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International device safety notices

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

  1. Urgent Field Safety Notice for Centricity High Acuity (CHA) C.C and Anesthesia by GE…
  2. Safety Notice for the Equipment Carts and Isolation Transformers on behalf of the company…
  3. Recall 3DKnee Tibial Insert Trials, Encore Medical
  4. Recall for 1x4 Deep Brain Stimulation Extension Kit, Medtronic
  5. Safety Notice for the EOS system, EOS imaging
  6. Recall Pulmonetic Ventilator, CardinalHealth
  7. Safety Notice for CT Scanner Presto and ECLOS, Hitachi
  8. Corrective action for Immulite® 2000, Immulite® 2000 XPi and VersaCell™, Siemens
  9. Information of the STERRAD® 50 System and STERRAD® NX™
  10. Safety Notice for Ovation MR Scanner, GE Healthcare
  11. Recall for SynFix-LR Mini-Open Screwdriver, Synthes
  12. Corrective action for actim CRP dipsticks, Medix Biochemica
  13. Urgent Field Safety Notice for Strata II, Delta and Flow Control Valve by Medtronic Inc
  14. Urgent field safety notice for THIOGLYCOLATE BROTH + RESAZURIN, bioMérieux SA
  15. Recall for the Rüsch Bronchopart® bronchial tubes, Teleflex Medical
  16. B. Braun recalls Coroflex Blue Coronarstent-systems
  17. Maintenance schedule for the powered surgical handpiece, bur guard or attachment from…
  18. Urgent Field Safety Notice for ABL9 by Radiometer Medical ApS
  19. Warning regarding COLLOSS E from OSSACUR
  20. Recall for Wright Medical’s SHANNON BURR XL 2.0mm x 20mm, Wright Medical UK
  21. Safety Notice for COGNIS CRT-D and TELIGEN ICD, Boston Scientific
  22. Corrective Action for VENTIlogic LS, Weinmann
  23. Weight limits for Modular-Plus hip revision stems from Plus Orthopedics
  24. Recall Vanguard Width Checker 67.5/75 Sizing Wings, Biomet
  25. Information for Visage CS 3.1, Visage Imaging
  26. Recall for the GENESIS II non-porous Tibial Baseplate, Smith & Nephew
  27. Information about Puritan Bennett 840 Ventilator Systems from Tyco Healthcare
  28. GE Healthcare: Urgent Safety Notice for Infinia, Infinia Hawkeye, Millenium VG, VG Hawkeye…
  29. Corrective action for the ADVIA Centaur XPT System, Siemens Healthcare Diagnostics
  30. Safety Notice/Corrective action for HeartStart MRx (M3535A/M3536A), Philips Healthcare
  31. Urgent Field Safety Notice for BenchMark Ultra by Ventana Medical Systems, Inc
  32. Information about VAC Abdominal Dressing from the manufacturer KCI Medical Products
  33. Corrective action and recall of the AxSYM Ultrasensitive hTSH II Reagent from Abbott
  34. Safety Notice for Axiom Sensis XP, Siemens Healthcare
  35. Linvatec recalls the PowerPro® Electric II Modular Handpiece
  36. Lot recall of clip applicator, MTW-Endoskopie W. Haag KG
  37. Corrective action and recall Synchromn LX20 and Synchron LX20 Pro Clinical Systems…
  38. Recall for Endobon bloc 12.5 and Endobon bloc 20, Biomet
  39. Safety Notice for the Lucas 2 Chest Compression System, Medtronic Physio-Control
  40. Risk in cleaning the centrifuge door of the Amicus Separator from Baxter
  41. Gerätebau Felix Schulte recalls Iris lamps Planilux
  42. Safety Notice for Allura FD10 and FD10/10 X-ray systems, Philips
  43. Lot Recall of a Tubing set for Blood Purification, Naniwa Rubber Co. Ltd.
  44. Safety Notice for View Point with software version 5.6.6 and 5.6.7, GE Healthcare
  45. Urgent Field Safety Notice for Donor N3512, Immucor Medizinische Diagnostik GmbH
  46. Safety Notice for Brilliance 64, Philips
  47. Recall of ENDOEYE HD II Video Telescope, OLYMPUS
  48. CMA/Microdialysis recalls the CMA 61 Hepatic Microdialysis Catheters
  49. Counterfeit of Spectrum TPH -compule tips from Dentsply De Trey
  50. Safety Information for EP-4 Computerised Cardiac Stimulator, St. Jude Medical
  51. Safety Notice for LED battery insert for Heine Standard F.O. Laryngoscope Handle with LED…
  52. Corrective action for the product BioPath™ 035 - Model BPTH-35-60100L, Biosensors Europe…
  53. Corrective Action for ADVIA 1650 and ADVIA 1800 Chemistry Systems, Siemens
  54. Safety Notice for SINUX Nucleus Replacement, SiniTec
  55. Smiths Medical Deutschland: Safety Notice for Medex Custom Packs containing BD Plastipak…
  56. Recall of the catheter scurement devices from Unomedical
  57. Urgent field safety notice for monitor mounts and support arms with rotatable 75 / 100…
  58. Urgent Field Safety Notice for UNISEPTA FOAM 2 WIPES by USF Healthcare SA
  59. Urgent Field Safety Notice for PK Cutting Forceps, 5MM, 33CM by Gyrus ACMI - Olympus…
  60. ETHICON recalls the Portaccess 100 cm, Endoclamp Aortic Catheter
  61. Corrective action of the FP1000 Cell Preparation System from Beckman Coulter
  62. Lot Recall for Compression Connecting Screw, Synthes
  63. Field Safety Corrective Action for PROTIME lnRhythm System / PT Test Cuvettes, Accriva…
  64. Corrective action of the AxSYM Digoxin III reagent from Abbott
  65. Recall for Brilliance MRSA, Oxoid
  66. STP 420D, STP 420ES
  67. QuikClot® Interventional Hemostatic Bandage™ CE – English, n/slit with 3M™ Tegaderm™…
  68. Correction of LIFEPAK® 12 und LIFEPAK® 20, Medtronic
  69. Safety Notice for the sterile INSPIRE Custom Pack, Sorin
  70. Alinity m HCV AMP Kit
  71. Corrective action for pocH-100i haematology analyzers of Sysmex
  72. Recall for Hydra „Blue“ Hydrophilic Coated Nitinol Guide Wire, OptiMed
  73. Corrective action/Recall of Siemens for Dimension Vista Chemistry 2 Calibrator, Siemens
  74. Recall of SeeOne 73 monthly contact lenses from Lenscare
  75. Safety Notice concerning the use of one batch of the product i-Visc 1.6, i-Medical…
  76. Urgent Field Safety Notice for ProxiDiagniost N90 by Philips Medical Systems DMC GmbH
  77. Recall of the FlexCath™ Steerable sheaths from CryoCath
  78. Safety Information for Flashlight PC-ECG, Medset
  79. Recall of disposable imaging device accessories: tubing and syringes, Covidien
  80. Urgent Field Safety Notice for MAKO RIO Spare Part Ethernet-Fiber Optic Converter by MAKO…
  81. Urgent Field Safety Notice for IDS-iSYS ACTH by Immunodiagnostic Systems Ltd
  82. Stop of use of SoFi implants from the company Synthes
  83. Packaging error of Spirit MB Brackets from SDS Ormco
  84. Lot recall of SPOTCHEM II Glucose / SPOTCHEM II PANEL-1 und SPOTCHEM II PANEL-V, ARKRAY…
  85. Recall for ETI-ANA Screen Catalog - N0093, DiaSorin
  86. Urgent Field Safety Notice for patient transport Shuttle with Trendelenburg fast…
  87. Becton Dickinson has recalled BD 25 G Spinal Needles
  88. Corrective action for the HemoCue Glucose RT system and the Hemocue Glucose 201 DM RT…
  89. Safety Notice for Varian Clinac® accelerators with Mark or Millennium MLC and BrainLAB m3…
  90. Field Safety Notice for Accutron MR, Medtron AG
  91. Update for the Instructions of Use (IFU) and Clinical Use Information for the Parachute…
  92. Urgent field safety notice for OS4 surgery system with Endolaser, Oertli Instrumente AG
  93. Lot Recall for PlivioPore spine implants, SYNTHES
  94. Recall of Suture Passer from Smith & Nephew
  95. Corrective action of Mardx Diagnostics for the T. Pallidum IgM Marblot test system
  96. Corrective action for Galileo Echo Blood Bank Analyzer, Immucor
  97. Corrective action of the samaritan PAD 500P public access defibrillators, HeartSine…
  98. Recall of various products due to possible endotoxin contamination, LivaNova PLC (Sorin…
  99. Corrective action of Trinity Biotech for Bartels Legionella Urinary Antigen
  100. Rückruf Burette Sets, Codan
  101. Safety Notice for radiotherapy treatment planning software iPlan RT Dose, BrainLab
  102. Safety Notice for Spirit 3000 Dental Chair, Pelton & Crane
  103. Urgent Safety Notice for TruSat Pulse Oximeter, GE Healthcare
  104. Recall for Infinity™ Glucose Hexokinase Liquid Stable Reagent, Fisher Diagnostics
  105. Safety Notie for the DRB1-13 SSP UniTray, Allset Gold Plus SSP, Life Technologies
  106. Corrective action for Etest Ertapenem test strips, BioMerieux
  107. Urgent Field Safety Notice for Etest Polymyxin B PO 0.064-1024 B30 by bioMérieux S…
  108. Recall of monitor cable EV2-000086 (EinsteinVision 3D-Endoscopy Systems), Schölly…
  109. Corrective Action for AxSYM Free T4 Standard Calibrators, Abbott
  110. Safety Notice for the S4 Cervical Occiput screw remover and removal shaft, Aesculap
  111. Recall of cobas c pack CA (Lot-No. 630204-01 and 631376-01), Roche
  112. Lot Recall of the user-specific Foliodrape CombiSets for ophthalmologic surgery, Paul…
  113. Urgent Field Safety Notice for Cardioband by Edwards Cardioband
  114. Urgent Field Safety Notice for C-Section Tray and Sectio Set by Mölnlycke Health Care AB
  115. Endorec medical devices (reference MTERPACK)
  116. Chad Therapeutics recalls the Sequoia Oxymatic OM-311 and OM-312 electronic oxygen…
  117. Urgent Field Safety Notice for PrisMax Hemodialysis Machine by Baxter
  118. Refit of walking aid Nurmi Neo Ergonomic Walker, Otto Bock
  119. Urgent Field Safety Notice for Elecsys CA 19-9 by Roche Diagnostics GmbH
  120. Recall for Neoject Plus Safety Syringe, Dispomed Witt
  121. Urgent Field Safety Notice for WOmed by Wolf-Medizintechnik GmbH
  122. Urgent Safety Notice for Intracranial Stent "SILK", Balt
  123. Safety Notice for Greenlight II Laryngoscope Handle and Battery Cartridge, GE Healthcare
  124. Clinico recalls the Vasodrop Cannula
  125. Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by…
  126. Urgent Field Safety Notice for PrisMax Hemodialysis Machine by Baxter
  127. Corrective action for the Sealing Screw Tibia UC, Peter Brehm GmbH
  128. Sony recalls LCD -monitors
  129. Information for the AngioJet thrombolytic system, Possis
  130. Recall for ThromboType® plus-Kits, Hain Lifescience
  131. Urgent Field Safety Notice for LE-Cage by OHST Medizintechnik AG
  132. Urgent Field Safety Notice for VIDAS NT-proBNP2 by bioMérieux S. (Marcy- l'Etoile)
  133. Urgent Field Safety Notice for HydroSoft-3D-AV by MicroVention, Inc
  134. Important Information for the RespiFinder SMART 22 FAST v2.0, RespiFinder RG Panel…
  135. Urgent Field Safety Notice for NC Trek RX and NC Traveler RX by Abbott Vascular, Santa…
  136. Zimmer recalls two lots of the Dynesys Torque Driver 450
  137. Corrective action for IMMULITE 2000/IMMULITE 2000 XPi products, Siemens Healthcare…
  138. Lot recall of Super Arrow-Flex Percutaneous Sheath Introducer Set, Arrow International…
  139. Recall for Sekusept Extra N, ECOLAB
  140. Corrective Action for Triage TOX Drug Screen, Biosite
  141. Össur recalls the prosthetic knees Total Knee
  142. Recall for Wiseguide Guide Catheter, Boston Scientific
  143. Recall of the Carotid Wallstent™ Endoprosthesis with Monorail™ Delivery System from Boston…
  144. Urgent Field Safety Notice for ApexPro Telemetry System, CIC Pro Clinical Information…
  145. Corrective action for the Practix Convenio Mobile X-ray system, Philips Medical Systems
  146. Information for Essenta DR X-ray systems, Philips
  147. Corrective action for the Philips Allura Xper, Philips Healthcare
  148. Safety Notice for all GE Healthcare CT scanners, GE Healthcare
  149. Urgent field safety notice for V Gripp Nova Variceal Ligation System, Indus Medical…
  150. Recall of the device Zenith from Cook
  151. Corrective action for Screen-Cyte 3 %, Medion Diagnostics
  152. Safety Information for the use of the Kern Lifter Scales, Kern & Sohn GmbH
  153. Corrective action for the Allura systems (Actuator Monitor Ceiling Suspension), Philips…
  154. Guidant recalls ABSOLUTE™ .035
  155. Corrective action for the Allura systems, Philips Healthcare
  156. Lot Recall for A00348 PLIF Cage, SPONTECH
  157. Additional Information for the Altrus® Thermal Tissue Fusion Handpieces, ConMed
  158. Urgent Field Safety Notice for NovaStar plus, Nova Star TS by Drägerwerk AG & Co. KGaA
  159. Lot recall for Trinity Acetabular Shell, Corin Limited
  160. Batch recall of Helioseal Clear, Ivoclar Vivadent AG
  161. St. Jude Medical recalls Cardiac Positioning System CPS Direct SL, slittable CRT lead…
  162. Safety information for mint Lesion™ version 2.4 and 2.6, Mint Medical GmbH
  163. Lot recall for PVC Trocar catheter CH 24, Redax SpA
  164. Urgent Field Safety Notice for Medumat Standard 2 by WEINMANN Emergency Medical Technology…
  165. Corrective action for the GAP Endo-Exo Medullary System, Pega Medical
  166. Urgent Field Safety Notice for syngo RT Therapist 4.3.1_MR2 with Digital Linear…
  167. Urgent Field Safety Notice for Pilling CLEAR ADVANTAGE Disposable Aortic Punch by Teleflex…
  168. Lot recall of CEA / CD66e Ab2, Thermo Fisher Scientific
  169. Urgent Field Safety Notice for Snaplink Buccal Tube, 18° 0° 12° by Ormco Corporation
  170. Urgent Safety Notice for the BRAHMS Fast Screen pre I Plus, BRAHMS GmbH (part of Thermo…
  171. Urgent Field Safety Notice for Xpert GBS by Cepheid
  172. Corrective action for the Architect Stat Troponin I from Abbott
  173. Safety Notice: Update of the instructions for use of the ELEVATE Apical and Posterior…
  174. Urgent Safety Notice for AvantGuard® Beds, Hill-Rom
  175. Software update for Precision 500D X-ray systems, GE Healthcare
  176. Safety Notice for Awl 2,5mm with Trocar Tip, Synthes
  177. Safety Notice for VIGO patient’s lifting handle, Joh. Stiegelmeyer
  178. Recall of Beckman Coulter for SYCHRON Gentamicin Reagent (GEN) lot M804552
  179. Urgent Field Safety Notice for Giraffe Blue Spot PT Lite by Datex-Ohmeda, Inc
  180. Information for VAPR Electrodes, DePuy Mitek
  181. Important Information for the Ovation Prime™ Abdominal Stent Graft System, TriVascular
  182. HDI4000 Diagnostic Ultrasound System, Model/Catalog HDI4000
  183. Corrective action and recall for Glucose HK MOD P/D R2, Roche
  184. Leonhard Lang KG: Important Safety Notice for the ECG electrodes Skintact, Cardionetics…
  185. Recall of the Joline Acute Dialysis Catheters, Joline GmbH & Co. KG
  186. Urgent Field Safety Notice for Two-Lumen Central Venous Catheterization Kit/ - Set with…
  187. Safety Notice for Unilect™ ECG Electrodes, Unomedical
  188. Safety Notice about the use of Wellion insulin reservoirs together with AccuChek FlexLink…
  189. Safety Notice for Oncentra Brachy, Nucletron
  190. Varian ecalls the Flexible Implant tube, blind end
  191. Safety Notice for the Anaconda™ und Anaconda ONE-LOK™ Stent Grafts, Vascutek Ltd.
  192. Lot Recall of a trocar catheter for pleural drainage, P. J. Dahlhausen & Co. GmbH
  193. Urgent field safety notice for Flexion Port 300 / 350 / 400, Richard Wolf GmbH
  194. Recall for fT3-CTK Kit, DiaSorin
  195. Urgent Field Safety Notice for Agile Biliary RX Fully Covered Stent System by Boston…
  196. Urgent Field Safety Notice for Calcar Trimmer Shaft by Biomet UK Ltd
  197. Lot recall for Fassier-Duval Telescopic IM System, Pega Medical
  198. Urgent field safety notice for MitraClip Clip Delivery System, Abbott Vascular
  199. Urgent Field Safety Notice for AXIUS Blower Mister by Maquet Cardiovascular
  200. Recall and corrective action for Vitros Chemistry Products RF Reagent of Ortho
  201. Urgent Field Safety Notice for COBRA Fusion 150 Minimally Invasive Ablation System by…
  202. Recall of Software and Urgent Field Safety Notice according to HeartAssist 5 LVAS…
  203. Recall of NaviStar® RMT ThermoCool® Irrigated Tip Catheter, Biosense Webster
  204. Recall for Accu-Chek Mobile Blood glucose meters, Roche
  205. Urgent Field Safety Notice for Rüsch EndoGuide T by Teleflex (Perak West Malaysia)
  206. Recall for laparotomie set "Foliodrape CombiSet", Paul Hartmann
  207. Lot Recall for GRYPHON™ BR Suture Anchors, DEPUY MITEK
  208. Recall of ETI-VCA-G (Lot-No.: 3010580A, 3010580A/1, 3010580A/2), DiaSorin
  209. Corrective action of x-ray systems from Philips
  210. Information for the Cogent-4 Field Following Study, Boston Scientific
  211. Recall of one lot of femoral Modular Neck System, DJO Surgical (formerly Encore Medical)
  212. Recall of Rhino Fiberscope Sheath, Medical Technical Promotion GmbH
  213. Recall of Aquasil Ultra Monophase from Dentsply Caulk
  214. Urgent Safety Notice for Alcon Custom Paks / Becton Dickinson´s Microlance 30 G Needles…
  215. Information for iSitePACS 3.6.28.0 and 4.1.17.0, Philips
  216. Corrective action for the da Vinci Si EndoWrist® One Vessel Sealer and da Vinci Xi…
  217. Safety Notice for OPMI VISU 200 / retinal protection filter, Carl Zeiss Surgical
  218. Recall of the „Datacha Tip Multi- Use Laparoscopic Instruments“ by ConMed
  219. Corrective action for Dimension Digitoxin of Dade Behring
  220. Safety Notice for HeartMate II LVAS System Controller, Thoratec Corp.
  221. Safety Notice for Ceros Putty, MATHYS
  222. Urgent Field Safety Notice for 611P CT Lucia by Carl-Zeiss-Meditec AG
  223. Lot Recall for Instinct Java Persuader, Zimmer Spine
  224. Safety Notice for the ExacTrac 6.0 Patient Positioning System, Brainlab AG
  225. Recall of Synchron Systems Vancomycin Reagent, Beckman Coulter
  226. Recall for MarrowStim Kit, Biomet
  227. CareLink Programmer
  228. t:slim X2 Insulin Pump with Control-IQ Technology
  229. 6bdf1d21-343f-d116-21b4-503ff4b9f27b
  230. Surgical instruments for minimally invasive laparoscopic interventions
  231. Stellaris PC Vision Enhancement System with Laser
  232. Integrity
  233. ATTUNE® INTUITION™ IMPACTION HANDLE AND IMPACTORS
  234. Sterile Single Use Prodimed Medical Devices
  235. 1f28ea77-ec77-5754-e25d-8d29af7aeba6
  236. Generator Gen11
  237. 7 French Aspirator
  238. ADROIT 6F Guiding Catheter
  239. Accu-Chek Guide (FCN) Kit
  240. Rocket Medical Rocket KCH Fetal Bladder Drain - juhised õigeks käsitlemiseks
  241. Chemistry Calibrator
  242. GE Healthcare Logiq P6 skannerid (mudelid BT07, BT09) - sondipea pealispinna temperatuuri…
  243. Venue go cart
  244. Dimension Vista High Sensitivity Troponin I Flex
  245. Secura VR
  246. BrightSpeed Excel Select, BrightSpeed Edge Select, BrightSpeed Elite Select BrightSpeed…
  247. PINN 100 W/GRIPTION
  248. CORE
  249. GenomEra GBS Assay Kit
  250. Contak Renewal 4 AVT
  251. Abbott Alinity m System - UUENDATUD viivitatud või valed testitulemused
  252. Blood donor set, quad-pack
  253. Randox Laboratories Ltd. Serology ToRCH Igm Positive Control - uus kasutusjuhend…
  254. ARCHITECT Active-B12 (Holotranscobalamin)
  255. SynchroMed II Clinician Programmer Application
  256. TruSystem 7000
  257. IPP-ON implant sterile
  258. HeartWare Ventricular Assist System - HVAD Pump Implant Kit
  259. Lot Recall for Flow Selector PM1000, Precision Medical Inc.
  260. Safety Notice for the Optima CT580 or Discovery CT590RT scanner, GE Healthcare
  261. Corrective action for the INRatio System of Hemosense
  262. Information concerning the Level 1 from Smiths Medical
  263. Safety Notice for Wayne pneumothorax and pleural sets or trays, Cook Inc.
  264. Recall for the Columbus Revision knee endoprosthesis, Aesculap AG
  265. Field Safety Notice to BD Plastipak 50ml Luer Lok Syringes, Mölnlycke Health Care relates
  266. Safety Notice for the Clinical Chemistry Analyzer ILab Taurus Systems, Instrumentation…
  267. Recall for Dyonics 25 Tube Sets, Smith&Nephew
  268. Urgent Field Safety Notice for ACP215 / MCS+9000 / MCS+8150 / PCS2 devices, Haemonetics…
  269. Recall for Clinical Chemistry Albumin BCG (AlbG), Abbott
  270. Urgent field safety notice for MEDUCORE Easy battery packs, WEINMANN Emergency Medical…
  271. Baxter informs about several issues of application of the volumetric infusion pump…
  272. Urgent field safety notice for digital linear accelerators of type ARTISTE / ONCOR /…
  273. Urgent Field Safety Notice for MyCare Insite Clozapine Test Kit by Saladax Biomedical…
  274. TEVA recalls the Ven-O-Lit I.V. cannula
  275. Risk of entrapment in siderail from Hill-Rom
  276. Recall of the products 585039 Irrigating Cystotome curved (Joyce), 40 x 16 mm from Becton…
  277. Urgent Field Safety Notice for 3MT Bair HuggerT Warming / Cooling Blanket by 3M Health…
  278. Safety Notice for the Cannabinoids (cTHC) Drug of Abuse (DAU) Controls, Lin-Zhi…
  279. Urgent Safety Notice for the treatment tables AXXIS, GYM and THERAGYM, FREI AG
  280. Uni-Gold, H. Pylori Rapid Antigen Test
  281. Urgent field safety notice for ProcedurePak with umbilical clamps IFKR08, Mölnlycke Health…
  282. Lot recall of LASEREDGE 2.0 mm x 2.0 mm Trapezoid Angled 6/Box, Valeant Pharmaceuticals…
  283. Urgent Safety Notice: Product counterfeiting neodisher Septo 459, Chemische Fabrik Dr…
  284. Urgent field safety notice for Drive Gas Check Valve on certain Anesthesia products, GE…
  285. Medical Device
  286. Recall for 3M Disposable Surgical Gown and Reinforced Disposable Surgical Gown, 3M Medica
  287. Urgent Field Safety Notice for AQT90 FLEX Test Kit Boxes and CAL Cartridges, Radiometer
  288. Urgent field safety notice for digital linear accelerators of type PRIMUS / MEVATRON…
  289. Recall for Architect Trigger Level Sensors of Abbott
  290. Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
  291. Information about Innova 2100 IQ, 3100/3100 IQ und 4100/4100 IQ Systems from GE Healthcare
  292. Safety Information for monopolar electrodes mentioned in table 1, Reger Medizintechnik…
  293. Urgent Safety Notice for the phenox p64 ® Flow Modulation Device, phenox GmbH
  294. Urgent field safety notice for ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK, PENTAX Europe GmbH
  295. Recall for Ultrapro Mesh, Johnson & Johnson
  296. Supplement to Corrective Action (BfArM 1017/12 of 2012-03-06) for Vista Magnesium Flex…
  297. Safety Notice for nMARQTM Circular and Crescent Irrigated Catheter, Biosense Webster
  298. Urgent field safety notice for Offset Cup Impactor Universal, Brainlab AG
  299. Urgent Field Safety Notice for CAT Combat Application Tourniquet, schwarzGeneration…
  300. Recall for CALIBRATOR 80, ARKRAY
  301. Recall for the FlexCath® Select Steerable Sheath (10 French), Medtronic
  302. Lot recall of Valleylab Laparoscopic Handset Four-Function, Medtronic
  303. Recall of warming blanket of the Geratherm OP-Warming System, Geratherm Medical Diagnostic…
  304. Urgent Field Safety Notice for STA - VWF:RCo by Stago
  305. Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics…
  306. Information concerning the OEC 9900 Systems from GE Healtcare
  307. Recall for Retroflex Introducer Sheath Set, Edwards Lifesciences
  308. Lot recall of LEGION CRUCIATE RETAINING NARROW Femoral Component SZ 5 RT, Smith & Nephew…
  309. Urgent field safety notice for monitor assembly with HASEKE suspension arm, MAVIG GmbH
  310. Lot recall of Safil Violet 2/0 (3) 12x45 cm, B. Braun Surgical S.A.
  311. Safety Notice for syngo plaza, Siemens Healthcare
  312. Information for ScanGel products, Bio-Rad Laboratories
  313. Lot recall of Monosyn undyed 7/0 (0,5) 45 cm DSMP7, B. Braun Surgical S.A.
  314. Urgent field safey notice for MiniMed 640G Insulin Infusion Pump, Medtronic
  315. Safety Notice for the physical exercise Genius ECO body tension, Frei AG
  316. Corrective Action/Recall for UniCel DxH 800 Coulter Cellular Analysis System, Beckman…
  317. Recall of Trigen™ Meta™ Semi-Extended Drill Guides, Smith & Nephew, Inc.
  318. Urgent Safety Notice for the Perfectha Derm products line / Becton Dickinson´s Microlance…
  319. Urgent field safety notice for iChemVELOCITY automated urine chemistry systems, Beckman…
  320. Recall of Guide Catheters type ZUMA and Launcher from the manufacturer Medtronic
  321. Corrective action: 14.8-Volt Lithium Ion Battery for use with the Philips HeartStart MRx…
  322. Urgent Field Safety Notice for Drainage bag by Ningbo Luke Medical Devices Co
  323. Lot recall for CA500 Epix Universal Clip Applier, Applied Medical Europe BV
  324. Safety Notice: Needles for injection available in the kit of product M-HA 18, Laboratoires…
  325. Safety Notice for Advantage Workstation Reporting Tool, GE Healthcare
  326. Corrective action for Thermo Scientific Indiko and Indiko Plus analyzers, Thermo Fisher…
  327. Recall of Sterile Wand Covers, Smiths Medical
  328. Safety Notice for table brumaba L/Standard and model 2002, Brumaba
  329. Corrective action for the Optiplex Borrelia IgM Test, Diamex
  330. Urgent Field Safety Notice for Philips ear thermometer by Philips Consumer Lifestyle B.V.
  331. Correct application of the chest belt from Cosmos
  332. Lot Recall of the “M.R.I. Implanted Port“ port system, BARD
  333. Urgent Field Safety Notice for Restoris® MCK Onlay Insert Extractor by MAKO Surgical…
  334. Corrective action of Roche for Cobas Amplicor HBV Monitor Test HBM Test Definition File
  335. Recall for Elecsys Troponin I and Troponin I STAT, Roche
  336. Corrective action for Kitpack, Lohmann & Rauscher
  337. Recall for Op-Flex Poole, OP-set Poole, OP-handle Pool, Unomedical
  338. Urgent Field Safety Notice for MOSAIQ Oncology Information System by Elekta Solutions AB
  339. Product error of Damon 3 Bracket from SDS Ormco
  340. Information concerning the IMPAX 5.x MA3000 Breast Imaging review workstation from AGFA
  341. Recall of the ACT-LR-cuvettes, Technidyne Corporation
  342. Recall for the Dimension clinical chemistry system COC of Dade Behring
  343. Recall Portex® Blue Line Ultra, Smiths Medical
  344. Urgent field safety notice for Strata II / Strata NSC Valves (including Burr Hole and…
  345. Urgent Field Safety Notice for URF-P6 URETERO-RENOFIBERSCOPE by Olympus Medical Systems…
  346. Corrective action of Dade Behring for Stratus® CS Analyzer
  347. Urgent field safety notice for Discovery MR450 narrow bore 1.5T MRI, GE Healthcare
  348. Lot recall for defibrillation electrode, Leonhard Lang GmbH
  349. Urgent field safety notice for 3M™ Tegaderm PICC CVC Securement Device + CHG I.V…
  350. Recall for R3 Biolox® Forte Ceramic Liners, Smith & Nephew
  351. Urgent Field Safety Notice for Dornier Gemini by Dornier MedTech Systems GmbH
  352. Edwards recalls LifeStent NT self-expanding stents
  353. Recall of Blood Line Systems (Single-Needle) for dialysis machines, Serumwerk Bernburg…
  354. Urgent Field Safety Notice for MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP by Baxter…
  355. Urgent Field Safety Notice for Ethanolamin IgG/IgM ELISA by IBL International GmbH
  356. Urgent Field Safety Notice for 3 TO 1 DERMACARRIER (FOR USE WITH MESHGRAFT II TISSUE…
  357. Information for iViewGT 3.4 Service Pack 2, Elekta
  358. Urgent Safety Notice for the Philips HeartStart MRx Monitor/Defibrillator, Philips Medical…
  359. Urgent Field Safety Notice for Alinity ci-series System Control Module (SCM) by Abbott…
  360. Field Safety Notice concerning update of the previous Medical Device Correction from…
  361. Urgent Field Safety Notice for Enzygnost Syphilis by Siemens Healthcare Diagnostics…
  362. Corrective action from Roche Diagnostics GmbH for calibration parameters with MODULAR…
  363. Problem with backup unit of CARDIOHELP-i, the manually operated CARDIOHELP Emergency Drive…
  364. Urgent Field Safety Notice for Motec Wrist Radius Cup 15 mm by Swemac Innovation AB
  365. Zimmer recalls Innex anchorage stem
  366. Recall of the scooter Strider Maxi 4 with serial numbers EV10FA-GM 01650 to EV10FA-GM…
  367. Information concerning the Sprint Fidelis lead models 6930, 6931, 6948 and 6949 from…
  368. Urgent Field Safety Notice for REAL by Mercado Medic AB
  369. Corrective action of the Signal Acquisition Module from Boston Scientific
  370. Recall of ConMed Linvatec Hall Surgical Blades, ConMed Linvatec
  371. Corrective action for Advia Centaur XP, Siemens
  372. Urgent Field Safety Notice for WIP'ANIOS PREMIUM/ WIP'ANIOS EXCELTRAVEL by Laboratoires…
  373. Urgent Field Safety Notice for WEB Detachment Controller (WDC) by MicroVention, Inc.
  374. Recall of the PadPro Adult Radiotranslucent defibrillation electrodes 2516Z and 2516M from…
  375. Safety Notice for Philips M1657B Water Trap, used on Gas-Modules M1013A IntelliVue G1…
  376. Smith Medical recalls the Portex Spinal Epidural Needle Sets
  377. Recall of DiaPlastin from the manufacturer Diamed
  378. Safety Notice for syngo.plaza, Siemens Healthcare
  379. Possible corrosion of the tungsten coils from BALT Extrusion
  380. Delphi recalls the IVantage® Infusion System
  381. Retrofit with the wheelchair model Kimba Spring from Otto Bock
  382. Corrective action of Lifepak 500 AED from Medtronic
  383. Recall VAMP Jr. system, Edwards Lifesciences
  384. Corrective action for the Hudson RCI® SHERIDAN SHER-I-BRONCH® Endobronchial Tube, Teleflex…
  385. Urgent Field Safety Notice for GC80 by SAMSUNG ELECTRONICS Co., Ltd.
  386. Safety Notice for PROCARE Monitors B20 or B40, GE Healthcare
  387. Safety Notice for the FIAB Disposable electrodes for Defibrillation series F7965, FIAB SpA
  388. Information for the BD Hydrocath Assure™ Central Venous Catheter from Becton Dickinson
  389. Recall and replacement of instruments in Mobile Bearing Knee System instrumentation sets…
  390. Information concerning the catheters with iridium-192 wires from Eckert & Ziegler BEBIG
  391. Safety Notice concerning SonRtip endocardial pacing lead with contractility sensor, Sorin…
  392. Recall of diverse bone screws and plates, Zimmer
  393. St Jude Medical recalls Agilis Steerable Introducers
  394. Urgent Field Safety Notice for cobas p 512 pre-analytical system, Roche
  395. Urgent Field Safety Notice for Steeclo PWD 8626 und Steelco PWD 8628 by Miele & Cie. KG
  396. Safety risk in the wheelchair control item DX-ACC5 of Dynymic Controls from Invacare
  397. Information about raised toilet seat “Soft”, Russka
  398. Recall for ProcedurePak, Mölnlycke Health Care
  399. Corrective action for Siemens Factor VIII chromogenic assay on CS Series Automated Blood…
  400. Field Safety Notice concerning Dräger Devapor Vaporizers, Dräger
  401. Urgent Field Safety Notice for 10MM FLEXTUBE NEO RESUS B/S WITH VARIABLE PEEP, DO by…
  402. Information for the Fiamm Sealed Lead Acid Batteries in IVAC® P Series Infusion Pumps from…
  403. Safety Information for Factor II (Prothrombin) G20210A Kit, Roche
  404. Corrective action for the ISKD - Intramedullary Skeletal Kinetic Distractor (Limb…
  405. Recall for Sirus Tibia Intramedullary Nail, Zimmer
  406. Urgent Field Safety Notice for PALAMIX UNO; PALAMIX DUO by Heraeus Medical GmbH
  407. Damage to the insulation of the Scissor Insert from Richard Wolf
  408. Correction of the temporomandibular joint program TM 4, SIRONA
  409. Urgent Field Safety Notice for SoKINOX/SERViNO by Maquet Critical Care AB
  410. Recall Xvoid Kyphoplastie Systems, Sintea Biotech
  411. The manufacturer The Surgical Company informs of the warming cassette of a Fluido TA 500…
  412. Urgent Safety Notice for the Neo-Base Non-derivatized Assay Solutions, PerkinElmer
  413. Information about Mitsubishi Diamond Scan CRT displays, GE Healthcare
  414. Corrective Action for i-STAT cTnl, BNP and CK-MB cartridges, Abbott
  415. Urgent Field Safety Notice for Olympus ETD PAA Premium by Miele & Cie. KG
  416. Advisory Notice from Guidant for the RX ACCUNETTM Embolic Protection System
  417. Recall Volaris S3 Premium, Walz
  418. Safety Notice for Monaco treatment planning software, Elekta CMS Software
  419. Urgent field safety notice for QUIK-COMBO pacing / defibrillation / ECG electrodes with…
  420. Urgent Field Safety Notice for Cortical Screw 3.5 by aap Implantate AG
  421. Urgent Field Safety Notice for Recugel by Bausch & Lomb GmbH
  422. Safety Information concerning the Proteus XR/a, Revolution XR/d and Definium 8000 X-ray…
  423. Aesculap recalls Orthopilot THA C fixation clamps and Orthopilot THA sets
  424. Recall of stainless steel block end vapofills, Southmedic
  425. Urgent Field Safety Notice for Rotor-Gene Q by QIAGEN GmbH
  426. Information about the use of the Amplatzer Septal Occluder from AGA Medical
  427. LifePearl microspheres
  428. Getinge Servo-u, Servo-u MR, Servo-n - häiresignaalid ja ventilatsiooni seiskumine
  429. Lot Recall for "Monoaxial pedicular screws" Odalys, KISCO
  430. Safety Notice for Intellivue Patient Monitors, Philips
  431. Recall for the ProAQT Sensor, PULSION Medical Systems SE
  432. Corrective action for Lipase (LIP) Flex reagent cartridge (DF55A), Siemens
  433. Lot Recall for the product Biomet Bone Zement V, BIOMET
  434. Safety Notice for IONTRIS VA, Siemens Healthcare
  435. Recall of Diamed Diagnostika for ID-Heparin/PF4 Antibody Test
  436. Corrective action of the OneTouch Ultra and OneTouch Horizon test strips from Lifescan
  437. Recall for Xience V Everolimus Eluting Coronary Stent System, Abbott
  438. Safety Notice for the Terumo Advanced Perfusion System 1: Occluder and Air Bubble Detect…
  439. Urgent Field Safety Notice for Powerheart G3 Elite AED by Cardiac Science Corp.
  440. Merckle Recordati GmbH informs about a recall
  441. Recall for the HbA1c APT reagent, Beckman Coulter
  442. Urgent Field Safety Notice for Scewo Bro V1 by Scewo AG
  443. Urgent Field Safety Notice for ORBIS Medication by DH Healthcare GmbH
  444. Recall of Proximate PPH Hemorrhoidal Circular Staplers from Ethicon Endo-Surgery
  445. Urgent Field Safety Notice for Damon Q2 by Ormco Corporation
  446. Information for FastPlan versions 5.5 and 5.5.1, Varian medical systems
  447. Recall for Architect cSystems, Abbott
  448. Recall of Babix holder at VS wallstands of BuckyDiagnost, EasyDiagnost and DigitalDiagnost…
  449. Urgent Safety Notice for the RM Pressfit cup vitamys® und seleXys® Inlay vitamys®, Mathys
  450. Corrective action for scooters Maxi 4 and Midi 4 plus, Days Healthcare
  451. Safety Notice for Units klinoPORT and incarePORT, Trumpf
  452. Information for head sections, Trumpf
  453. Cordis recalls the Powerflex™ P3 PTA Balloon Dilatation Catheter
  454. Problems with implanted PTFE -grafts used with the Recover® RD from Impella
  455. Exchange of plates for adjusting camber in wheelchairs model Avantgarde from Bock
  456. Information concerning the PolarCath™ Peripheral Dilatation System - Inflation unit from…
  457. Recall of StarClose SE Vascular Closure System, Abbott Vascular Deutschland GmbH
  458. Urgent field safety notice for BTV (Bag to Ventilation) Switch Issue on Carestation 600…
  459. Recall for HemaCarotid Knitted Ultra Thin Patch, InterVascular
  460. Recall of the biopsy instruments Fischer Cone Biopsy Excisor from Apple
  461. Recall for chloride electrodes for Advia Clinical Chemistry Systems, Siemens
  462. Urgent Safety Notice for the HeartStart XL Defibrillator/Monitors, Philips Healthcare
  463. Lot recall of KAMRA ACI 7000 Corneal Inlays, AcuFocus Inc.
  464. Software upgrade concerning the HeartStart MRx from Philips
  465. Counterfeit products Z100 MP and Filtek Z 250 from 3M Espe
  466. Recall for TDx/TDxFLx Methothrexate II Reagent of Abbott
  467. Corrective action for Magna Pure 96 Instruments, Roche
  468. Recall orthodontic wire, Highland Metals
  469. Safety information to pay attention to correct use of medical apparatus G-scan, Esaote…
  470. Safety Notice concerning TumorLOC in Brilliance CT Big Bore, GEMINI TF 16 and 64 Slice…
  471. Urgent Safety Notice for the HeartStart MRx Monitor/Defibrillators, Philips Healthcare
  472. Safety Notice for the Primus RS Worksimulator, BTE Technologies, Inc.
  473. Urgent Field Safety Notice for ADVIA Centaur / Centaur XP / Centaur XPT / Centaur Systems…
  474. Information concerning the Miele washer-disinfectors G 7823 to G 7828
  475. Urgent field safety notice for Artis zee systems with specific delivery losts of the…
  476. Recall for Targon PF Aiming Bow, Aesculap
  477. Problems with the MR images from Accuray
  478. Recall for Coulter LH 500 Series Analyzer, Coulter HmX Hematology Analyzer and HmX…
  479. Lot recall of Heliosphere Newtech, Helioscopie Medical Implants / M + C Medizingeräte…
  480. Urgent Field Safety Notice for PROVERT by PROTEC GmbH & Co. KG
  481. Urgent field safety notice for Nellix EndoVascular Aneurysm Sealing System, Endologix Inc.
  482. Urgent field safety notice for Elecsys TSH / PTH, Roche Diagnostics
  483. Further Safety Information for the HeartStart MRx Monitor/Defibrillators, Philips…
  484. HeartStart FR3
  485. Information for Infinia, GE Healthcare
  486. Corrective action and recall for AutoVue Innova and AutoVue Ultra software version 1.02…
  487. Corrective Action for ADVIA Centaur and ADVIA Centaur XP Vitamin D (VitD) Assay (Test…
  488. Safety Notice concerning the HeartMate II LVAS Pocket System Controller, Thoratec Corp.
  489. Baxter recalls the 6060 Pumps
  490. Safety Notice for Flexima and Percuflex Drainage Catheters, Boston Scientific
  491. Security advice for Revitan Disassembly Instruments, Zimmer
  492. Corrective action of the HeartStart MRx Monitor/Defibrillators, Philips Healthcare
  493. Safety Information for angle-stable distal femoral plates, KÖNIGSEE IMPLANTATE
  494. Safety Notice for UniCel® DxH ™ 800 COULTER® Cellular Analysis System, Beckman Coulter
  495. Lot Recall of the impression material AlgiNot FS Volume, Kerr Italia S.r.l
  496. Urgent Safety Notice for the HeartStart MRx Monitor/Defibrillators with Q-CPR Meter…
  497. Recall for PO5090A-Chocolate Agar with Vitox, Oxoid
  498. Recall of one lot of surgical blades, Hygeia Medical Co. Ltd
  499. Recall for TV5005I - Selenit-Lactose-Broth, Oxoid
  500. Urgent Field Safety Notice for BD syringes/Needles Pennine used in Custom Procedure Packs…
  501. expiratory valve might fail, Servo Ventilator 300, Maquet
  502. Urgent field safety notice for Artis systems with software versions VC14 / VC21 / VD10 /…
  503. Safety Notice for Accu-Check Spirit insulin pumps, Roche
  504. Recall of FasT- Fix, Smith & Nephew
  505. Information about CENTRA Active hearing instrument from Siemens Audiologische Technik
  506. Urgent Safety Notice for "ViaCath" diagnostic catheters, VascoMed

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