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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 Discovery VCT, RX VCT, STE, RX and ST PET/CT systems with Dimension…
  2. Lot Recall for the Original-Perfusor® syringe 50 ml with cannula, B. Braun Melsungen
  3. Urgent Field Safety Notice for Niederdruckschlauch, CO2, 150 cm by Karl Storz S. & Co KG
  4. Safety Notice concerning possible configuration issue on RapidArc and VVMAT systems…
  5. Recall for Hydromax, Carl Zeiss Meditec
  6. Urgent Field Safety Notice for Echinococcus IgG ELISA by IBL International GmbH
  7. Urgent field safety notice for LIAISON Control Borrelia IgM Quant / Borrelia IgM II…
  8. Urgent Field Safety Notice for Direct Bilirubin and Total Bilirubin Assays by Siemens…
  9. Recall of the products „ML Taper Offset Rasp Handle“ from Zimmer Inc., USA
  10. Urgent Field Safety Notice for Alinity hq Analyzer by Abbott GmbH & Co. KG
  11. Life-span of accumulators for infusion pumps from Fresenius
  12. Urgent Field Safety Notice for ALLUX by Nabtesco Corporation
  13. Cardiac Science recalls the Powerheart AED model 9200RD und 9212RD
  14. Corrective action for the Ortho Mitis 2 Sample Processor from Ortho
  15. Safety Notice for Focal Treatment Planning Software, CMS Software
  16. Lot Recall for PALAMIX single use vacuum mixing and application systems, Heraeus Medical…
  17. Safety Notice for Apheresis Bowl 0625B-00, Haemonetics
  18. Urgent Field Safety Notice for Dopplex by Huntleigh Healthcare Ltd. Diagnostics
  19. Recall of Brahms PCT-Q from Brahms
  20. Philips Medical Systems Nederland BV Philips Azurion, Philips Allura -l-kaare pöördkate…
  21. Exchange of upper tubes with handle in walking aid Quadruped, Swereco Rehab AB
  22. Recall of VariSource™ IX and 200 series Nucletron Adapter and Transfer Guide Tube and Set…
  23. Refitting of Spacelabs Medical Capnography Module model 91517, Spacelabs Healthcare
  24. BacT/ALERT 3 D combination modules
  25. Updated Instructions for Use for Thermablate Endometrial Ablation System (EAS), Idoman…
  26. Urgent Field Safety Notice for INTRAPUR NEONAT I.V.FILTER 0.2MICRON by B. Braun Melsungen…
  27. Corrective Action/Recall for BRAHMS fβhCG KRYPTOR, Brahms
  28. Lot recall of ROTEM platelet cuvettes, Tem Innovations GmbH
  29. Recall of Roche for Elecsys Assay Tips
  30. Safety Notice for Thermablate EAS, Aspide Médical GmbH
  31. Recall of Axon Lab for Arkray Kenshin II Multiteststrips for determination of HDL-C
  32. Beckman Coulter recalls sample cups
  33. Lot recall of m-IBG (code N.60), GE Healthcare Buchler GmbH & Co. KG
  34. Advisory Notice from Smith & Nephew for Macrotetured Profix and Genesis II femoral…
  35. Recall of DakoCytomation for HercepTest
  36. Safety Notice for CoaguChek XS and CoaguChek XS Plus Systems, Roche
  37. Recall for Isobar TTL-Module In polyaxial screws, SCIENT’X
  38. Lot Recall for Everest Inflation Device / Survival Kit, Medtronic
  39. Safety Notice for Ultimate Endo Retrieval Pouch, Cory Bros
  40. Safety Notice concerning Brilliance 64 and Ingenuity CT with Software Version 3.5.1…
  41. Recall of St. Jude Medical ICD Photon, Photon Micro and Atlas
  42. Field Safety Notification concerning the Synchromed EL pump motor from Medtronic
  43. Recall of the BD Procount Kit (lot number 45602) from Becton Dickinson
  44. Recall for Skin-Bond, SAUER CONTINENCE
  45. Urgent field safety notice for OXYWAY pressure reducer for Fast and Click types, WEINMANN…
  46. GE Healthcare EKG kaablid ja juhtmed – võimalik energia vähenemine defibrillatsiooni ajal
  47. Safety Notice for LeVeen™Needle Electrodes, Boston Scientific
  48. Information for the use of the Hemoglide™ Catheter Kits from BARD Access Systems
  49. Urgent Field Safety Notice for Reaxon Direct by Medovent GmbH
  50. Recall for Genesis II Primär LS Führung I/M, Smith & Nephew Orthopaedics
  51. Urgent Field Safety Notice for BMV Filterkassette highflow/TRACHEOCUR HME Cassette…
  52. Safety Notice for the Giraffe In Bed Scale, GE Healthcare
  53. Recall for DAT IgG-Dilution ID-Card, BioRad/DiaMed GmbH
  54. Urgent Field Safety Notice for CRP FS by DiaSys Diagnostic Systems GmbH
  55. Recall for LightCycler EBV Quant Kit, Roche
  56. Urgent Field Safety Notice for Alinity i,c Processing Modules, Alinity s system by Abbott…
  57. Recall for LightCycler VZV Qual Kit, Roche
  58. Urgent Safety Notice for the INfusor, FOLfusor and Intermate products, Baxter
  59. Recall for Twin-Pass® Dual Access Catheter, Vascular Solutions
  60. Information about PEG devices from Pfrimmer Nutricia Healthcare
  61. Safety Information for Ceragem-E, Ceragem Europe GmbH
  62. Recall of the 6 F Guider Softip™ XF Guide Catheter from Boston Scientific
  63. Urgent Field Safety Notice for Idylla EGFR Mutation Test by Biocartis
  64. Recall for HemaCarotid Patch ultrathin knitted, InterVascular S.A.S.
  65. Safety Notice for EEG recorder NicoletOne® System, CareFusion
  66. Urgent Field Safety Notice for PARI LC SPRINT Tracheo by PARI GmbH
  67. Recall for Disposable Scope Warmer, Stryker
  68. Information for the ophthalmologic examination unit Doms Concentric from Doms…
  69. Malfunction of the LIFEPAK® 20 defibrillators/monitors from Medtronic
  70. Urgent Safety Notice for Varian High Energy Clinacs® and TrueBeam™ Systems, Varian medical…
  71. Lot recall of ELISI0-19H, Nipro Europe NV
  72. Safety Notice for AV-Set Dialog, B. Braun
  73. Recall of intraocular lenses from Advanced Medical Optics
  74. OptiMed recalls its "sinus-Carotid-RX-Systems". It was reported that the stent was…
  75. Urgent Field Safety Notice for TECHNOZYM ADAMTS13 Activity ELISA by Technoclone GmbH
  76. Recall for IMTEC-ANA-LIA, Human
  77. Recall for BD Venflon™ Pro Safety Peripheral IV Catheter, Becton Dickinson
  78. Corrective Action for APO A1 and B Calibrator, Beckman Coulter
  79. HeartStart XL+ Defibrillator/Monitor
  80. Recall/Corrective Action of Beckman Coulter for Estrone RIA kit, Beckman Coulter
  81. Urgent Field Safety Notice for r ex-tem Reagenz by Tem Innovations GmbH
  82. Zimmer recalls Optan Stem
  83. Recall for APEX 2.0, APEX 2.1, APEX 2.2 software on Hologic Bone Densitometers, Hologic…
  84. Lot Recall for suction catheters with funnel connectors, Unomedical
  85. Urgent Safety Information for the Cios Alpha System, Siemens Healthcare
  86. Recall of the Cryocyte 500 ml freezing bag from Baxter
  87. Extension of the recall of certain lots of the Mach I™ Guide Catheters from Boston…
  88. Recall for MDI Hybrid Implants with O-Ball Abutment, IMTEC
  89. Lot Recall of a heart-lung bypass set intended for extracorporeal oxygenation, Maquet
  90. Recall for AUF Stent Graft TM, Vascular Innovation
  91. Safety Notice for Forefoot Cannulated Drill Sterile, Newdeal
  92. Blood Collection Systems and Filters
  93. Purified silicon oil reference S5.7570, S5.7170, S5.7560 et S5.7160
  94. Recall for Stratus CS Acute Care Troponin I TestPak, Siemens
  95. Lot Recall for Codman Surgical Patties, Codman
  96. Safety Notice concerning implementing a colour code for all thermosept / thermodent…
  97. AK 98
  98. Recall of Ortho Clinical Diagnostics for Vitros Immunodiagnostic Products
  99. Information zu Wilson Spinal Column Support, Trumpf
  100. Safety Notice/Update for the Ysio Max and Ysio Systems, Siemens Healthcare
  101. Follow-up Information concerning the Camino® ICP-Monitor and Licox® PtO2-Monitor, Integra…
  102. Corrective action and recall for GEM Premier 4000 - K+ Reporting, Instrumentation…
  103. Urgent Field Safety Notice for MultiPulse HoPLUS by Asclepion Laser Technologies GmbH
  104. Recall for VERSAFITCUP, Medacta
  105. Urgent field safety notice for Etermis 2, Merz Pharmaceuticals GmbH
  106. Recall for ADVIA Chemistry Systems, Siemens
  107. Recall for ORTHOPILOT DISPOS. PASSIVE MARKER STERILE, Aesculap
  108. Urgent Field Safety Notice for Radiometer ABL800 by Radiometer Medical ApS
  109. Safety Notice for Bright View Gamma Camera, Philips
  110. Exchange of the battery box cover in patient hoists from aks
  111. Safety Notice for Ionized Calcium and Ionized Magnesium Sensors, Nova Biomedical
  112. Urgent Field Safety Notice for Medumat Transport by WEINMANN Emergency Medical Technology…
  113. UnoMedical recalls the Steriseal 27G Peribulbar cannula
  114. Recall for BBL™ Staphyloslide™ Latex Test Kit, Becton Dickinson
  115. Recall for the products STERRAD Cycle Sure 24 Biological Indicator, Validation Kit and…
  116. Urgent Field Safety Notice for ORTHO VISION Max BioVue Analyser by Ortho Clinical…
  117. Recall for LIFECODES Pak2-LE, GEN-PROBE
  118. Corrective action - Manufacturer IFU replacement for the VariLase® Endovenous Laser Fibers…
  119. Urgent Field Safety Notice for EliA Ro Well by Phadia AB
  120. Urgent Field Safety Notice for PHIL - Liquid Embolic by MicroVention Europe
  121. Safety Notice for Zeus Infinity Empowered units, Dräger
  122. Lot Recall for ARCHITECT STAT Troponin-I, Abbott
  123. Recall of the Crossfire Console, Stryker
  124. Corrective action for the Strep A Schnelltest-Streifen and the Strep A Schnelltest-Gerät…
  125. Recall for ABX Eosinofix, Horiba ABX SAS
  126. Safety Notice for the LANTIS™ OIS system, Siemens
  127. Recall for LIFECODES Pak12G, GEN-PROBE
  128. Corrective action for the Oxoid Antimicrobial Susceptibility Testing Disc P1 Penicillin G…
  129. Information about the birthing beds Affinity P 3700 from Hill Rom
  130. Corrective action for the rapid AST testing by means of the Micronaut-SB product line of…
  131. Recall for LIFECODES QuikScreen QS12G, GEN-PROBE
  132. Batch recall of Stainless steel head Ø22 Medium Neck, Evolutis
  133. Recall of electrode belts of the LifeVest-Systems WCD 3000 of ZOLL Lifecor Corporation
  134. Corrective action from Roche for Total Bilirubin Granulat
  135. Recall for PDS Cord, PDS Cord II and Ethipin bone pins, Johnson & Johnson Medical
  136. Lot recall of CELL-DYN Emerald Cleaner, Abbott Laboratories
  137. Smith Medical recalls the Pencil Point Spinal Needle and Lancet Tip Spinal Needle…
  138. Urgent Field Safety Notice for A.V. Fistula Sets for Hemodialysis, KAWASUMI LABORATORIES…
  139. Urgent Field Safety Notice for Carescape R860 by GE Healthcare Technologies (Datex Ohmeda)
  140. Recall for KadeFungin Milchsäurekur, Dr. Kade
  141. Urgent Field Safety Notice : Patient egress issue associated with MRI systems, GE…
  142. Safety Notice for the READY View application software, GE Healthcare
  143. Urgent Field Safety Notice for Alinity hq Analyzer and Alinity hs Slide Maker Stainer…
  144. Recall of disposable Compact Absorbers used with GE Healthcare anaesthesia systems
  145. Recall for infusion pump administration sets for use with Curlin ambulatory infusion…
  146. Corrective action of Beckman Coulter for Synchron Systems Lipase Reagent
  147. Recall of the Coaguchek XS meters from Roche
  148. Urgent Field Safety Notice for Stereotacticradiotherapy/MRI System by ViewRay Inc.
  149. Microlance Hypodermic Needle, sterile
  150. Corrective action of Becton Dickinson for BD Phoenix ID/AST Panels
  151. Recall of the Respiratory Monitors Nico Model 7300 from Respironics
  152. Urgent Field Safety Notice for Medilas H140 by Dornier MedTech Systems GmbH
  153. Recall of One Touch Ultra 2 blood glucose analyzers from Lifescan
  154. Corrective action/Recall for Galileo Instrument, IMMUCOR
  155. Urgent field safety notice for AutoSPECT Pro on: IntelliSpace Portal software versions 5.0…
  156. Recall for Portex® Blue Line Ultra Tracheostomy Kit, Smiths Medical
  157. Urgent Field Safety Notice for HeartMate 3 Coring Tool by Thoratec Corporation
  158. Urgent Field Safety Notice for PIPELINE FLEX W/SHIELD TECHNOLOGY by Micro Therapeutics…
  159. Information for Contour Blood Glucose Monitoring Systems, Bayer
  160. Urgent Safety Notice for the Kenex suspension arm with radiation shield and/or surgical…
  161. Safety Notice for the product Nasobiliary drainage catheter, PRINCE MEDICAL
  162. Urgent Field Safety Notice for Versatex Monofilament Mesh 50 x 50 cm by Sofradim
  163. Information about CELL-DYN Sapphire™ (article number 8H00-01) and measures by Abbott
  164. Corrective action for Cobas b 221, Roche
  165. Lot recall of sterile endoprosthetics products and cancellous screw VariaCup, aap…
  166. Recall for Cypher Select® + Sirolimus-eluting Coronary Stents, Cordis
  167. Urgent field safety notice for atraumatic compact Cysto-Urethroscope 25°, Richard Wolf…
  168. Field Correction Notice for all e360 ventilators, Newport Medical
  169. Urgent field safety notice for M. HINTON 2 SHEEP BLOOD 90 20PL- (Ref. 43321), bioMérieux…
  170. Urgent Field Safety Notice for Servona Silver Cannulas (REF various) by Servona GmbH
  171. Boston Scientific Ingenio, Accolade Family Pacemakers - kiirenenud akude tühjenemine
  172. Flocare® Safety+ GT /-Suction
  173. Recall for proCART trephines, Aesculap
  174. Corrective action for Dimension Vista System, Siemens
  175. Recall for INNOTEST hPLAP, INNOGENETICS
  176. Corrective action of Roche for Stago STA Compact and STA Compact CT analyzers
  177. Information for SERVO-i, Maquet
  178. Safety Notice for Monosyn Violet 3/0 (2) 70 CM HR26 (M), Braun Surgical
  179. Safety Notice for the PARACHUTE Delivery System, CardioKinetix Inc.
  180. Urgent Field Safety Notice for Radiometer ABL800 FLEX by Radiometer Medical ApS
  181. Recall for Stryker PainPump Catheters, Stryker GmbH
  182. Recall of certain lots of the Trinity Biolox Delta liner and Corin Biolox Delta modular…
  183. Urgent Safety Notice for Covidien Devon™ Light Glove in KitPack® OP-Setsystems, Lohmann &…
  184. Recall for dual Lumen Catheter, Gyrus ACMI Inc.
  185. Urgent Field Safety Notice for DracoFoam (Infekt haft oder haft sensitiv) by Dr. Ausbüttel…
  186. Recall for Wallaby III Tibial insert C-18 and B-18, constrained, Zimmer
  187. Safety Notice for MammoDiagnost DR, Philips Healthcare
  188. Field safety notice for intraocular lenses CT ASPHINA 404V and CT ASPHINA 409MV, Carl…
  189. Safety Notice for VNS Therapy Model 250 Programming System, Cyberonics
  190. Urgent field safety notice for ARCHITECT Estradiol Reagent / list number (LN) 7K72, Abbott…
  191. Safety Notice for GCX Euro Rail Clamp, Dräger Medical
  192. Information about a potential risk concerning several Nasal Aspirators from GE Healthcare
  193. Urgent field safety notice for AutoSPECT Pro on Extended Brilliance Workspace NM software…
  194. Urgent field safety notice for HIGH / MID PROFILE single compartment cushion with Sensor…
  195. Safety Notice for Savanah Bath Seats manufactured by Patterson Medical Ltd., RUSSKA
  196. Expanded Recall for the Occlusion Catheters, Teleflex Medical GmbH
  197. Urgent field safety notice for Homepump C-Series with DEHP-free tubing, Halyard Health…
  198. Urgent Field Safety Notice for iChemVELOCITY Urine Chemistry Strips by Beckman Coulter…
  199. Urgent Field Safety Notice for Duet External Drainage and Monitoring System; Duet External…
  200. Corrective action and recall of the MicroScan LabPro Information Manager System (software…
  201. Information about FC 500 with CXP Software, FC 500 MPL with MXP Software and CXP Analysis…
  202. Safety Notice for syngo® RT Therapist 4.2 & syngo® RT Oncologist 4.2, Siemens Healthcare
  203. Urgent Safety Notice for Birdie Lifters, Invacare
  204. Corrective action of Olympus System Reagent Cholesterol and HDL Cholesterol, Olympus
  205. Corrective Action/Recall for ARCHITECT AFP, Abbott
  206. Recall for the Solus Anterior Lumbar Interbody Fusion Spinal Spacer System, ALPHATEC SPINE
  207. Urgent field safety notice for Robot Imager and Gantry Imager, Siemens Healthcare GmbH
  208. Recall for Universal-Set Landshut, Mölnlycke
  209. Corrective Action for EasyLink Informatics System, Siemens Healthcare
  210. Urgent Safety Notice for the Allura X-ray systems, Philips Healthcare
  211. Recall of Marrow-Cut Biopsy Needles from Somatex Medical Technologies
  212. Safety Information for the Infusion pump CODAN ARGUS 717/718V, control software version…
  213. Urgent Field Safety Notice for Mölnlycke® Procedure Trays by Mölnlycke Health Care AB
  214. Recall for METASUL Heads, Zimmer
  215. Recall for Factor V Leiden Kit, Roche
  216. Accutrend Glucose test strips in falsified packages, Roche
  217. Recall and after-care recommendation for WATCHMAN FLX Left Atrial Appendage (LAAC) Closure…
  218. Urgent Field Safety Notice for Ammonia Flex reagent cartridge by Siemens Healthcare…
  219. Incorrect pictures with the Centricity Carddas IMS AI 1000 workstation from GE Healthcare…
  220. Mandatory ugrade on all VISX™ WaveScan WaveFront™ Systems from Advanced Medical Optics
  221. Urgent field safety notice for Aisys family of anesthesia devices, GE Healthcare
  222. Recall of the products TOM PLUG FOR 01-15400/401 from Stryker
  223. Problems with Magnetic Resonance Tomography systems from Hitachi
  224. Urgent Field Safety Notice for Dimension Vista Analysensystem by Siemens Healthcare…
  225. Disconnection of the internal oxygen hose connexion inside the Datex-Ohmeda S/5 Aespire…
  226. Recall of the Winged Infusion Set Implantable Vascular Access System from Arrow…
  227. Urgent Safety Notice for Users of e.cam and all Symbia systems with foresight detectors…
  228. Urgent Field Safety Notice for FilmArray Gastrointestinal (GI) Panel by BioFire…
  229. Correct handling of the Talon™ and Symmetry™ Angioplasty Balloon Dilatation Catheters
  230. Recalls of the iLA interventional Lung Assist Membrane Ventilator from NovaLung
  231. Urgent Recall of certain Tobii C-Series batteries, Tobii Technology AB
  232. Recall of lntegra 3 micromanipulator, Research Instruments Limited
  233. Nephros recalls the OLpur MD 190
  234. Lot recall of ERGO handle, Erbe Elektromedizin GmbH
  235. Corrective action for Access Ostase Calibrators and Access Ostase QC, Beckman Coulter
  236. Corrective Action for HSV1/2-050, Diagenode
  237. Corrective action for Dimension Vista® Thyroid Stimulating Hormone (TSH), Siemens…
  238. Possible potential interference of Methylene Blue and other vascular dyes with readings on…
  239. Urgent field safety notice for IONTRIS (10013850 und 10013851, Siemens AG), Siemens…
  240. Lot recall of Fetch 2 Aspiration Catheter, Boston Scientific International S.A.
  241. Urgent Field Safety Notice for eCLIPs Bifurcation Remodelling System by Evasc Medical…
  242. Lot Recall of the Silicone CTS ® (Close to Shaft) Cuff Adjustable Neck Flange Tracheostomy…
  243. Safety Notice for the product QLAB 10.0 von Philips Ultrasound (auf Xcelera), Philips…
  244. Safety Notice for Affinity Four Birthing Bed, Hill-Rom Inc.
  245. Braun Aesculap recalls Targon tibia nails KCC464S
  246. Corrective action of Dade Behring for Berichrom AI III (A) Kits OWWR
  247. Safety risk of Artiste™ digital linear accelerators with syngo® RT Therapist Version 4.1…
  248. Corrective measures concerning the NIM EMG Endotracheal tubes from Medtronic
  249. Information for Life Scope P BSM-4100K and Life Scope A BSM-5100K, NIHON KOHDEN
  250. Information for UniCel Dxl 600 and 800 Systems Software Version 4.3
  251. Safety Information for aks-foldy and aks-torneo, Aks GmbH
  252. Urgent Field Safety Notice for ACUFEX TUNAV RETROGRADE DRILL by Smith & Nephew, Inc.,
  253. Recall for the product CERAFIT REVISION - Diaphyseal stem - Cementless, Ceraver
  254. Corrective action concerning the use of endoscopic accessories with Pentax Video…
  255. Urgent Field Safety Notice for LifeStream Balloon expandable vascular Covered Stent by…
  256. Roche recalls the Cardiac Reader
  257. Information for users of electro-surgery generators Electrotom 530, 621, 630, 640 and HITT…
  258. Safety Notice for Dimension Vista® System Software Version 3.2.1 or earlier and Dimension…
  259. Software error of cranial / ENT Navigation software, BrainLAB AG
  260. Recall of roller blocks for heart-lung-bypass systems, Maquet
  261. Recall for the Solar 8000M/i Patient Monitor, GE Healthcare
  262. Recall for Immulite 2000/2500 AlaTOP Allergy Screen Assay, Siemens
  263. Safety Notice for the Propaq LT Patient Monitor, Welch Allyn
  264. Safety Notice for AXIOM Artis MP, Artis dMP or Artis zee Multi Purpose, Siemens
  265. Safety Information concerning the pediatric fitting of hearing instruments INTUIS S Dir…
  266. Recall for RF Ablation System Foot-Switch, Boston Scientific
  267. Urgent Field Safety Notice for Leica CM1950 by Leica Biosystems Nussloch GmbH
  268. Safety Notice for Maxi Move Scoop Stretcher, Arjo Hospital Equipment AB
  269. Recall of the CUSA NXT Ultrasonic Surgical Aspirator System, Integra LifeSciences
  270. Corrective action for the MACROLYTE® Premie Dispersive Electrode, ConMed Corporation
  271. Lot recall of Wingman 35 Crossing Catheter, ReFlow Medical
  272. Recall for Frazier and Poole Suction Instruments, ConMed Corp.
  273. Anomaly in Eclipse Photon Single Pencil Beam Convolution from Varian
  274. Important Safety Notice for Focal®, Elekta CMS Software
  275. Urgent field safety notice for SOMATOM FORCE with VA50A / VA50A_SP2 - kernel Hp38, Siemens…
  276. Recall of Thoratec TLC-II Portable VAD Driver from Thoratec
  277. Corrective action for the Camlog Screw Line Implant, ALTATEC GmbH
  278. Urgent field safety notice for surgery gown, Wozabal MPZ Medizinproduktezentrum GmbH & Co…
  279. Recall for Visi-Pro Balloon Expandable Stent System, ev3 Inc.
  280. Recall for the Medtronic Engager™ Transapical Delivery System, Medtronic
  281. Urgent Field Safety Notice for Ohrklappen, unsteril, weiß by Fuhrmann Verbandstoffe GmbH
  282. Urgent Field Safety Notice for several GE Healthcare MRI systems with superconducting…
  283. Information for Biopsy Guide Starter Kit, Philips
  284. Urgent Field Safety Notice for several GE Healthcare MRI systems with superconducting…
  285. Urgent Field Safety Notice for Olympus TJF-Q170V &TJF-Q190V & TJF-Q290 & MAJ-2315 by…
  286. Safety Notice for VITROS® 5600 Integrated System and VITROS® 3600 Immunodiagnostic System…
  287. Corrective action for the Joyce Full Face Mask, Weinmann
  288. Recall of the Architect FSH Calibrator with lot number 33363Q100 from Abbott
  289. Safety Notice for the Digital Linear Accelerators of type PRIMUS™ and ONCOR™, Siemens AG…
  290. Recall of LIL' ANGEL VEST, Össur
  291. Recall RSP Glenoid Inserter, Encore Medical
  292. Urgent field safety notice for Sternal Retractor, Genesee BioMedical Inc. / Landmark…
  293. Corrective action and recall of Roche for Accu-Chek Aviva blood glucose analyzers
  294. Corrective action for MiniCap Extended Life PD Transfer Set with Twist Clamp, Baxter
  295. Urgent Field Safety Notice for Pulmonary Vein Ablation Catheter (PVAC) GOLD by Medtronic…
  296. Information for Ultrasound Transducer 17L5HD, Siemens
  297. Urgent Field Safety Notice for DBS Lead Kit for Deep Brain Stimulation by Medtronic Inc
  298. Safety Notice for MOOG Curlin 6000 and PainSmart
  299. Urgent field safety notice for Universal arm support, TRUMPF Medizin Systeme GmbH + Co. KG
  300. Safety Notice for the device XiO®, Elekta
  301. Recall of Curamed blood glucose monitoring system (starter set), Medisana AG / Aldi Süd
  302. Urgent Field Safety Notice for VICRYL Suture and VICRYL Plus Suture Products by Ethicon…
  303. Corrective action on lubricant diffuser cartridges from Medtronic
  304. Varian informs about the effects of the VARiS Vision plan revision mechanism on total…
  305. Recall for the BVI Visitec® Anterior Chamber Cannula 27G, Beaver-Visitec International…
  306. Corrective action for the VenaSeal™ Closure System, Covidien Deutschland GmbH
  307. Urgent field safety notice for Da Vinci S / Si / Xi Surgical Systems, INTUITIVE SURGICAL
  308. Recall for the product Hyperventilation mask, Yuyao Shengchang Medical Instrument Factory
  309. Corrective Action for IMMULITE / IMMULITE 1000 folic Acid Kit, Siemens
  310. Information about Terumo Advanced Perfusion System 1 - Small Roller Pump and Large Roller…
  311. Urgent Field Safety Notice for ophthalmological Kitpack by Lohmann & Rauscher GmbH & Co…
  312. Recall of several spinal and epidural anesthesia kits by Smiths Medical
  313. Information concerning dysfunctions with the 220-240 V base of the Terumo Advanced…
  314. Lifepak CR Plus
  315. Information about the StarClose Vascular Closure System from Abbott
  316. Recall of DakoCytomation for Envision Plus Visualization Reagent
  317. Recall of BIRMINGHAM HIP RESURFACING Extraction Kit (Instrument), Smith & Nephew…
  318. Urgent Field Safety Notice for Life Scope G9 by Nihon Kohden Corp.
  319. Recall of the Temporary Pervenous Pacing Leads - QSTIM from Biosense Webster
  320. Corrective action for the Philips MobileDiagnost wDR X-ray systems, Philips Medical…
  321. Corrective action for the Galaxy Unyco Diaphyseal tibia sterile kit, Orthofix Srl
  322. Safety Notice for MLCi and MLCi2 Multileaf Collimators, Elekta
  323. Recall of Portex Swivel Adapters and 5 ml Hypodermic Needle- Pro Syringes with needles…
  324. Information about an unexpected behaviour of Perfusor Space, Infusomat Space and Infusomat…
  325. Recall for Neurotrac™MyoPlus2, Verity Medical Ltd.
  326. Urgent Field Safety Notice for Infinity Acute Care System (IACS) by Draeger Medical…
  327. Corrective action and recall for Rotem coagulation analyzers of Pentapharm
  328. Recall for Endoureterotomy Stent Set, Cook
  329. Recall of the surgical sutures Surgilon, Ticron and Sofsilk, Covidien
  330. Urgent Field Safety Notice for ophthalmological Kitpack / Raucoset by Lohmann & Rauscher…
  331. Recall for LIAISON Calcitonin, DiaSorin
  332. Recall for Tibia Offset Stem of the ENDURO / COLUMBUS REVISION Knee System, Aesculap
  333. Urgent Safety Notice for the Luminetx VeinViewer 1.1 GS, Christie Medical Holdings, Inc.
  334. Information about the Amplatzer® Membranous Occluder from AGA Medical Corporation
  335. Information for the product line GammaMed from Varian
  336. Safety Notice for wheelchair REA Azalea Base, Invacare Aquatec GmbH
  337. Urgent field safety notice for Mygo Stander, James Leckey Design Limited
  338. Corrective action for HeartStart MRx, Philips
  339. Urgent Field Safety Notice for oneHbA1c IS by DiaSys Diagnostic Systems GmbH
  340. Safety Notice for ELVeS treatment kit, CeramOptec
  341. Recall for 4.00 Direct measuring Gauges, Smith & Nephew
  342. Lot recall of BD Plastipak 100 ml syringe, ArcRoyal
  343. Dolomite recalls wheeled walking frames Soprano
  344. Recall for Self Tapping Cancellous Screw, SMITH & NEPHEW
  345. Corrective action for Coulter UniCel DxI, Beckman Coulter
  346. Corrective action for the ARCHITECT EBV VCA IgM Controls, ABBOTT
  347. Corrective action of Toshiba X-ray CT scanner, Typ Aquilion/Astion
  348. Corrective action for optimys stems standard and lateral, Mathys Ltd. Bettlach
  349. Urgent field safety notice for TEM pump tube 8170,861 (lot number 1275623), Richard Wolf…
  350. Maquet recalls the surgical suction unit Medap Twista SP 1070
  351. Safety Notice for the device XiO®, Elekta
  352. InterVapor System
  353. LIAISON Borrelia lgG
  354. METASUL large diameter Head
  355. da Vinci Si Single Site Reusable Accessory
  356. Problems with the Corometrics 17x series fetal monitors from GE Healthcare Technologies
  357. Urgent Field Safety Notice for Stiefenhöfer-ERCP-Katheter by medwork GmbH
  358. Information concerning the Picture Archiving and Communication System (PACS) syngo Imaging…
  359. Urgent Field Safety Notice for MAGNUS OP-Tisch by Maquet GmbH
  360. Information about of bolts in ambulance cots model 6500 manufactured by Stryker Europe
  361. Urgent Safety Notice for Waters e-SAT/IN modules, Waters Corp.
  362. Information for ADVIA 1200 System, Siemens
  363. Lot Recall for Circular Stapler 32mm, Stapleline
  364. Urgent Field Safety Notice for URINALYSIS CONTROL - LEVEL 2 by Randox Laboratories Ltd
  365. Corrective action of Oxfords Instruments for SONICAID FM800 cardiotocograph
  366. Recall for 4Z1c Matrix Array Transducer on the ACUSON SC2000, Siemens
  367. Safety Notice for 3M™ Red Dot™ ECG Monitoring Electrode, 3M Healthcare
  368. Terumo Cardiovascular Systems recalls the Sarns Soft Flow Aortic Cannulae with Suture…
  369. Urgent Safety Notice for the CELL-DYN Analyzer, Abbott
  370. Recall for Captia VZV IgM Kit, Trinity Biotech
  371. Corrective action and recall for the m2000sp system from Abbott
  372. Urgent Field Safety Notice for Evita V300; Evita V500; Babylog VN500 by Drägerwerk AG &…
  373. Information for the UV 3003 Theraphy Systems, H. Waldmann
  374. Recall of CK-NAC FS and CK-MB FS reagents from DiaSys
  375. Another Information for Galileo Cervical Disc Prosthesis, Signus
  376. Recall for Reduction Spoon 9 mm, Stryker
  377. Dade Behring recalls the D-Dimer PLUS Testkits
  378. Problem with the Primedic XD1, XD3, XD10, XD30, XD100, XD300, XD110 and XD330…
  379. Urgent Field Safety Notice for Sedaconda by SedanaMedical Ltd Ireland
  380. Further Recall for Langston Dual-Lumen Pigtail catheters, Vascular Solutions
  381. Information for Head rest 1130.67, MAQUET
  382. Urgent Field Safety Notice for Anatomical Shoulder Trial Humeral PE-Insert 40-0 by Zimmer…
  383. Recall of the NE330R Columbus/E.Motion Femural Inserter Extractor from Aesculap
  384. Merit recalls special lots of the 60 ml Viceroy™ Inflation syringe/device
  385. Urgent Safety Notice for the Cios Alpha mobile C-arm x-ray system, Siemens AG
  386. Urgent Field Safety Notice for Leyla Spannarm by Lawton GmbH & Co. KG
  387. Problems with a Bipolar Stepped Needle Electrode from Richard Wolf
  388. Urgent Safety Notice for the Tubing set for Blood Purification, Naniwa Rubber Co., Ltd.
  389. Urgent field safety notice for SmartLife large aseptic housings, Stryker
  390. Urgent Field Safety Notice for LOGIQ P5 by GE ULTRASOUND KOREA, LTD
  391. Batch Recall for the Infusomat Space Line UV-Protect, B. Braun Melsungen AG
  392. Radiometer Medical recalls the D826 accessory kits
  393. Corrective action for AxSym Digoxin III reagent from Abbott
  394. Follow-up Information for the Eon™ Wall Charger Model 3701 and Eon™ Portable Charger Model…
  395. Recall for the Mantis Rod Inserter, Stryker Spine Bordeaux
  396. Information for SPOT PRO, Nucletron
  397. Safety Notice for the Laser Loupes, ORASCOPTIC
  398. Roche recalls the Omni S S1 Rinse solution
  399. Safety Notice for LIAISON® Analyser, DiaSorin
  400. Corrective action/Recall for Lab Vision Pretreatment Module, Thermo Fisher Scientific
  401. Safety Notice for i-STAT Level 2 Control Value Assignment Sheet and i-STAT CLEW A20…
  402. Recall of the Zimmer® Sterile Disposable Tourniquet Cuffs
  403. Safety Notice for Aesculap cementless Bicontact N stem size 9, Aesculap AG
  404. Field Safety Notice for Image-Com Software, TomTec Imaging Systems GmbH
  405. Recall of hemoCare Developer Solution from Care Diagnostica
  406. Urgent field safety notice for LSM - LifeStand Multiposition Wheelchair, Permobil GmbH
  407. Information for DICOMxchange, MeVis BreastCare
  408. Corrective action for the CXP software versions 1.0, 1.1 and 2.0, Beckman Coulter
  409. Recall of Medtronic Model 9013G0711 and 9013G0712 and FHC Model FC1008-66 Motor Options…
  410. Information from Stryker concerning the recall of batteries used in Dell Laptops Model…
  411. Urgent Field Safety Notice for 2.0/2.3 TriLock Plate MC I Base, t1.0 by Medartis AG
  412. Cook Medical Hemospray Endoscopic Hemostat - kasutusjuhendi täiendamine
  413. Zimmer recalls the product Sirus Step Reamer
  414. Information for CASMED 740 Series Multiparameter Monitor, CASMED
  415. Safety Notice for Syngo Dynamics, Siemens
  416. Dimension Vista Hemoglobin A1c (HbA1c)
  417. Recall for One Step Troponin I Raid Test Devices and One Step Myoglobin/CK-MB/Troponin I…
  418. Recall for Neuron Delivery Catheter 0.053, Penumbra
  419. Safety Notice for the Digital Linear Accelerators of type ONCOR™ and ARTISTE™, Siemens AG…
  420. Corrective action for the Dimension clinical chemistry system Tacrolimus (TACR) Flex…
  421. Corrective action for the Dimension clinical chemistry system T3 from Dade Behring
  422. Information for VectorVision Sky and/or BrainSUITE NET, BrainLAB
  423. Corrective action for the Dimension clinical chemistry system T3 from Dade Behring
  424. Safety Information for Hydrolift spine implant, AESCULAP/ B.BRAUN
  425. Urgent Field Safety Notice for Orbera, Obera 365, BIB - Intragastric Ballon System by…
  426. Recalls of the PT2™-Guide Wires from Boston Scientific
  427. Safety Notice for Beatle/Puma - Restraint system for transportation, Handicare
  428. Recall for Mölnlycke ProcedurePaks®, Mölnlycke Health Care
  429. Recall for Thin-Flex Venous Return Cannulae, Edwards Lifesciences
  430. Recall for the Immage Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Beckman…
  431. Urgent Field Safety Notice for Hugo RAS Arm Cart Assembly by Covidien llc
  432. Urgent Field Safety Notice for Finger Spreader by Maillefer Instruments Holding SARL
  433. Recall of Genesis II and Journey Non-Porous Stem Fin Tibial punches from Smith&Nephew
  434. Safety Notice for Separator 032 - Penumbra System, Penumbra Inc.
  435. Safety Notice for the Terumo Runthrough NS Tapered PTCA guide wire, Terumo
  436. Urgent Field Safety Notice for N Latex CDT OPCS by Siemens Healthcare Diagnostics Products…
  437. Further Information about the Recall of the LCS DuoFix Femur in July 2009, DePuy
  438. Lot recall of NC Trek RX Coronary Dilatation Catheter / NC Traveler RX Coronary Dilatation…
  439. Urgent Field Safety Notice for Cannula needle by Applimed SA
  440. Recall of Syphilitop Optima with the lot number 24012 from Biorepair
  441. Atellica UAS 800 Analyzer
  442. Urgent Field Safety Notice for NeuraGen Nerve Guide by Integra LifeSciences Corporation
  443. Corrective action for Wash Zone Mechanism Grounding Kit of the ARCHITECT i2000 and i2000SR…
  444. Urgent Safety Notice for the Covidien Devon™ Light Gloves included in various Kimal…
  445. Exchange of all telescopic drives by chest x-ray Thoravision from Philips
  446. MEDRAD recalls the heat maintainers used on the MEDRAD Stellant CT Injector System
  447. Recall of the Cell-Dyn Sapphire Hemoglobin Reagent Syringes from Abbott
  448. Urgent Safety Notice for Axiom Iconos R100, Siemens
  449. Corrective action for the IMMULITE® 2000/IMMULITE® 2000 XPi Immunoassay Systems, Siemens…
  450. Information about a potential risk of not sufficient stability and tilt resistance due to…
  451. Mistake in the manufacturing process of the SDS ORMCO titanium brackets
  452. Risk of breakage in the backrest of the beds Arminia 2, Westfalia 3, Theutonia 3 and…
  453. Recall of Watusi Guide Wire 0,014 from Micrus Endovascular
  454. Corrective action for BD Microtainer tubes, Becton Dickinson
  455. Field safety notice concerning the KALIX II flat foot implant from Newdeal
  456. Urgent Field Safety Notice for IC9-RS by GE Healthcare Austria GmbH & Co OG
  457. Recall of actuators in hospital beds of cerain serial numbers, Wissner-Bosserhoff
  458. Aesculap recalls Columbus CR Femoral Components
  459. Urgent Field Safety Notice for Philips StentBoost Live used with Philips Allura a by…
  460. Lot recall of specific knee, hip and nail implants, Zimmer Biomet
  461. Recall from the manufacturer C.R. Bard, lots of 20 F Ponsyk Non Balloon Replacement…
  462. Safety Notice for Newdeal Large Qwix Measurer, Newdeal SAS
  463. Information concerning Diode Laser Devices of WDL from Schütz Dental
  464. Information for BenchMark and Discovery Series, VENTANA
  465. Recall Information for defected motors in Dialysis-Chairs and Dialysis-Bed-Chairs, Likamed
  466. Safety Information for Scorpio T72 Tibia Insert Trials, Stryker
  467. Information for Cerclage Pessare Type ASQ, Dr. Arabin GmbH
  468. Recall of Vidas Estadriol from BioMèrieux
  469. Information for MRI Magnet Venting System, Philips
  470. Recall of Micor-Touch Ultra PF Examination gloves from Ansell
  471. Urgent field safety notice for Accu-Chek Connect diabetes management app, Roche Diabetes…
  472. Recall for Safe Mini Oxygenator and Safe Micro Oxygenator, Maquet
  473. Corrective action concerning the Assign SBT Software, Celera / Conexio Genomics
  474. Urgent Field Safety Notice for IMTEC-b2-Glycoprotein I-Antibodies IgG by HUMAN…
  475. Updated Instructions for Use concerning the FerX-ELLA Esophageal Stent - Boubella…
  476. Recall for ISIOTECH, Zeiss
  477. Recall for SoloPath™ Balloon Expandable Transfemoral Introducer, Onset Medical Corporation
  478. Corrective actions concerning the OEC UroView 2800 Systems from GE Healthcare
  479. Urgent Safety Notice for the products AllSet+ Gold and UniTray, Life Technologies
  480. Corrective Action for Gamma ELU-Kit II Buffering Solution, Immucor
  481. Information for Angiostar PLUS, Angiostar TOP, Multistar PLUS, Multistar TOP, AXIOM…
  482. Safety Notice concerning the GH1 and GH3 Trolley guide, Guldmann A/S
  483. Urgent field safety notice for Dimension Vista 500 and 1500 Intelligent Lab System…
  484. Software update for the ETD3 plus Disinfector from Olympus
  485. Recall for Tibial Base Trial, size 3, Waldemar Link GmbH & Co. KG
  486. Urgent field safety notice for Biolox Delta Ceramic Head 32mm, Biomet UK Ltd.
  487. Optima MR430s and MSK 1.5T Extreme
  488. Urgent field safety notice for Zenith Alpha™ Thoracic Endovascular Graft, Cook Medical…
  489. Safety Notice for Targon PFT System - KH 535 R, Aesculap
  490. Lot Recall for Summit Universal Broach Handle, DePuy
  491. Information for Solar 8000M/i, GE Healthcare
  492. Safety Notice concerning a corrective action of the Lifepak 500 automated external…
  493. Urgent Field Safety Notice for Philips StentBoost Live used with Philips Azurion by…
  494. Corrective action for Thromborel S, Dade Behring
  495. Safety Notice for Active Cortisol ELISA, Beckman Coulter
  496. Recall of Yellow-Star-Tumor Stents, PC-couted Double-J Ureteral Stents from Urotech
  497. Information concerning the Disposable Multi Absorber Canister with the EZchange Module…
  498. Lot Recall for FreshLook® colors contact lenses, CibaVision
  499. Updated Safety Notice concerning the automated Blood Collection, Terumo
  500. Information concerning the BV Pulsera and Endura Release 2 systems of Philips Medizin…
  501. Recall for GlucoTel blood glucose meter, BodyTel Europe GmbH
  502. Notification of Medtronic for the Midas Rex Legend Pneumatic System

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