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International device safety notices

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

  1. Safety Notice for Desktop Pro™ R7.01, Elekta
  2. Recall of the BD™ Sensi-Disc™ Ticarcillin TIC-75 susceptibility discs from Becton…
  3. Safety Notice for Aisys and Avance Anaesthesia Machines, GE Healthcare
  4. Recall for Alpha-Fit Stem, Corin
  5. Safety Notice for Hamilton-G5 and Hamilton-S1 ventilators, Hamilton Medical AG
  6. Safety Notice for the product DePuy CMW2 Gentamicin Bone Cement, DePuy Synthes
  7. Safety Notice for BV Libra, BV Endura and BV Pulsera mobile X-ray systems, Philips
  8. Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
  9. Urgent field safety notice for Prism S / XP / NewTec / MultiCam eco, Inter Medical…
  10. Urgent Field Safety Notice for Vivid i, Vivid q, Vivid S., Vivid S. by GE Medical Systems…
  11. Safety Notice for the Triathlon® PKR Instruments, PEG Drill, Stryker Orthopaedics Mahwah
  12. Information for the MODUS® MDO 1.5 Le Fort I distraktor from Medartis
  13. Information about MOSAIQ version 1.30 and 1.40, IMPAC
  14. Safety Notice for zinc-containing denture adhesives, GlaxoSmithKline Consumer Healthcare…
  15. Recall of Salter Labs Oxygen Mask, Salter Labs
  16. Urgent Field Safety Notice for Altair and Roomer S by Human Care HC Sweden AB
  17. Lot Recall of the L-Varlock Cage/trial implantat holder, Kisco International
  18. Information concerning the Ambu PEEP 10 reusable valves from Ambu A/S
  19. Recall Infectogripp, Infectopharm
  20. Lot Recall for Dermabond Skin Adhesive, Ethicon
  21. Information for Affinity, Hill Rom
  22. Safety Notice for Panta nail support device (Surgical Technique), Newdeal SAS
  23. Lot Recall for sterile twisted gauze swabs, Urgo GmbH
  24. Urgent Field Safety Notice for MiniCollect Complete 1 ml 9NC by Greiner Bio-One GmbH
  25. Urgent field safety notice for MRI-System OASIS, Hitachi Ltd.
  26. Recall for the awl of the cosmicMIA spinal implantation system, Ulrich Medizintechnik
  27. Corrective Action for ABL80 FLEX CO-OX Analyzer, Radiometer
  28. Urgent Field Safety Notice for HRIS ACET CUP CUT TIP by Stryker Joint Replacement
  29. Problems with some LCD displays of the Cell Saver 5, Cell Saver 5+, and MCS+ 9000 from…
  30. Corrective Action for i-STAT Hematocrit/HCT and Calculated Hemoglobin/HB Cartridge and…
  31. Urgent Field Safety Notice for Multi Stage Esophageal Dilation Balloon by Endo-Flex GmbH
  32. Recall for VASOVIEW 6 Endoscopic Vessel Harvesting System kits, MAQUET
  33. Error in software catalog number 71070401 for external fixator Spatial Frame, Smith &…
  34. Lot Recall of the Cortex Screw, Synthes
  35. Recall Leukosan Skin Staplers, BSN Medical
  36. Recall of the HEARTSTRING II Proximal Seal System from MAQUET Cardiopulmonary AG
  37. Urgent field safety notice for DRX-Revolution Mobile X-Ray System, Carestream Health
  38. Urgent Field Safety Notice for Prevail Paclitaxel-coated PTCA Balloon Catheter by…
  39. Recall for DARCO(R) Cannulated Hex Driver, Wright
  40. Lot recall of Oxford Bearing, Biomet
  41. Corrective action for various products for inhalation therapy, Teleflex Medical
  42. Recall of the Matrix2™ Detachable coils from Boston Scientific
  43. Recall of Alcohol pads and swabsticks, VWR International GmbH
  44. Safety Notice for the Bead Block (Embolic Bead) device, Biocompatibles UK Ltd.
  45. Urgent field safety notice for Acetaminophen L3K Assay, Sekisui Diagnostics
  46. Recall and corrective action of Ortho Clinical Diagnostics for Mitis 2 System Software
  47. Information for Evolution beds, Hill Rom
  48. Safety Notice for Targon PFT Step Drill and Targon PFT Depth Stop, Aesculap AG
  49. Corrective action for Alere Triage® TOX Drug Screen, Alere
  50. Recall of Salter Labs 7600 Bubble Humidifier, Salter Labs
  51. Urgent Field Safety Notice for PSPIX by SOPRO
  52. Recall Easypump, I-Flow
  53. Safety Notice for Brilliance 6, 10, 16, 16P, 40, 64, Big Bore, iCT and iCT SP, Philips
  54. Urgent Field Safety Notice for Automated Enzyme Immunoassay Analyzer AIA-360 by Tosoh…
  55. Urgent Field Safety Notice for Perfusor Space by B. Braun Melsungen AG
  56. Exchange of control units of Berlin Heart INCOR implantable ventrikel assist devices
  57. Ev3 recalls the XSizer® Thrombectomy-Catheter System
  58. Recall for Nova StatStrip Glucose Test-Strips, Nova Biomedical
  59. Urgent Safety Notice for PleurX™ Drainage Kits, CareFusion
  60. Safety Notice for XiO, Elekta CMS Software
  61. Urgent Safety Notice for THERAKOS™ UVAR XTS™ Procedural Kits, Therakos Inc.
  62. Urgent Field Safety Notice for ARTIS pheno by Siemens Healthcare GmbH Advanced Therapies
  63. Advise from Minntech for the Renatron II Dialyzer Reprocessing Machine
  64. Safety Notice for FRED Easyport - Automated External Defibrillator, Schiller
  65. Safety Notice for Primedic™ HeartSave Series, Metrax GmbH
  66. Recall of NIOX MINO NO monitors from Aerocrine
  67. Lot Recall of the totally implantable venous access system PORT PUR Katheter 6Fr…
  68. Urgent Field Safety Notice for Universal Femoral Sleeve (S-ROM Noiles Rotating Hinge Knee…
  69. Urgent field safety notice for ETEST XM256 (Cefuroxime), bioMérieux SA
  70. Operating Table TITAN
  71. Recall of the products Pro-ophta Eye Dressing S and D, Lohmann & Rauscher GmbH & Co. KG
  72. Information for syngo® Dynamics Version 6.0, Siemens
  73. Corrective action of BioMerieux for the AST-P533-Card
  74. Urgent Field Safety Notice for C7211, 5mmX45cm, Epix REUSABLE PROBE by Applied Medical…
  75. Corrective action for Troponin I-Check-1 device, VedaLab
  76. Safety Notice for Coulter® LH 750 and 780 Analyzer, Coulter® LH 500 Series System and…
  77. ArcRoyal Ltd.: Safety Notice for the BD Plastipak™ 50ml Luer Lok Syringes, which are part…
  78. Urgent Field Safety Notice for Philips IntelliVue Information Center iX by Philips Medical…
  79. Recall for Transseptal Sheath Introducer Kits, Thomas Medical Products Inc.
  80. Corrective action of Bayer for Advia 1200, Advia 1650 and Advia 2400 Systems
  81. Casters may break at Mobile Videocarts from Karl Storz
  82. Urgent field safety notice for ProcedurePak® trays containing Light Handle Cover (Devon™…
  83. Corrective action of the Position Acqisition Module from Boston Scientific
  84. Completed exchange of some artificial knees OP 4 from Medi
  85. Corrective Action for Genetic Screening Processor (GSP), PerkinElmer
  86. Transfer problems with VoxelQ-Workstations from Philips
  87. Lot Recall of the Cortex Screw Ø 4,5 mm, SYNTHES
  88. Urgent Field Safety Notice for ENDOTHERAPY PRODUCTS DUE TO THE INTEGRITY OF STERILE…
  89. Corrective action for Immunchemistry Systems C-Reactive Protein, Beckman Coulter
  90. Urgent field safety notice for multi-length ureteral stents, Bard Limited
  91. Recall Monosyn, Aesculap
  92. Recall for ITC60001 IMTEC ANA Screen and ITC70001 IMTEC ANA Screen (Cut-off), Human GmbH
  93. Recall for BBL Lowenstein-Jensen Medium Deeps, Becton Dickinson
  94. Urgent Safety Notice on PTA Balloon Dilatation Catheter product families (Models Coyote™…
  95. Urgent Field Safety Notice for Destiny Max and DT 100 by Tcoag Ireland Ltd
  96. Information about GE Healthcare Engström Carestations from GE Healthcare
  97. Safety Notice for Trophy IRIX 65, 70, 708, Novelix6510 and Oramatic 558, Carestream Health
  98. Safety Notice for the SD BIOLINE Malaria Ag products containing single-use buffer ampoule…
  99. Lot recall of Vanguard Open Box Femoral Components, Zimmer Biomet
  100. Failures of the Ipump Pain Management System from Baxter
  101. Safety Notice for syringe pump A600 S with Software 0.93 until 4.3X, Codan Argus
  102. Recall for NovaSure Radiofrequency Control Unit, Hologic Inc.
  103. Urgent Field Safety Notice for ENFit Universal Giving Sets, Fresenius Kabi
  104. Safety Notice for Switched Reusable Internal Defibrillation Paddles, Philips
  105. Recall for Dimension Vista ECREA Flex Reagent cartridges, Siemens
  106. Urgent Field Safety Notice for Percutaneous Thrombolytic Device (PTD) by ARROW…
  107. Recall Mach 1® Guide Catheter, Boston Scientific
  108. Recall of the 3,2mm Guide Pin Sleeve, Smith & Nephew Inc.
  109. Safety Notice for the AMPLATZER® Cardiac Plug, AGA Medical Corporation
  110. Safety Notice concerning the wheelchair models Vector, Tilty (II, Vario), Siro (II) and…
  111. Urgent field safety notice for RayStation 4.5 / 4.7 / 5 / 6, RaySearch Laboratories AB
  112. Follow-up Information for the Terumo® Advanced Perfusion System 1 - Heart-Lung Machine…
  113. Safety Notice for the MultiDiagnost Eleva, Philips Healthcare
  114. Recall Locking Screw, Stryker
  115. Recall for Reconstruction System Tenaculum instruments, Zimmer Inc.
  116. Corrective action for Calibrator Brahms Free βhCG Kryptor Cal, Brahms
  117. Recall of Dade Behring for EMIT Methothrexate Assay
  118. Additional Instruction for Use for the Edi catheter, Maquet Critical Care AB
  119. Lot recall of FOCUS FORCE intraocular lenses, Anadolu Tip Teknolojileri A.S.
  120. Urgent Safety Notice for alcohol prep pads co-packaged in Orbit Infusion Sets, ICU…
  121. Recall of all unexpired lots of „S.M.A.R.T. CONTROL“ Nitinol Stent System, Cordis
  122. Corrective action for Heartsine Samaritan AED
  123. Information concerning potentially defective screw fastenings for MOBILETT XP, MOBILETT XP…
  124. Recall Terumo® Weighed Flexible Sucker, Terumo
  125. Corrective action for software versions VA-15A of ACUSON S2000TM ultrasound systems
  126. Corrective action of Dade Behring for N-terminal Pro-Brain Natriuretic peptide
  127. Biotest recalls the tranfusion device TMSB-3
  128. Safety Notice for the pfm medical port systems, pfm medical ag
  129. Recall of C2 CryoBalloon Controller Cap, C2 Therapeutics Inc.
  130. Information concerning the Operating Microscope VM 900 from Möller-Wedel
  131. Urgent Field Safety Notice for Eleganza Krankenhausbett by Linet spol. S..o.
  132. Urgent Field Safety Notice for EndoBarrier by GI Dynamics Inc.
  133. Recall of the lot numbers 118532 and 118532A of Trypsik from Diasorin
  134. Corrective Action for the Abbott Molecular Bar Code Scanner User´s Guide, Abbott
  135. Recall of several lots of AGC DA 2000 Femoral Components, Biomet
  136. Urgent Field Safety Notice for Minisart by Sartorius Stedim Biotech GmbH
  137. 30mm Corrugated Tube in Ventiflow Breathing Circuits
  138. Carl Zeiss Meditec recalls the MEL 80 with CRS-Master and WASCA ANALYZER
  139. Urgent Field Safety Notice for Proteus 235/ProteusPLUS by IBA (Ion Beam Applications)
  140. Corrective action for Immulite 2000 IGF-1 of DPC Biermann
  141. Recall for Amerlex FT3, Trinity Biotech
  142. Safety Notice concerning a corrective action of the Giraffe and Panda Resuscitation…
  143. Recall for Berichrom PAI from Dade Behring
  144. Changes to Triathlon Mobile Bearing Knee Surgical Protocol, Stryker
  145. Urgent Field Safety Notice for Fitbone TAA by Wittenstein intens GmbH
  146. Field Safety Notice concerning adequate handling of PaxScan 4336R power cable, Varian…
  147. Safety Notice for the Odalys Screwholder, Kisco International
  148. Urgent field safety notice for several Hip, Knee and Shoulder products with high polished…
  149. Corrective action of the AED 10 and MRL Jumpstart defibrillators, WelchAllyn
  150. Urgent field safety notice for several Hip, Knee and Shoulder products with high polished…
  151. Recall for bone lever Verbruegge-Hohmann, MBP
  152. Urgent Recall of one lot of the product “Emser Inhalationslösung 20er”, Siemens & CO
  153. ViewPoint
  154. Quickels Systems AB has issued an information about a recall regarding certain Decapus II…
  155. Recall for Handi-Fil Disposable Syringe Fill Tube, Covidien
  156. Lot Recall for Skintact DF43N defibrillation electrodes, Leonard Lang Medizintechnik GmbH
  157. Urgent Field Safety Notice for Burr, Oval, 12 Flute, 5.5 mm x 13 cm by Arthrex INC
  158. PARI SINUS compressor (Type: 028)
  159. Corrective action of Beckman Coulter for stemCXP
  160. Medsorb Dominicana recalls the Ivalon Nasal Sponge
  161. i-STAT Level 2 Control
  162. Kerr recalls the adhesive system Optibond Solo Plus
  163. Recall for Vitros Chemistry Products DT Calibrator Kit, Ortho Clinical Diagnostics
  164. Urgent Safety Notice for the AOTI Hyper-Box System, AOTI Ltd.
  165. Urgent Safety Notice for NeuViz 16 CT system, Neusoft Medical
  166. Recall for BOWA electro surgical units ARC 300 and ARC 350, BOWA
  167. Korrekturmaßnahme für CYTO-STAT tetraCHROME, Beckman Coulter
  168. Recall for RELI SSO HLA typing kits, Invitrogen
  169. Baxter Prismaflex Sets, OXIRIS S - niverdused juurde- ja tagasivoolu vereliinides
  170. Corrective action for all IMPAX systems from Agfa
  171. Recall for Bondek Absorbable Suture, Teleflex Medical
  172. Recall for Accu-Chek Inform II meters, Roche
  173. Recall for Transseptal Guiding sheath, Baylis Medical
  174. Lot recall of Drehmomentschlüssel 10NM M.T-Griff, model number NE160R, Aesculap AG
  175. Expanded Recall concerning Vitrea Z-Axis Measurement Error on Vitrea software versions…
  176. Urgent Field Safety Notice for Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron…
  177. Urgent Field Safety Notice for DR 800 by Agfa HealthCare N.V.
  178. Advice for the Olympus LUS/LUS-2 Ultrasonic Lithotriptor
  179. Intuitive Surgical recalls the 8 mm EndoWrist Curved Scissor instrument
  180. Urgent Field Safety Notice for DOUBLE ROW FOOTPLATE, 180MM, TL-HEX STERILE & MEDIUM STRUT…
  181. Recall of Lead Cups used for capping of implantable Deep Brain Stimulation Leads (DBS)…
  182. Corrective action for Hexagon PSA, Human
  183. Lot recall of Medtronic / Covidien Devon Flexible Light Handle Cover, Medline…
  184. Recall of Creatinine PAP FS (Lot No.: 15317) due to deviating results, DiaSys
  185. Follow-up Notice for AED Plus Defibrillator, Zoll
  186. Corrective action for XPREZZON™ Bedside Monitor and qube™ Compact Monitor, Spacelabs…
  187. Urgent Field Safety Notice for BD Veritor Plus System Analyzer by Becton, Dickinson and…
  188. Urgent Safety Notice for the Edwards Commander Delivery System, Edwards Lifesciences LLC
  189. Philips Hemodynamic Application
  190. Lot recall for Calibrator A Kit on ADVIA Centaur® / XP and XPT Systems, Siemens Healthcare
  191. Three new warning statements in Instruction for Use for VCARE® Vaginal-Cervical…
  192. Possibility of probe heads on LOGIQ P6 Ultrasound Systems for heating up, GE Healthcare
  193. Lot recall of one Hydrofilm variant, Paul Hartmann AG
  194. Safety issue with 4D Planning procedure option of MultiPlan® Treatment Planning System…
  195. Recall for Misago® Peripheral Self-Expanding Stent Systems, Terumo
  196. Safety Notice for Tonometer Measuring Prisms, HAAG-STREIT AG
  197. Information of the correct connection breathing circuit tubes of AS3/ADU Anaesthesia…
  198. Urgent Field Safety Notice for Matoset by Torunskie Zaklady Materialów Opatrunkowych SA
  199. Recall for the Access HAV Ab Reagent, Beckman Coulter
  200. Batch recall of gauze swabs with x-ray thread, Karl Beese GmbH
  201. Low level current in CONTAK RENEWAL 3 RF and CONTAK RENEWAL 4 RF from Guidant
  202. Vliwaktiv Absorbent Activated Charcoal Dressing
  203. Information from the manufacturer Getinge Sterilization AB
  204. Urgent Field Safety Notice for Schiller Defibrillationselektrode by Leonhard Lang…
  205. Urgent Field Safety Notice for Fast-Cath Guiding Introducer Swartz S. Series by S.. Jude…
  206. Safety Notice for the device Glandomed Medizinische Mundspüllösung, CELL PHARM
  207. Urgent field safety notice for PTA dilatation catheter product families (Models Lutronix…
  208. Corrective action on Continuum MR Infusion Pumps from MEDRAD
  209. Recall for Total Knee 2100, Össur
  210. Advisory Notice of Medtronic for Implantable Neurostimulators Kinetra 7428
  211. Urgent Field Safety Notice for Algovita Spinal Cord System Stimulators Implantable (IPG)…
  212. Urgent Field Safety Notice for SONOLITH I-SYS by EDAP TMS France S.A.
  213. Exchange of the e-fix adapter standard Combi VII of the wheelchairs Handicare Emineo Care…
  214. Recall of all “Action 2000” manual wheelchairs of manufacturer Invacare Aquatec GmbH
  215. Urgent Field Safety Notice for Venovo Venous Stent System by Angiomed GmbH & Co…
  216. Recall for Dolomite Soprano rollator, Invacare
  217. Recall of several lots of RHK Femoral Components, Biomet
  218. Trulife informs about a recall of the Relax Xcell cushions
  219. Information for Impella XX Sets, Abiomed Europe GmbH
  220. Update to the global Field Corrective Action for the Standard Offset Cup Impactor…
  221. Software-Update for the product Aquarius iNtuition, TeraRecon, Inc.
  222. Urgent Field Safety Notice for Sinus-SuperFlex-635 by optimed Medizinische Instrumente…
  223. Upgrade Kits of Hemodiaysis Instruments from Baxter
  224. Safety Notice for the Product Compass 3.1 and 3.1a, IBA Dosimetry GmbH
  225. Urgent Field Safety Notice for Quantum Blue Anti-Infliximab by Bühlmann Laboratories AG
  226. Safety Notice for Therasphere Administration Set, MDS Nordion
  227. Safety Information for NobelClinician Software version 1.0.2, Nobel Biocare
  228. Recall for the Alcon® Small Volume Syringes 200μL Luer-Lok™, Alcon Laboratories (UK) Ltd.
  229. Recall of Acon Laboratories for the Quick-Chek Drug Screen
  230. PSI Kits
  231. C-Rad Catalyst (HD) süsteemid koos Elekta iCom või Varian ADI liidesega - tarkvarauuendus…
  232. Further Corrective Actions concerning Pari inhalers
  233. Safety Notice for APTUS Radius 2.5 Drill Block, Medartis AG
  234. Urgent field safety notice for Pak Lx Assay, lmmucor GTI Diagnostics Inc.
  235. Philips informs about a problem with Computer Tomography Scanners and Workstations
  236. Information about CareVue Chart Patient Data Management System, Philips
  237. Recall of plastic needles, Eckert & Ziegler BEBIG GmbH
  238. Filming problem with the Excelart and Vantage Magnet Resonance Imaging Systems from…
  239. Recall for GlucoHEXAL II Blutzuckerteststreifen, Gluco HEXAL II Starterset weiß and…
  240. Follow-Up / Safety Notice for the Puritan Bennett™ 980 Series Ventilator System, Covidien
  241. Revision of the instruction for use of TRICOS bone substitute from Baxter
  242. Lot Recall for OneTouch GlucoTouch Test Strips, Lifescan
  243. Corrective action V.E.Q. COAG A and B, Dade Behring
  244. Safety Notice for HomeChoice and HomeChoice PRO, Baxter Deutschland GmbH
  245. Lot Recall for Aequalis Fracture Stems, Tornier
  246. Corrective action for Immulite® and Immulite® 1000 Osteocalcin, Siemens
  247. Labelling correction of Hallu-C Plate, right, NEWDEAL
  248. Safety Notice for the Access 2 Systems, Beckman Coulter
  249. Stop of use for the products i-Visc ® 1.0, 1.4, 1.6 Sodium Hyaluronate and i-Visc ® 2.0…
  250. Recall of one batch number of the product i-Visc 1.0, i-Medical Ophthalmic International…
  251. Information for Brilliance CT Big Bore and CT Extended Brilliance Workspace, Philips…
  252. Safety Notice for GEMINI GXL and GEMINI TF Configurations, Philips
  253. Safety Notice for MultiDiagnost Eleva, UroDiagnost Eleva and OmniDiagnost Eleva Systems…
  254. Potential of wrong patient images when reviewing images on LOGIQ S8 Ultrasound System, GE…
  255. Safety Information for C.A.T.S Auto Transfusion System, Fresenius Kabi
  256. Urgent Field Safety Notice for RT-PLUS FEMORAL COMPONENT by Smith & Nephew Orthopaedics AG
  257. Recall for the Teleflex ISIS™ Tracheal Tubes with Subglottic Secretion Suction Port…
  258. Safety Notice concerning a corrective action of the equipment cart RIWOmobil, Richard Wolf…
  259. Safety Notice for GE Centricity RIS Software Versions, GE Healthcare
  260. Urgent Field Safety Notice for COULTER® EPICS® XLT Flow Cytometer with System II Software…
  261. Safety Notice for ACUSON and SONOLINE Antares and ACUSON S2000, Siemens
  262. Urgent Field Safety Notice for Vivid S60N, Vivid S70N, Vivid E80, E90, E95 by GE Vingmed…
  263. Urgent Field Safety Notice for Philips Intera, Achieva, Ingenia CX by PHILIPS HEALTHCARE…
  264. Urgent Field Safety Notice for Vivid iq, Vivid T8, Vivid T9 by GE Medical Systems (China)…
  265. Safety Notice for CT scanner Brilliance iCT, Philips
  266. Safety Notice for Allura Xper and Allura Integris X-ray systems, Philips
  267. Safety Notice for the Cadisc-L lumbar disc replacement, RANIER
  268. Infomation for BrainSCAN Treatment Planning Software, BrainLAB
  269. Urgent Field Safety Notice for GC80 by SAMSUNG ELECTRONICS Co., Ltd.
  270. Urgent Field Safety Notice for !M1 mobile x-ray by Solutions for tomorrow AB
  271. Safety Notice for specific green Toptex abdominal compresses, Lohmann & Rauscher
  272. Urgent Field Safety Notice for EPIQ Diagnostic Ultrasound System by Philips Medical…
  273. Urgent Field Safety Notice for Atellica IM and ADVIA Centaur fPSA Calibrator by Siemens…
  274. Urgent Field Safety Notice for FiberTak® DX Suture Anchor, Double-Loaded With 0.9 by…
  275. Advanced Bionics recalls the Implantable Cochlear Stimulators
  276. Follow-up Information for the AcrySof® CACHET® Phakic Lens, Alcon
  277. Safety Notice for GEMINI TF 16 and 64 Slice and GEMINI GXL 6 and 16 Slice PET/CT Systems…
  278. Urgent Field Safety Notice for Dexcom G6 CGM System by Dexcom, Inc
  279. Safety alert for Demipulse 103 and Demipulse Duo 104, Cyberonics
  280. Urgent Field Safety Notice for Carescape central unit by GE Medical Systems Information…
  281. Nipro recalls the SUREFUSER 100 ml system
  282. Corrective action for Olympus PK7200 Blood Grouping Systems, Beckman Coulter
  283. Safety Notice for Membrane Blue Syringes, DORC
  284. Corrective action and recall of Abbott for Cell-Dyn 4000
  285. Corrective action: VersaCell Connectivity with ADVA 1800 Systems, Siemens
  286. Information concerning Lifeline semiautomatic external defibrillator, model DDU-100 from…
  287. Important Information for Baxter peritoneal dialysis Transfer sets, Titanium adapters…
  288. Urgent Field Safety Notice by OHST Medizintechnik AG: Handling of fractured ceramic…
  289. Urgent Field Safety Notice for OmniDiagnost Eleva MultiDiagnost Eleva with Flat D by…
  290. Corrective action of Roche for the Linear Array Genotyping Test
  291. Recall of CEREFORM breast implants and sizers for regulatory reasons, Cereplas
  292. Urgent Field Safety Notice for SPY-PHI Drape by Stryker Endoscopy-San Jose
  293. CADD-Solis Li-ion Rechargeable Battery Packs
  294. Recall for Titan™ Stabilizer and Titan™ 360 Stabilizer, Terumo Cardiovascular Systems…
  295. Lot recall of Plastipak Syringe / Catheter tip with Luer slip adaptor, BD Medical MPS EEMA
  296. Urgent Field Safety Notice for AsperGenius Resistance Multiplex real-time PCR kit by…
  297. Safety Notice for Pitt-Easy Implant, SYBRON DENTAL SPECIALITIES, INC.
  298. Recall of the Endoscopic Ligating Clip Applier (ELC), ConMed
  299. Recall of multiple lots of Perthese and Mentor implants, Mentor
  300. Urgent field safety notice for VisuMax, Carl Zeiss Meditec AG
  301. Recall of Ball tip guide rods of the TriGen nail system, Smith & Nephew
  302. Recall of the Ringer DeltaSelect irrigation solutions from Delta Select
  303. Urgent Field Safety Notice for Nicolet EEG Wireless Amplifier by Natus Neurological…
  304. Recall of the products „ConMed Linvatec, Sterile, Ultra Power Burs, ConMed Linvatec E9000…
  305. Recall SmartCheck INR PSM analyzers and test strips, Unipath
  306. Safety Notice for analysers of CS-2x00i series because of erroneous results due to heparin…
  307. Safety Information for the bile and pancreas duct prosthesis, Mandel & Rupp Medizintechnik…
  308. Urgent Field Safety Notice for GRP-Handgriff by MGB Endoskopische Geräte GmbH Berlin
  309. Recall of the Mandrin/Stylets Introcan from B.Braun Melsungen
  310. Information for Eclipse Client 8.1.18 and DCF 8.1.17, Varian
  311. Safety Notice for Axiom Artis, Siemens
  312. Urgent Field Safety Notice for Soluscope Serie 4 by Soluscope S.A.S.
  313. Recall of Masstrak Immunosuppressants XE RUO Kit, Waters
  314. Urgent field safety notice for Biomesh Soft Prolaps / Soft Lift / Lift, Cousin Biotech
  315. Information for Futura Nova Junior, Merivaara
  316. Prosan informs on how to proceed if during removal of the IUD type Flexi-T 300 the IUD…
  317. Plus Othopedics recalls the compression screw XXS / XS compression Nail System
  318. Mölnlycke Health Care has issued an information about a manufacturing problem regarding…
  319. Recall for BacT/Alert FN Culture Bottle from Biomerieux
  320. Recall for the Immulite TNF-α Assay of DPC Biermann
  321. Corrective action for Architect Intact PTH Assay, Abbott
  322. Recall of Roche for Amplicor HPV Amplification Kit
  323. Lot Recall: Microlance 30 G Needles and Plastipak 1ml Syringe with Microlance 30 G Needle…
  324. Safety Notice for Liegebett klappbar, MTS Maschinenbau
  325. Urgent Field Safety Notice for Celsite Implantofix by B.BRAUN MEDICAL
  326. Safety Notice for the Invivo DynaCAD Breast Interventional Software Versions 3.1 and 3.2…
  327. Recall of transducers 8667 from B-K Medical
  328. Unomedical recalls the Microcuff Pediatric Endotracheal Tubes
  329. Safety Notice for MR ExamCard MobiFlex, Philips
  330. Corrective action for iSite PACS version 3.5, Philips
  331. Urgent Field Safety Notice for Dako Slide Racks by Dako North America, Inc.
  332. Missing directions for use at the Embolic Protection Systems and the Retrieval Sheaths…
  333. Recall for Fluitest CREA PAP, of Analyticon
  334. Urgent Safety Notice for the application of implantable spinal cord stimulation therapy…
  335. Safety Information on potential risk regarding device „Cholestech LDX ® Lipid Profile GLU…
  336. Safety Notice for the application of different models of implantable neurostimulation…
  337. Recall 4.0 cm Diameter Spherical Applicator, Carl Zeiss Meditec
  338. Corrective action for the ADVIA® Chemistry XPT System, Siemens Healthcare Diagnostics
  339. Recall Level Sensor II Pads, Terumo
  340. Recall for the Passeo-18 peripheral balloon catheter, BIOTRONIK AG
  341. Upgrade of Syramed µSP6000, Arcomed
  342. Recall for IMTEC CIC IgG Elisa, Human
  343. Urgent Field Safety Notice for Efficia CM10, CM12, CM100, CM120, CM150 by Philips Medical…
  344. Recall for PEP/RMT, Astra Tech
  345. Recall for XCaliber Meta-Diaphyseal Kit, Orthofix
  346. Information about suprapubic bladder catheter from Tyco Healthcare Deutschland
  347. Recall of all articles of cyclOS Putty, MATHYS European Orthopaedics
  348. Recall for ‘Tiefenmessgerät des MultiLoc Humerusnagelsystems’, Synthes
  349. Urgent Field Safety Notice for Xper Flex Cardio Physiomonitoring System by Philips Medical…
  350. Lot recall of cardiac guide wire, OptiMed Medizinische Instrumente GmbH
  351. Safety Notice for the product RayStation 2.0, 2.5, 3.0, 3.5 and 4.0, RaySearch
  352. Urgent Safety Notic for the FreeStyle® Blood Glucose Monitoring System, Abbott Diabetes…
  353. Urgent Safety Notice for the Invacare® Leo®, Invacare® Orion® & Invacare® Comet® Scooters…
  354. Urgent Field Safety Notice for Intraclude device by Edwards Lifesciences Utah
  355. Urgent Field Safety Notice for Ellipse ICDs by Abbott CRM
  356. Risk of infection or contamination with Medtronic Motor Option and Encoder Option devices
  357. Field Safety Notice concerning X-ray system Compax 40E from Philips Healthcare
  358. Recall for Monitor Tables on the Galileo, Immucor
  359. Recall for Mölnlycke Procedure Pak, Mölnlycke Health Care
  360. Recommendation for Servo-i ventilators from Maquet
  361. Urgent Field Safety Notice for Paratherm, Heater/Cooler by Chalice Medical Ltd.
  362. Information for the Harrison Fetal Bladder Stent Sets from COOK
  363. Information concerning the prematurely battery depletion of the Lifepak CR Plus and…
  364. Field Safety Notice for Elekta Motorized Wedges be used with Dynamic Conformal XiO®…
  365. Urgent Field Safety Notice for Verso Shoulder Humeral Shells and Verso Shoulder Stemmed…
  366. Urgent Field Safety Notice for DynaMesh-IPST by FEG Textiltechnik Forschung- und…
  367. Easycare Research recalls the heat and moisture exchanger
  368. Recall of Ligament Staples from the company Arthrex
  369. Important Safety Notice concerning Oxylog 2000 plus and Oxylog 3000 plus ventilators…
  370. Safety Notice for BD Plastipak 50 ml Luer Lok syringes included in several Procedure…
  371. Urgent Field Safety Notice for DELFIA Xpress PlGF Kit (Placental Growth Factor) by…
  372. Baxter recalls the Intermate Filling Set
  373. Recall for MRS-Cemented Stems, Stryker
  374. Safety Notice and Recall for Epicardial Lead Models, Medtronic
  375. Urgent Field Safety Notice for Accu-Chek Inform II Base Units (BU) and Handheld Base Units…
  376. Urgent Field Safety Notice for Bipolar Head Bionit2, Mathys Ltd. Bettlach
  377. Urgent Field Safety Notice for Absaug-, S.ül- oder Drainageschlauch by Silikon-Technik…
  378. cefd8917-178d-893b-894a-7fd95fc9f5a8
  379. Information for ADVIA Chemistry Systeme, Siemens
  380. Safety Notice for the device Clear-Flex bag with Emoluer valve, Baxter
  381. Incorrect Instructions for Use with the Model 93600 of the Closed Injectate Delivery…
  382. Recall for InterTan Entry Portal Handle, Smith and Nephew
  383. ARROW recalls the Over-The-Wire PTD
  384. Information for dialyzer Dialog, B. Braun
  385. Safety Information for the DALI LDL apheresis therapy, Fresenius
  386. Safety Corrective Action for the Hemofiltration Device AQUARIUS (regular platform 6)…
  387. Information concerning Lifepak CR Plus from Medtronic
  388. Lot Recall for PEG Verbandset Standard, Dolp Medical
  389. Incorrect position readout values caused by excessive connector resistance of C-Series…
  390. Corrective Action for Coulter LH 500 Analyzer, Coulter LH 750 Analyzer, Coulter LH 780…
  391. Batch recall of SUSI Instruments because of potential insterility, Aesculap AG
  392. Urgent Field Safety Notice for Centricity Universal Viewer by GE HEALTHCARE INTEGRATED IT…
  393. Urgent Safety Notice for the RetCam Ophthalmic Imaging System with software versions…
  394. Recall Factor V Leiden Kit, Roche
  395. Urgent Field Safety Notice for CareLink Programmer; CareLink Encore Programmer by…
  396. Recall of the Clearview Simplify D-Dimer from Unipath
  397. Information for AU2700 Clinical Chemistry Analyser, Olympus
  398. Urgent Safety Notice for the computer-assisted surgical device ROSA™, Medtech
  399. Information about Intera 1.5 T Systems from Philips
  400. Lot recall of devices for BioFoam Surgical Matrix, CRYOLIFE
  401. Urgent Field Safety Notice for Celex and Intelli-C EU by NRT-Nordisk Røntgen Teknik A/S
  402. Lot recall of AMT Bridle - Nasal Tube Retaining System, Applied Medical Technology Inc. /…
  403. Recall of the IMHS CP Lag Screw Insertion Wrench from Smith & Nephew
  404. Recall of Shoulder Suspension Tower, Arthrex / Allen Medical Systems / Hill-Rom SAS
  405. Corrective action of ORTHOPHOS XG Plus and XG 5 from Sirona
  406. Urgent field safety notice for DR system GU60A, Samsung Electronics
  407. Urgent Field Safety Notice for Selenia Dimensions by Hologic, Inc Marlborough
  408. Urgent Field Safety Notice for SQUID / SQUIDPERI by EMBO-FLÜSSIGKEITEN A.G.
  409. Bio-Rad IH-Com Kit - admin profiili kasutamine tavatoiminguteks aeglustab seadme tööd
  410. Urgent Safety Notice / Recall for IS-Can CO2-Absorber, Intersurgical
  411. Urgent Field Safety Notice for Instrument Tray, Basic T2 Femur Long by Stryker Trauma Kiel
  412. Urgent Field Safety Notice for NavitrackER Markers by Zimmer CAS
  413. Corrective action of the computed tomography systems Brilliance from Philips
  414. Recall of Biomerieux for Slidex Strepto-Kit, Slidex Strepto B and Slidex Strepto D
  415. Expanded Safety Notice for the PentaRay NAV catheters, Biosense Webster / Johnson &…
  416. Safety Notice for JiveX, VISUS Technology Transfer GmbH
  417. Recall for Access Progesterone Reagent Kit and Access Cortisol Reagent Kit, Beckman…
  418. Safety Notice for RT Chart, a function of ARIA™, Varian medical systems
  419. Recall for Trigen Trochanteric Nail, Smith & Nephew
  420. Urgent Safety Notice for BD Microlance 30G Needles / Cataract Set, ArcRoyal Ltd.
  421. Recall for Easypump ST 100-1, I-Flow
  422. Urgent Field Safety Notice for Parietex Composite Mesh Polyester with Absorbable by…
  423. Corrective action for Pentra 120, Pentra 120 retic, Pentra DX 120 and Pentra DF 120, Axon…
  424. Safety Notice for Defibrillator FRED easy, Schiller
  425. Safety Notice for the 8V3c transducer on the ACUSON SC2000 ultrasound system, Siemens
  426. Urgent Field Safety Notice for Philips PageWriter TC Cardiographs (TC20/30/50/70) by…
  427. Urgent Field Safety Notice for INVOS reusable sensor cable for PM7100 / INVOS Reusable…
  428. Urgent Field Safety Notice for QMS Tacrolimus Immunoassay Calibrator kit by Microgenics…
  429. Corrective action from Olympus for Glucose OSR 6X21 and Glucose STAT OSR6140
  430. Corrective action of Dade Behring for the MicroScan LabPro Software
  431. Recall and corrective action for OneTouch® GlucoTouch® blood glucose analyzers, Lifescan
  432. Safety Notice for Avantgarde Back Tube, Otto Bock
  433. Field Safety Notice for EM2400 Exacta-Mix Compounder, Baxa
  434. Recall of Roche for Stago PTT-LA
  435. Recall for the Dimension clinical chemistry system Cardiac Troponin-I of Dade Behring
  436. Recall for AB 5000 Console, ABIOMED
  437. Recall for the FOCUS Gesundheit Kinderwunsch-Test, ulti med Products (Deutschland) GmbH
  438. Safety Information for the Incubator Platforms P1, Hissin Medizintechnik GmbH
  439. Malfunction in the using of the OR table of the MAGNETOM Espree System from Siemens
  440. Recall for XLD Medium, Oxoid
  441. Urgent Field Safety Notice for GOT (AST) mod. IFCC; GPT (ALT) mod. IFCC by DIALAB GmbH
  442. Biomet Cementing Technologies recalls the Plug Inserter
  443. Lot recall of STA-Cuvettes, Diagnostica Stago
  444. Problem with Axiom Artis system VB11D or VB20B software from Siemens
  445. Recall Suture Material, Aesculap
  446. Urgent Safety Notice for the Liquid Urine Control Level 2, Randox Laboratories Ltd.
  447. Urgent Field Safety Notice for FLOW REGULATOR SET by Baxter Healthcare S. (Opfikon)
  448. Recall MixMate, Eppendorf
  449. Recall of Becton Dickinson for BD FacsCantoTM Flow cytometer
  450. Information for Omega IV and Omega V tables, GE Healthcare
  451. Urgent Field Safety Notice for PROSET MULTIPACK SYRINGES by B. Braun Melsungen AG
  452. Ciba Vision recalls FreshLook Radiance Moonlight soft contact lenses
  453. Corrective action and recall for Ortho AutoVue and AutoVue Ultra
  454. Information concerning the ICARE intraocular lense from Corneal
  455. Information for TomoTherapy Hi-Art System, TomoTherapy
  456. Safety Notice for Hamilton-G5 and Hamilton-S1 ventilators, Hamilton Medical
  457. Corrective action for Proteus XR/a X-ray imaging systems, GE Healthcare
  458. Batch recall for Endobon Xenograft Granules, Biomet France SARL / BIOMET 3i Deutschland…
  459. Lot recall of Devon™ Light Gloves, Medtronic GmbH
  460. Urgent Field Safety Notice for Infusomat Space Line Type Transfusion by B. Braun Melsungen…
  461. Corrective action of the Glucose Systems 201 from Hemocue
  462. Urgent field safety notice for Cholinesterase 981370, Thermo Fisher Scientific Oy
  463. Intersurgical Complete Respiratory Systems recalls adult circle breathing systems
  464. Safety Notice for MultiDiagnost Eleva FD X-ray system, Philips
  465. Exchange of the chassis connecting rod at the Gemini lifters from Mebido
  466. Safety Notice and Software upgrade for model 8870 application card, Medtronic
  467. Recall for chronOS Putty, MATHYS
  468. Urgent Safety Notice for several Invacare Concentrators, Invacare GmbH
  469. Recall of IBS II spreaders PT 6 mm / 8 mm / 10 mm and IBS II spreaders O 6 mm / 8 mm…
  470. Laerdal Medical recalls an adaptor cable
  471. Information for Ambulift/Multilift, ArjoHuntleigh Ltd.
  472. Safety Information for the surgical systems da Vinci S, da Vinci Si and da Vinci Si-e…
  473. Information about Miroclav and System 1000 from Baxter
  474. Field Safety Notice about a problem when using m3 micro-Multileaf-Collimator (mMLC)
  475. Lot Recall for the Biosure-HA Interference Screw, SMITH&NEPHEW
  476. Failure of a special population of roller pumps for Arterial pumps from TERUMO
  477. Replacement kits for wheelchairs Rea 705 Silencio-Care, Invacare
  478. Recall Medfusion Syringe Infusion Pump, Smiths Medical
  479. Recall of Codman ICP Skull Bolt Kit, Codman
  480. Urgent Field Safety Notice for Cannulated Drill for Metacarpal III, Large by Swemac…
  481. Corrective action for cobas c-pack MULTI, Roche
  482. Safety Notice concerning a corrective action of the electrophysiology (EP) system Carto 3…
  483. Recall for Human sTfR Quantikine IVD Elisa, R&D Systems
  484. Software Upgrade for Fraxel re:store DUAL Laser Systems, Solta Medical
  485. Urgent Field Safety Notice for Aurinio LED OP Leuchte by Trilux Medical GmbH & Co. KG
  486. Lot Recall for the Accu-Chek FlexLink Plus infusions sets, Roche Diabetes Care
  487. Safety Notice for MultiDiagnost Eleva II R.6.1.1, Philips
  488. Corrective action of Lifescan for OneTouch Ultra, EuroFlash and InDuo blood glucometers
  489. Safety Notice concerning Evita Infinity V500, Babylog VN500 and Evita V300 ventilators…
  490. Urgent Field Safety Notice for ProSet Intrafix SafeSet by B. Braun Melsungen AG

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