alcon Pharma GmbH
  7. Urgent Field Safety Notice for IMMULITE / IMMULITE 1000, Siemens Healthcare Diagnostics…
  8. Urgent Field Safety Notice for ADVIA Centaur Insulin by Siemens Healthcare Diagnostics…
  9. Urgent Field Safety Notice for SARS-CoV-2 antigen IVD, kit, fluorescent immunoass by…
  10. Safety Alert for Cyberonics VNS Therapy Software model 250, Cyberonics
  11. Urgent Field Safety Notice for AMO 20GA Vitrectomy Cutter and Irrigation Sleeve by Abbott…
  12. Urgent Field Safety Notice for ExacTrac Dynamic by Brainlab AG
  13. Recall for syringes intended for contrast media application, Medtron AG
  14. Recall of the Rocker Reducer Instrument from Medtronics
  15. Lot Recall for Level 1 Disposable Normothermic IV Administration Sets, Smiths Medical
  16. Safety Notice concerning use of Mizuho OSI Modular Table Systems, MIZUHOSI
  17. Corrective action for the Neuromuscular Transmission Module Version 01 (E-NMT-01), GE…
  18. Recall of the Generation II Aorfix™ Stentgrafts from Lombard Medical
  19. Recall for the Bartels Legionella Urinary Antigen Kit, Trinity Biotech
  20. Urgent Field Safety Notice for CARTO Vizigo 8.5F Bi-Directional Guiding Sheath by Biosense…
  21. Urgent Field Safety Notice for Original Perfusor Line by B. Braun Melsungen AG
  22. Recall of the Columbia blood agar with CNA from Heipha
  23. Recall for Access Immunoassay Systems HAV Ab Reagent Kit, Beckman Coulter
  24. Recall of Bone Anchors, Axya
  25. Recall for Dimension Vista System BUN Flex reagent cartridges (K1021), Siemens
  26. Urgent Field Safety Notice for Multilevel Plasma Calibrator Set Neuroleptics 1 by…
  27. Information for PV 403 homecare ventilators, Breas
  28. Recall for hydrogel contact lenses, Wöhlk-Contact-Linsen GmbH
  29. Urgent Field Safety Notice for VIDAS FT4 by bioMérieux S. (Marcy- l'Etoile)
  30. Ammendment for Sprint Fidelis Leads, Medtronic
  31. Safety Notice for Ultraview SL 2200, 2400, 2600, 2700 and XPREZZON Monitors with…
  32. Urgent Field Safety Notice for Healon, Healon GV, Healon 5 Pro, Healon Pro by AMO Uppsala…
  33. Urgent Field Safety Notice for Alinity m System by Abbott Molecular, Inc
  34. Recall for Precision Charger 1.0, Boston Scientific
  35. Corrective action for DxH Cell Lyse, Beckman Coulter
  36. Information concerning displacements of annotations by using the MPR-tool on a “portrait”…
  37. Urgent Field Safety Notice for Image Suite 3.0 with Mini-PACS Options and Hot Fix 3004…
  38. Urgent Field Safety Notice for Stealth Chamber by IBA Dosimetry GmbH
  39. Urgent Field Safety Notice for N Antiserum to Human Albumin by Siemens Healthcare…
  40. Urgent Field Safety Notice for CardioMems Hospital and Patient Electronic System by S…
  41. Recall CO2-based cryosurgical instruments, Wallach Surgical Devices
  42. Urgent Field Safety Notice for HF Sensor Delivery System by S.. Jude Medical, Inc…
  43. Field Safety Notice for Pegasus 3-D-System from Biofeedback Motor Control GmbH
  44. Recall for Medena tapered suction tips, Astra Tech
  45. Recall of the Tracheostoma Retainer Set manufactured by Willy Rüsch
  46. Field Safety Notice of AvantGuard beds from Hill Room SAS
  47. Information concerning the using of the GM cervical sleeves with the CT/MR Ring & Tandem…
  48. Urgent field safety notice for LIAISON Multi-Control Tumor Markers, DiaSorin S.p.A
  49. Corrective action for the product Mentype® MycoDerm, Biotype Diagnostik GmbH
  50. Urgent Field Safety Notice for Efficia Pads Adapter Cable by Philips Goldway (Shenzhen)…
  51. Corrective action for the Access Immunoassay Systems Ultrasensitive Insulin Reagent Kit…
  52. Lot recall for Trilly Oxygenator, EUROSETS s.r.l.
  53. Recall of Foliodrape CombiSets, Paul Hartmann
  54. Recall of certain lots of PE biliary stents of the manufacturer Dispomedica GmbH
  55. Batch recall of Distal Plug, Biomet France SARL / Zimmer Biomet
  56. Recall of Liaison CEA (lot number 72101) from DiaSorin
  57. Urgent safety information for steam sterilizer ZIRBUS, ZIRBUS technology
  58. Recall for the OXOID Egg Yolk Emulsion, Oxoid
  59. Urgent field safety notice for Discovery IGS 730 and Discovery IGS 740 systems, GE…
  60. Urgent Field Safety Notice for Movicol Beutel by Norgine BV
  61. Information for PENTRA 400 Software, Horiba Medical
  62. Information concerning several products from Boston Scientific
  63. Corrective action for the Ingenia MR systems, Philips Healthcare
  64. Lot recall of Spongiosaschraube, winkelstabil, D=5.9 mm, L=65 mm, I.T.S. GmbH
  65. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
  66. Urgent Field Safety Notice for Atellica DCA HbA1c Dx Reagent by Siemens Healthcare…
  67. Recall of the Boots brand blood glucometers from Boots
  68. Lot-recall for RC cementable abutment, Institut Straumann AG
  69. Lot recall of intrathecal catheter kits model 8731SC and catheter revision kits model…
  70. Recalls of OP-Mallet with ID code XXX505 or XXX324, Rudolf Medical
  71. Corrective action for the Qube Compact Monitor, Spacelabs Healthcare
  72. Recall for C5L PLATELET SET (5-DAY-STORAGE), Fresenius Kabi
  73. Urgent Field Safety Notice for cMYC (MYC) Breakapart by Cytocell Ltd
  74. Information concerning the RTP-Exchange v6.2, v6.6 & v8.0 from Varian
  75. Recall of heated breathing circuits from Fisher & Paykel
  76. Corrective action of the power cord for Alphaclassic, Alphastar, Betastar and Alphamaxx…
  77. Service Procedure Update Notice for Proteus XR/a and Revolution XR/d systems, GE…
  78. Recall of the ISP-Modularer-Duokopf from ISP
  79. Corrective action for the Salter Labs Oxygen Mask, Salter Labs
  80. Corrective action for the Innova, Optima and Discovery Systems, GE Healthcare
  81. Corrective Action for Cholestech LDX Multi-Analyte Controls, Lipid Controls, and…
  82. Corrective action for the m24sp Instrument, Abbott Molecular Inc.
  83. Boston Scientific: Corrective action for specific CLEARSIGN II Amplifiers, which are part…
  84. Urgent Field Safety Notice for Digital mobile X-ray unit: MOVIX xx DREAM x series by…
  85. Softwareupgrade für TEE/8-3 MHz Sonde am M-Turbo Ultraschallsystem, SonoSite
  86. Urgent Safety Notice for the Artis/Evosys Dialysis System, Gambro Dasco S.p.A
  87. Lot recall for ARCHITECT STAT High Sensitive Troponin-I, Abbott Ireland Diagnostics…
  88. Recall for Radius Urology Examination Chair, Maquet
  89. Corrective action for TRIGEN INTERTAN Nails, Smith & Nephew
  90. Urgent Field Safety Notice for ENCOR probes, Bard Limited
  91. Urgent Field Safety Notice for Bellco MICROPLAS plasmafilters by Bellco S.p.A.
  92. Urgent Field Safety Notice for Welch Allyn Patient Cables and Lead Sets by Welch Allyn Inc
  93. Urgent Field Safety Notice for BodyGuard Microset Infusion Set by Caesarea Medical…
  94. Safety Notice for CADD-Legacy® Duodopa® pumps, Smiths Medical ASD
  95. Urgent field safety notice for DX-D600, Agfa HealthCare NV
  96. Urgent Field Safety Notice for DiMix - ExactaMix - KabiHelp Uno - Nutri Bag by Diffuplast…
  97. Safety Notice on some wrongly mounted locks, Andreas Hettich GmbH & Co. KG
  98. Urgent Field Safety Notice for AssayTip / AssayCup, Roche
  99. Recall for Velocity™ Injection Port and Applier, SAGB Quick Close Swedish Adjustabel…
  100. Recall for the Screwdriver blade Cross-Lock Mid 1.7, Zimmer / Normed Medizin-Technik GmbH
  101. Software error in the Schwind CAM software from Schwind eye-tech-solutions
  102. Recall for Dimension Vista System BUN Flex reagent cartridges, Siemens
  103. Recall for Endopath® XCEL™ with Optiview™ Technology, Ethicon Endo-Surgery
  104. Urgent Safety Notice for the NOxBOXi devices, Bedfont Scientific Ltd.
  105. Lot recall for GEM Microvascular Anastomotic Coupler, Synovis Micro Companies Alliance…
  106. Recall of one batch of CoCr femoral heads, Tornier S.A.S.
  107. Stryker Trauma AG, Division Trauma and Extremities: Corrective action for the products…
  108. Urgent Field Safety Notice for Tru Flu by Meridian Bioscience, Inc.
  109. Recall for BD Visitec™ High Viscosity Injector, Becton Dickinson
  110. Information for the Collegue Volumetric Infusion pumps from Baxter
  111. Recall for Access Immunoassay Systems Total T4 Calibrators, Beckman Coulter
  112. Information for the REMstar heated humidifier from Respironics
  113. Recall of the Anspach single-use cutting burrs, Anspach Effort
  114. Recall for ATEC 1212-20 Handpieces, Hologic
  115. Safety Notice for VITROS® 5600 Integrated System and VITROS® 5,1 FS Chemistry System…
  116. Recall from K-Flow Access Catheters
  117. Recall of mislabeled packaging - Nucleus non-magnetic plug and implant magnet, Cochlear
  118. Lot Recall for the Optilavage Splash Shield, Biomet
  119. Corrective action concerning the ACL TOP Family Coagulation Systems, Instrumentation…
  120. Connection Lead SP (12V)
  121. Biograph mCT systems, Biograph mCT Flow systems
  122. Corrective Action on Cold-Disinfection for CARL ZEISS HYRAX C50, Carl Zeiss MicroImaging
  123. Field Safety Notice concerning a software update of the defibrillators of the Primedic™…
  124. Field safety notice concerning software anomaly identified in TrueBeam, Varian medical…
  125. Corrective Action for enGen Laboratory Automation System, Ortho-Clinical Diagnostics
  126. Recall of the Monoject Insulin Safety Syringe, Covidien
  127. Urgent Field Safety Notice for verschiedene Therapieliegen, Arcus Motor by FREI AG- Aktive…
  128. Lot Recall of the EnduRo meniscal component, Aesculap
  129. Safety Notice for the 23G EDGEPLUS™ non-valved trocar cannula, Alcon Laboratories Inc.
  130. Urgent field safety notice for Accu-Chek Insight insulin pump, Roche Diabetes Care
  131. Information from Stryker of Vision Elect 26-Zoll-HDTV Monitors
  132. Lot Recall of the product CELT ACD (6F) Femoral Artery Vascular Closure Device, Vasorum…
  133. Recall for Histopaque 1077-1, Sigma-Aldrich
  134. Urgent Field Safety Notice for TEM-SCHLAUCHSET by Richard Wolf GmbH
  135. Recall of 20 Gauge Millenium Lightening High-Speed Cutter Tips and vitrectomy packs from…
  136. Model 400.833.04C
  137. Recall of the Innex Tibia Baseplates from Zimmer
  138. Corrective action for the PROCISE EZ View™ with Integrated Cable and EVAC™ 70 XTRA with…
  139. Urgent Field Safety Notice for Incisive CT/MX 16 Slice/Access CT by Philips Healthcare…
  140. Safety Information for the Unicondylar Sled Prosthesis LINK® metal-backed Tibial Plateau…
  141. Field safety notice concerning problem with MPR (Multi Planare Rekonstruktion) Feature of…
  142. Urgent Safety Notice for the wheelchair Quickie Jive UP, Sunrise Medical
  143. Lot recall for Cortex Screw ø 4.5 mm (self-tapping, length 20 mm, pure titanium), DePuy…
  144. Recall for the reagent kit ALPAMP and ALPDEA of the ADVIA system, Siemens
  145. Information concerning the using of the K.S.I. Bauer-Schraube
  146. Safety Notice for MobiMed Clinical Workstation, Ortivus
  147. Risk of hypocalcaemia with AQUARIUS Hemofiltration System (manufacturer: Edwards…
  148. Corrective action for Testosterone Direct RIA Kit, Beckman Coulter
  149. Safety Notice for Koos Ecostar M3, KOOS EDELMETALLE
  150. Urgent Field Safety Notice for VITEK 2 GN ID,VITEK 2 GP ID,VITEK 2 YST ID by bioMérieux…
  151. Information about the safe handling of the ThromCat Thrombectomy Catheter System from…
  152. Corrective Action for MULTIGENT Hemoglobin A1c Reagent, Fisher Diagnostics
  153. Urgent Field Safety Notice for Endo Clinch II Auto Suture Grasper 5mm and Endo Grasp Auto…
  154. Corrective Action for von Willebrand Reagent, Siemens
  155. Field Safety Notice concerning corrective action of defibrillation electrodes for "FRED…
  156. Urgent Field Safety Notice for Neurospeed PTA Ballon Catheter by Acandis GmbH & Co. KG
  157. Safety Notice for Calcuson Ultrasonic Generator / Endomat LC, Karl Storz GmbH & Co. KG
  158. Safety Notice for the FRED easy defibrillators, Schiller AG
  159. Recall of the DLP® Femoral Arterial Cannula product and DLP® Femoral Cannula and Insertion…
  160. Urgent Field Safety Notice for Altius Central Venous Catheter Kit by Kimal Plc
  161. Urgent Field Safety Notice for Monnal T50 by Air Liquide Medical Systems
  162. Urgent Field Safety Notice for Endo-Model Knee Fusion Nail, Femoral, left, Size 1 by…
  163. Corrective action for the ADVIA Centaur® CP, Siemens
  164. Urgent Field Safety Notice for Valor Nail _ 415101020R and 415101115R by Wright Medical…
  165. Recall of the lot number 52044HW00 of Clinical Chemistry Creatine Kinase (CK) from Abbott
  166. Synthes GmbH: Recall for the non-sterile Cortex Screw Diameter 4.5 mm, Length 105 mm, Pure…
  167. Urgent Field Safety Notice for Artis icono and Artis pheno by Siemens Healthcare GmbH…
  168. Safety Notice for coDiagnostiX, Institut Straumann AG
  169. Urgent field safety notice for Aperio eSlide Manager, Leica Biosystems
  170. Safety Notice for HeartStart MRx, Philips
  171. Recall/Corrective Action for TruCal Apo B calibrator set and Apolipoprotein B FS reagent…
  172. Recall for Logicath 12 F Haemodialysis Central Venous Catheters, Smiths Medical
  173. Urgent Field Safety Notice for Arrow Multiple-Lumen Catheter by Teleflex Medical USA
  174. Corrective Action for HemoCue Glucose 201 DM and HemoCue Hb 201 DM Analyzers, HemoCue AB
  175. Recall of Normed Fender Titanium Plates, Zimmer Biomet
  176. Recall of Torque Limiting Adapter, Handles and Screwdriver, Greatbatch Inc.
  177. Urgent Field Safety Notice for Panther Fusion Tube Tray by Hologic Inc
  178. Recall for Scorpio Fixed Femoral A/P-Sizing Guide and Scorpio Adjustable Sizing Guide…
  179. Safety Notice for AMX Series Mobile RAD System Battery Sense Board, GE Healthcare
  180. Urgent Field Safety Notice for Relay Plus and Relay 85 by Bolton Medical lnc.
  181. Urgent field safety notice for teamCRAFT 5, Digithurst GmbH & Co. KG
  182. Information for the Flexor Check-Flo Micropuncture Introducer Sets from William Cook
  183. Field Safety Notice of Forward Water Jet from Advanced Sterilization Products
  184. Recall for Unifusor infusion pressure cuff, CASMED
  185. Lot Recall of the Original-Infusomat line, B. Braun
  186. Corrective action for the Washer-Disinfector of GETINGE Getinge 46-Series (CM302) with…
  187. Recall for Pressure Infusion Cuff 500, Transmed
  188. Software upgrade of the ORTHOPHOS Plus with TSA from the manufacturer Sirona Dental…
  189. Safety Information for all C5L sets, Fresenius Kabi
  190. Recall for Kent Hip Twist Drills, Biomet
  191. Safety Notice for Maquet Heart Lung Machine HL20, Maquet
  192. Safety Notice for the RayStation 2.5 and RayStation 2.5.1, RaySearch Laboratories
  193. Follow-up Information for the Panthera-Puncher 9 instrument, PerkinElmer
  194. Recall of ConMed Linvatec Ultra Power Burs and ConMed Linvatec E9000 Burs
  195. Recall for Celltac α blood analysers, Nihon Kohden
  196. Corrective action for the diagnostic ultrasound system ARIETTA 60 and ARIETTA 70, Hitachi…
  197. Safety Notice for R Series Defibrillator, Zoll
  198. Recall of the adaptor Combifix from the manufacturer B.Braun Melsungen AG
  199. Urgent Safety Notice for Dual-Chamber External Temporary Pulse Generator Model 5388…
  200. Corrective action for the defibrillator-/patient monitoring system corpuls3, GS…
  201. Urgent field safety notice for Biograph TruePoint systems running PETsyngo 6.7.x software…
  202. Recall for Carto® 3 System Interface Cable, Biosense Webster
  203. Safety Notice for OEC 9800 and 9900 X-ray systems (C-Arm), GE Healthcare
  204. Recall for a limited number of batches of the Profile™ Single Use Polypectomy Snare…
  205. Urgent Field Safety Notice for MobileDiagnost wDR 2, Philips Medical Systems
  206. Lot Recall for Microseal Master Cone, SYBRON ENDO
  207. Urgent Safety Notice for Advantage and Seno Advantage Workstation, GE Healthcare
  208. Information about the system PRECISION PLUS® (TUNA®) from Medtronic
  209. Urgent Field Safety Notice for Contec CMS8000 by Contec Medical Systems Co., Ltd.
  210. Recall for proHD set, Fresenius Medical Care
  211. Recall for the Liquick PLUS urological catheter, Medical Service GmbH
  212. Corrective action for the ExacTrac 6.0 Patient Positioning System (Version 6.0.4)…
  213. Recall of the angioplasty catheter type 1 cm Peripheral Cutting Ballon from Boston…
  214. Recall for HeartStart FR2, Philips
  215. Safety Notice concerning shifted Dose for XiO Proton Spot Beams, Elekta
  216. Corrective action for the ProTime Microcoagulation System from ITC
  217. Urgent Safety Notice for the EIT PLIF Shaver, EIT Emerging Implant Technologies GmbH
  218. Lot Recall for the Corail AMT Size 9 und Size 10 Hip Implants, DePuy
  219. Urgent field safety notice for ExacTrac Vero 3.5, Brainlab AG
  220. Urgent Field Safety Notice for WiSE CRT Transmitter by EBR Systems, INC
  221. Recall for the product ProcedurePak®, Mölnlycke Health Care
  222. Safety Notice for Clinac®, Trilogy™and Novalis Tx™ - Warning about the use of Conical…
  223. Corrective action of the Architect i2000sR Processing Module, the Architect i2000…
  224. Recall for the Amplatzer™ Cardiac Plug (ACP), St. Jude Medical
  225. Corrective action for the UniCel DxI Access Immunoassay System with UniCel DxI 800…
  226. Information about TELEGUARD System, GE Healthcare
  227. Corrective action for NIHON KOHDEN Electrocardiographs series "cardiofax m" ECG-2350…
  228. Safety Notice for the contrast media injector system OptiVantage™ DH, Mallinckrodt…
  229. Lot Recall for Philips Disposable Pressure Transducer Kits, Philips Healthcare
  230. Recall for the MIS Setting Device for Pole Plug, Zimmer
  231. Safety Notice for élance Vital Signs Monitor, Spacelabs Medical
  232. Safety Notice for HOSPIRA GEMSTAR™-Dockingstation, Hospira
  233. Recall for Mölnlycke Health Care ProcedurePak®, Mölnlycke Health Care
  234. Safety Notice for Sureshot Targeter, Smith & Nephew
  235. Lot recall of Prostaflow Prostatectomy Catheters PVC Latex, Coloplast
  236. Corrective action for the BD Vacutainer® CPT™ (Cell Preparation Tube), Becton Dickinson…
  237. Software-upgrade of the Lifepak 20 defibrillator from Medtronic
  238. Recall for neck reamer for revision prosthesis, Mathys AG
  239. Urgent Field Safety Notice for INGEVITY MRI by Boston Scientific CRM
  240. Recall of the Imipenem 10 µg Antimicrobial Susceptibility Discs from Oxoid
  241. Urgent Field Safety Notice for RAPIDPoint 500 ROW by Siemens Healthcare Diagnostics Inc…
  242. Recall for Interpulse Systems, Stryker
  243. Corrective action for Advia Centaur Acid and base reagents of Bayer
  244. Urgent Field Safety Notice for Normal Range Trace Elements Control by UTAK Laboratories
  245. New Advisory Notice for Metha Hip Endoprothesis, Aesculap
  246. Urgent Field Safety Notice for Link Spacer Knee by Laboratorios S. S.A.
  247. Information for Linear Accelerator Primus/Mevatron, Siemens
  248. Safety Notice concerning a corrective action of the Armboards for operation tables 10-380…
  249. Safety Notice for Maquet Oxygenators - Blood outlet connector, Maquet Cardiopulmonary AG
  250. Urgent Field Safety Notice for PREC THIN by Stryker Instruments-a division of Stryker Corp
  251. Recall of ENDOPATH ETS Compact Flex 45 mm (240 shaft length) articulating linear cutters…
  252. Information for the Varian High Energy Clinacs with Release 7 Software and the 4 MV/10 MV…
  253. Recall for Redon Drainage Tube, 50 cm, B. Braun Melsungen AG
  254. Urgent field safety notice for Eva Mobile Lifts, Handicare AB
  255. Urgent Field Safety Notice for Combilite by GCE s.r.o.
  256. Uric Acid TBHBA, Enzymatic, colorimetric
  257. Recall for Equalizer™ Occlusion Ballon Catheter, Boston Scientific
  258. Recall for PleuraSeal Lung Sealant System, COVIDIEN
  259. Safety Notice concerning the Eclipse treatment planning system, Varian medical systems
  260. Recall of the Surgical Incise Drape included in Shunt Sets, Fuhrmann GmbH
  261. Safety information for the wheelchair model 1.300 UF from Uniroll
  262. Safety Notice for Centricity Enterprise Archive, GE Healthcare
  263. Recall for EndoClamp Aortic Catheters, Edwards Lifesciences
  264. Recall and extended recall of the Lavanid 1 and Lavanid 2 wound irrigation solution…
  265. Recall for the product respons® Bilirubin Auto Total FS, DiaSys Diagnostic Systems GmbH
  266. Lot Recall for custom procedural trays (CPT), ArcRoyal
  267. Field Safety Notice concerning a corrective action of long-term electrocardiogram (ECG)…
  268. Urgent Field Safety Notice for Sauerstoffmaske für Erwachsene, hohe Konzentration by First…
  269. Recall port systems, Agency for Medical Innovations
  270. Urgent Field Safety Notice for ExacTrac Dynamic by Brainlab AG
  271. Recall of Safe Cut Biopsy Systems from Somatex
  272. Safety Notice for Signa OpenSpeed and Signa Ovation, GE Healthcare
  273. Recall of the Russka walker, Ludwig Bertram GmbH
  274. Corrective Action of TOSOH BIOSCIENCE for Tosoh AIA-PACK ucPA (Catalogue #: 965202) und…
  275. Corrective Action for Natural-Knee Flex System Gender Solutions Prolong Highly Crosslinked…
  276. Recall for the Manual Inhibin A Elisa Reagent Kit, Beckman Coulter
  277. IFU update for the Cook LapSac® Surgical Tissue Pouch, Cook Incorporated, Cook Ireland…
  278. Safety Notice for Oncentra Prostate revision 3.0, Nucletron
  279. Recall for the clavicle plate, anterior, lateral, Königsee Implantate GmbH
  280. Corrective action for the Oxford Femoral Drill Guide Lateral IM Adapter, Biomet…
  281. Urgent Field Safety Notice for SALSA MLPA Probemix P060 SMA by MRC Holland BV
  282. Urgent Field Safety Notice for SPII Model Lubinus - Hip Prosthesis Stem by Waldemar Link…
  283. CMV PCR Tests
  284. Information for Multigas-Analyzer model 91518, Spacelabs
  285. Recall for Universal IVF Medium, Origio
  286. Urgent Field Safety Notice for VANTRIS VUR Treatment by Promedon S.A.
  287. Recall from Respironics of BIPAP Focus ventilators
  288. Lot Recall for Endosgel 20 ml, Farco-Pharma
  289. Urgent Field Safety Notice for Marrow Cellution by Ranfac Corp.
  290. Information concerning the MammoDiagnost Systems from Philips
  291. Software update for the Telemetrie-Systems ApexPro/ApexPro CH from GE Healthcare
  292. Urgent field safety notice for EliA CCP Positive Control, ImmunoDiagnostics / Thermo…
  293. Urgent Field Safety Notice for Rely+On Perasafe by Antec International Limited
  294. Safety Notice: 4D Integrated Treatment Console, Varian Medical
  295. Recall of the lot number SC058 of Capture-R Select from Immucor
  296. Urgent Safety Notice for the Titration Medium Solidscreen II, Bio-Rad Medical Diagnostics…
  297. Corrective action for the XRL Medium Implant Holder, Synthes GmbH
  298. Diagnostic kits for molecular genetic identification of the Mycobacterium tuberculosis…
  299. CARDIOVIT MS-2007; MS-2010; MS-2015
  300. Recall for Dimension Enzymatic Creatinine Flex Cartridge ECRE, Siemens
  301. Safety Notice for ALPHAMAQUET operationg table columns
  302. Corrective action for certain care beds from Hermann Bock GmbH / Replacement of MD201 twin…
  303. Another Safety Notice for the products VIVA II, PRISMA II and MELODY II (Sleep apnea…
  304. Urgent field safety notice for inflation / deflation device GDB-10-30-030, Medi-Globe GmbH
  305. Urgent Field Safety Notice for YSIO X.pree by Siemens Healthcare GmbH, X-Ray Products (XP)
  306. Urgent Field Safety Notice for Test Thrombin Reagent by Siemens Healthcare Diagnostics…
  307. Recall for Reflex Hybrid Screw Extractor Draw Rods, Stryker Spine Bordeaux
  308. Safety Notice for the Young LoTrach ™ Tracheostomy Tubes, Venner Medical (Singapore)
  309. Urgent Field Safety Notice for cobas p501 post-analytical unit and cobas p701…
  310. Recall for i-STAT Celite ACT Cartridges, Abbott
  311. Safety Notice for Brilliance iCT and iCT SP, Philips Healthcare
  312. Recall for BRAHMS PAPP-A KRYPTOR CAL, BRAHMS
  313. XpertXpressCoV-2plus
  314. Urgent Field Safety Notice for t:slim X2 Insulin Pump by Tandem Diabetes Care, Inc
  315. Urgent Field Safety Notice for Original and Essential Kit Pedicle Screw systems by Safe…
  316. Recall for ISKD Intramedullary Skeletal Kinetic Distractor, Orthofix
  317. Recall of Smart Seal Pressurisers, DePuy
  318. Safety Notice for TACSI Bloodcentrifuge, A. Hettich GmbH & Co. KG
  319. Recalls of old version of Drilling Guide for diameter 3,5 mm screws part in Tibiaxys®…
  320. Lot Recall for Breeze Resin Cement, PENTRON CLINICAL
  321. Recall for the Celsite® Access Ports, B. Braun Medical France
  322. Information concerning the operating tables from Trumpf
  323. Urgent Field Safety Notice for Sauerstoffmaske für Erwachsene, hohe Konzentration by Asid…
  324. Information for the soft rubber inflatable blaster, Willy Rüsch
  325. Urgent Safety Notice for the Etest® CEFOTAXIME CT 256, BioMérieux SA
  326. Recall for ON-Q elastomeric pumps with an integrated bolus component ONDEMAND, I-Flow
  327. Field Safety Notice concerning a corrective action of the TruPort ceiling support systems…
  328. Recall of ARCHITECT CA 19-9XR (Lot-No.: 08849M500 - 08853M500, 10122M500 and 10040M500)…
  329. Corrective action for IPS e.max Ceram and related products, Ivoclar Vivadent AG
  330. Safety Notice for the Metal Liner Components of the R3 Acetabular System, Smith & Nephew…
  331. Lot recall of SpeediCath ® Compact Eve CH 12, Coloplast A/S
  332. Recall of sterile markers and kits for surgical navigation from Praxim Medivision
  333. Corrective action for CA 19-9 Kryptor Reagent, Brahms
  334. Risk of gantry collision with patient during automated treatment including couch rotation…
  335. Urgent field safety notice for Novocastra Lyophilised Mouse Monoclonal Antibody Renal Cell…
  336. Lutonix 014 Drug Coated Balloon PTCA Catheter
  337. Field Safety Notice concerning a corrective action of syngo Imaging XS radiologic picture…
  338. Corrective action for LIFEPAK 1000 defibrillators, Physio-Control, Inc.
  339. Urgent Field Safety Notice for cobas b 123 Sensor Cartridge BG/ISE, Roche Diagnostics GmbH
  340. Lot recall for Delicot, American Surgical Company
  341. Safety Notice for Pedicel Screwdriver-Set OASYS, Weber Instrumente
  342. Urgent Field Safety Notice for VentStar Flex 220, ID Circuit Flex 220 by Drägerwerk AG &…
  343. Recall of MebioKnie PE-Inlays, aap Implantate AG
  344. Information for passive sling clips / Lifter of Arjo, Medibo and BHM, Medibo Medical N.V.
  345. Corrective Action for MassTrak Immunosuppressants Kits, Waters
  346. Corrective action for the AMIKA nutrition pump, Fresenius Kabi
  347. Recall Morcellex Tissue Morcellator, Ethicon
  348. Corrective action for the Patient Data Manager 2.0 (versions 2.0.0, 2.0.1, 2.0.2)…
  349. Urgent field safety notice for CENTURION FMS (Fluidics Management System) Pack for…
  350. Recall for Cepheid LightCycler HSV ½ Qual Kit, Roche
  351. Field safety notice concerning recall of AL07368000 Rectal retractor, titanium, white…
  352. Urgent field safety notice for AU system, Beckman Coulter
  353. Recall for Omnitest 3 blood glucose analysers, B. Braun
  354. Corrective action for the 5 ml Reaction Vessels, Abbott Molecular Inc.
  355. Renewed Recall for Input TS Introducer Sets with Needle, Medtronic
  356. Urgent field safety notice for rechargeable implantable neurostimulators RestoreSensor /…
  357. Field Safety Notice for implantable neurostimulators Model Prescision UPN M365SC11100…
  358. Recall for Guide Wire 2.8mm, Length 180mm with Thread, Synthes GmbH
  359. Information of OR table of the MAGNETOM Espree System, Siemens
  360. Safety Notice for Guider Softip™ Guide Catheter, Boston Scientific
  361. Recall of Ortho-Clinical Diagnostics for VITROS Chemistry Products Calibrator Kit 2
  362. Corrective action for CYTO-STAT tetraCHROME, Beckman Coulter
  363. Field Safety Notice concerning a Corpuls 3 Defibrillator/Monitoring systems
  364. Recall of Hintegra Tibial Alignement Rod, Newdeal
  365. Corrective action for the VITROS® 3600 Immunodiagnostic Systems, VITROS® 4600 Chemistry…
  366. Urgent Safety Notice for the product Assy, 2mm and 4mm Offset Femoral Alignment Locating…
  367. Information for bath tube lift "Bellavita", Drive Medical
  368. Recall of Compoflex® and Composelect® bloodbag systems, Fresenius Kabi
  369. Urgent Field Safety Notice for NAVIO Soft Tissue Protector by Smith & Nephew Inc…
  370. Urgent Field Safety Notice for Foliodress Gown by WINNER MEDICAL Co., Ltd. (CY)
  371. Recall for the PathFinder NXT Pivoting Percutaneous Rod Holder Instrument, Zimmer Inc.
  372. Recall for BD Anaesthesia Kits and Epidural Filter, Becton Dickinson
  373. Safety Information: Linet Eleganza Standard and De-Luxe Model Bedframes
  374. Corrective action for GlucoMen LX Sensor test strips, EurimPharm
  375. Software upgrade of the Gambro Prismaflex Continuous Renal Replacement System from Gambro
  376. Recall of hindfoot fusion nails of the TriGen system from Smith & Nephew
  377. Recall for INNEX tibia inserts FIXSC, Zimmer
  378. Recall of PathFinder NXT Fixed Rod Holder Instrument, Zimmer
  379. Recall of Peri-Loc locking plates from Smith & Nephew
  380. Recall of the Subtrochanteric Lag Screw Driver from Smith & Nephew
  381. Safety Field Notice of Otologics LLC, Boulder, Colorado, USA, for Middle Ear Implants…
  382. Corrective action for the Direct Radiography system DX-D 600, Agfa HealthCare NV
  383. Information from Edwards Lifesciences of Vigilance II Monitors
  384. Recall for Thoratec HeartMate II and HeartMate XVE LVAS, Thoratec Corp.
  385. Urgent Field Safety Notice for BD Vacutainer Plus Citrate Tube by Becton Dickinson and…
  386. Urgent Field Safety Notice for Lunar Prodigy by GE HEALTHCARE INTEGRATED IT SOLUTIONS Inc
  387. Urgent Field Safety Notice for SYNTHESIS by CUTTING EDGE SAS
  388. Corrective Action for Cholestech LDX, Alere
  389. Recall of control unit model PowerLink3 from Rehavista
  390. Recall for MB Redox 4 ml, of heipha Diagnostika
  391. Lot Recall for the Alumina Femoral Ceramic Head- V40 Taper +0,0 mm, Stryker Orthopaedics
  392. Batch Recall for the product E.Motion FP Meniscal component F5R 12mm, Aesculap AG
  393. Urgent Field Safety Notice for M1 Ambulance Co. by Stryker Medical-Kalamazoo
  394. Recall for Dimension Vista Cuvettes, Siemens
  395. Urgent Field Safety Notice for TRx4851A 2.4 GHz / TRx4841A 1.4GHz IntelliVue Tel. by…
  396. Urgent Field Safety Notice for Azurion by Philips Medical Systems Nederland B.V.
  397. Field Safety Notice for Minstrel, Minerva, Gemini and Excelsior, ArjoHuntleigh
  398. Urgent Field Safety Notice for OAKWORKS Inc., Multi-Movement Imaging Tables by OAKWORKS…
  399. 89c262d2-ebe8-2f60-c102-62a749aa873c
  400. Corrective action for the Philips Ultrasound Q-Station software, Philips Healthcare…
  401. Lot recall of VELOX 3 cc, InnoTERE GmbH
  402. Urgent Field Safety Notice for Cios Spin by Siemens Healthcare GmbH, X-Ray Products (XP)
  403. Urgent Safety Notice for the products Gelweave™, Thoraflex™ Hybrid, BioValsalva™ Stentless…
  404. Urgent Field Safety Notice for Cios Alpha by Siemens Healthcare GmbH, X-Ray Products (XP)
  405. Recall for cobas c pack large D-Dimer, Roche
  406. Safety Notice for Infusionpumps: Volumed µVP7000 Premium / Classic Plus / Lite and Syramed…
  407. Lot recall of TRUEresult Blood Glucose Test Strips (GDH-FAD), Nipro Diagnostics / Nipro…
  408. Safety Notice for the Leica M525 F50 surgical microscope, Leica
  409. Safety Notice for Voluson E6 and Voluson E8 Diagnostic Ultrasound Systems, GE Healthcare
  410. Recall for the product “20310 - Disposable Bite on Mouthpiece medium (50)”, Vitalograph
  411. Recall of rope lock Axis, Redcord AS
  412. Urgent Field Safety Notice for PADSY-Holter by Medset Medizintechnik GmbH
  413. Recall for CROSSOVER™ Sheath Introducer, Cordis
  414. Lot recall of CELL-DYN Emerald Cleaner, Abbott Laboratories
  415. Urgent Field Safety Notice for Stamey Needle,Clarke-Reich Laparoscopic Knot…
  416. Information for Mosaiq, Elekta Impac Software
  417. Safety Notice concerning a corrective action of the Magnetic Resonance Imaging System MSK…
  418. Batch recall of R3° 0 Degree XLPE Acetabular Liner 32 mm ID X OD 48 mm, Smith & Nephew…
  419. Urgent Field Safety Notice for Dimension, Dimension Vista by Siemens Healthcare…
  420. Urgent Field Safety Notice for NeuMoDx Cartridge by NeuMoDx Molecular, a QIAGEN Company
  421. Field Safety Corrective Action Notice for the Stryker System 6 and Cordless Driver 3…
  422. Corrective action and recall of INNO TPHA 100, Newmarket Laboratories
  423. Recall for Komet bone milling cutter H162SL, Gebr. Brasseler
  424. Urgent Field Safety Notice for Epstein- Barr virus EA IgM ELISA by IBL International GmbH
  425. Recall of Clinitest hCG Cassettes, Siemens
  426. Recall for HMRS Humerus Head Fixed and HMRS Distal Humerus Cone, STRYKER
  427. Recall for Innex Tibial clamp, Zimmer
  428. Urgent Field Safety Notice for V60 Ventilator by Respironics California, Inc.
  429. Urgent Field Safety Notice for MEDILOOPS by Neuromedex GmbH
  430. Information for the patient hoists Foldy, Torneo and Duo, Aktuelle Krankenpflege Systeme
  431. Safety Notice for the HeadFIX® system, Elekta
  432. Corrective Action for ABL80 FLEX and ABL80 FLEX CO-OX analyzers, Radiometer
  433. Information for the Carendo Multi purpose Hygien Chair, Arjo
  434. Recall for Bard Magnum Disposable Biopsy Core Needles, C.R. Bard
  435. Recall/Corrective action for ADVIA Centaur CP, Siemens
  436. Urgent Field Safety Notice for Select Myoelectric Hand by Hugh Steeper Ltd
  437. Corrective action for the Hospital bed "Seta" suitable for mechanical cleaning, Joh…
  438. Safety Notice for Bicarbonate FS, DiaSys Diagnostic Systems
  439. Urgent Field Safety Notice for RT Elements by Brainlab AG
  440. Recall of AED 10 defibrillators, Welch Allyn
  441. Recall for Vapotherm Precision Flow®, Disposable Patient Circuit, RMS
  442. Recall for Gravity Compensating Accessory, Integra Neurosciences
  443. Lot Recall for DUET TRS Universal Straight and Articulating Single Use Loading Unit (SULU)
  444. Recall for Quatrix® Aspheric Evolutive Yellow IOL, Croma Pharma
  445. Safety Notice for MAGNETOM Systems, Siemens Healthcare
  446. Urgent Field Safety Notice for GeneProof Mycoplasma genitalium/hominis PCR Kit by…
  447. Recall of Synchron Systems Salicylate Reagent, Beckman Coulter
  448. Corrective action for the Prelude® Sheath Introducer, Merit Medical Systems, Inc.
  449. Recall for Excelsior™ SL-10 Microcatheter, Boston Scientific
  450. 717a2dd4-9658-7618-c578-9e2cb8f32cd4
  451. Recall for TOTAL PSA FASTPACK, Qualigen
  452. Lot recall of PRECISE PRO RX Nitinol Stent System, Cordis
  453. Urgent Safety Information for klinoPORT, Trumpf
  454. Corrective action of certain automated external defibrillators (AEDs), Cardiac Science…
  455. Urgent Safety Notice for the ATTUNE® INTUITION™ Tibial Articulation Surface Instruments…
  456. Relief ACP Oral Care Gel
  457. Recall for DePuy G2® cementless hipstem, DePuy
  458. Corrective action for AQT90 FLEX TnI and TnT assays in connection with AQT90 FLEX βhCG…
  459. Safety Notice for ASX control unit, Novacare
  460. Urgent Field Safety Notice for APOLLOblue (24V) by LAP GmbH Laser Applikationen
  461. PRAC meeting highlights 24-27 October 2022
  462. Smiths Medical Level 1 Fast Flow Fluid Warming System, Level 1 NORMOFLO Irrigation System…
  463. Urgent Field Safety Notice for AIR Anterior Array by GE Healthcare Coils
  464. Corrective Action of Siemens Healthcare Diagnostics Inc. for Dimension Vista System V-LYTE…
  465. Precedence SPECT/CT Imaging System
  466. Lot Recall for Kryptonite Bone Cement, Doctors Research Group
  467. Information for X-Ray Systems with Monitor Ceiling Suspension, Philips
  468. Lot Recall for Sarns High-flow Aortic Arch Cannulas and Sarns Flexible Arterial Cannulas…
  469. Urgent field safety notice for Dialog+ Dialysis Machines with Software version 9.15 and…
  470. Urgent Field Safety Notice for MATCH IT! DNA software by immucor GTI Diagnostics, Inc.
  471. TomoTherapy has issued a Field Safety Notice about a possible error in the irradiation by…
  472. Update of the Instructions for Use for Dental Handpiece (ruixin) RXGBK, YUYAO RUIXIN…
  473. Corrective action for the product 3M™ ESPE™ Lava™ Ultimate CAD/CAM Restorative, 3M ESPE…
  474. Information for CelonLab POWER, Celon
  475. Lot Recall for the Sarns™ Antegrade Cardioplegia Cannula, Terumo Europe NV
  476. Urgent Field Safety Notice for Origin Data Management, 3.1 by Brainlab AG
  477. Safety Notice for FRED professional Defibrillator, Schiller
  478. cf58f00c-5c4d-8240-632e-0127b478f6cf
  479. Lot recall of various sterile-packaged knee and hip implants, Zimmer Biomet
  480. Absent wedge filter following plan load to Varian Treatment verify and record system…
  481. Safety Notice concerning a corrective action of the radiotherapy planning system Eclipse…
  482. Urgent field safety notice for Automated Enzyme Immunoassay System / Analyzer, Tosoh…
  483. Recall for CELLTRACKS Analyser II, Veridex
  484. Recall for IMMULITE / IMMULITE 1000 Total T3 Kit, Siemens
  485. Information for Brilliance BigBore CT scanner, Philips
  486. Urgent field safety notice for Revolution CT, GE Healthcare
  487. Information for central bathing areas without scalding protection, ArjoHuntleigh
  488. Urgent Field Safety Notice for DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent…
  489. Corrective action for BD Multitest CD3/CD16+56/CD45/CD19 with BD Trucount Beads, Becton…

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