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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 Hiluron 1 % & 1,4 %, Eyeol U.K. Limited
  2. Corrective action for the Pulsar-18 and Pulsar-35 peripheral self-expanding Nitinol stent…
  3. Recall of the acrylic intraocular lens MC AS from HumanOptics
  4. Information about the correct use of the EOLE battery pack from ResMed
  5. Recall for Synthetic Leather and Biothane Waist and Wrist Restrains, MDSS
  6. Corrective action of Olympus Diagnostica for Olympus AU400, AU600, AU640, AU2700 and…
  7. Customer Information concerning the surgical lights Admeco-Lux
  8. Safety Information for the RELIANCE 4-FRONT single coil defibrillation leads, Boston…
  9. Ring Applicator, 45° Set Ring Applicator, 60° Set Ring Applicator, 90° Set
  10. Safety Notice for Model 3387, 3387S, 3389 and 3389S, Deep Brain Stimulation (DBS) Lead…
  11. The influence of low-molecular-weight heparin (LMWH) on DNA in the blood plasma of…
  12. Recall - Field Correction for ILUMA Vision Software, IMTEC a 3M Company
  13. Urgent field safety notice for ABX PENTRA 400 (version 5.0.8 or lower) and PENTRA C400…
  14. Baxter recalls the Sabra set
  15. Corrective action of Dade Behring for Thromborel S
  16. Recall of the Femoral Venous Cannula Wire Reinforced from Sorin Group
  17. Recall of Safil violett 0 (3,5) (lot number 1-4133) from Aesculap
  18. Recall of Hantavirus Puumala Antibody IF-Test, Progen
  19. Urgent Field Safety Notice for IRIDICA Bead Beater (BB) by Abbott Molecular, Inc
  20. Recall of Interlocking Detachable Coils for Occlusion from Boston Scientific
  21. Recall for PKS SEAL Open Forceps, Gyrus ACMI
  22. Lot Recall for CT Drainage Set, Direct puncture set with pigtail catheter, OptiMed
  23. Corrective action for the Zeus Infinity Empowered (IE) anaesthesia workstation with…
  24. Urgent Field Safety Notice for HeartMate II System Controller by Thoratec Corporation
  25. Recall for SYNCHRON® Rheumatoid Factor (RF) Reagent, Beckman Coulter
  26. Corrective action and recall of Immucor for the Galileo Analyzer
  27. Important Safety Notice for MOSAIQ-Version 1.60V1 to v2.30.01, ELEKTA
  28. Safety Notice/Recommendations for the safe use of the Catalys® Precision Laser System…
  29. Urgent Field Safety Notice for PRECISE PRO Rx Carotid Stent System by Cordis Corporation
  30. Recall for ΩConnector, HEINZ KURZ
  31. Urgent Safety Notice for the OPTIMEDICA Catalys® Precision Laser System, OptiMedica…
  32. Safety Notice for Varian Proton Therapy Delivery System, Varian
  33. Information for the VITROS 5600 Integrated System, Ortho-Clinical Diagnostics
  34. Corrective action for the NAV3i Platforms and Power Box, Stryker
  35. Safety Notice/Recall for the product "Lampengriffbezüge", Fuhrmann GmbH
  36. Recall Adept Acetabular Cups, Finsbury
  37. Information for STERRAD CYCLESURE® and CYCLESURE® 24 Biological Indicator(s), Johnson &…
  38. Corrective action for the product AutoFIX™ 3.0/4.0 non sterile range, SBI International
  39. Safety Notice related to the Synthes SynFix-LR Technique Guide, Synthes
  40. Recall of VI AUF Stent Graft and VI Extender Cuff from INTERVASCULAR
  41. Safety Notice for XiO®, Elekta CMS Software
  42. Safety Notice for the HeartStart MRx M3536A defibrillator/monitor, Philips Healthcare
  43. Problems with the audible alarm of Neonatal Respiration monitors from Smiths Medical
  44. Safety Notice for PowerPro, PowerProMax and Mpower Handpieces, ConMed Linvatec
  45. Corrective action for Synchron Systems LX20 and UniCel DxC Systems only GLU Reagent…
  46. Lot Recall for the NexGen Complete Knee Solution Femoral and Provisional Impactors and…
  47. Lot recall of Vanguard Rocc / Vanguard Alpina / Alpina APS / Alpina APR / Alpina Uni /…
  48. Safety Notice for BrainSCAN and iPlan RT Dose, BrainLAB
  49. Recall for ATEC® Breast Biopsy and Excision System-ATEC Handpiece, Hologic, Inc.
  50. Urgent field safety notice for Soluscope endoscope washer-disinfector Serie 3 GTA…
  51. Information for Disposable Irrigation Cannula with Bulbous Tip G-34335, Geuder
  52. Urgent field safety notice for CDI Blood Parameter Monitoring System 500 / BPM Sensor Head…
  53. Urgent Field Safety Notice for MAJ-209 SINGLE USE SUCTION VALVE by Olympus Medical Systems…
  54. Safety Notice for Universal Cable, ConMed Linvatec
  55. Software discrepancy of the Verify and Record systems IMPAC MOSAIQ version 1.20L1-P4 from…
  56. Urgent Field Safety Notice for HeartWare Ventricular Assist System by Heartware, Inc.
  57. Safety Notice for IGFBP-3 IRMA kits, Beckman Coulter
  58. Urgent Field Safety Notice for Estradiol by Demeditec Diagnostics GmbH
  59. Field Safety Notice regarding „ Power Station, type number 0101-24937 and 0701-24906”…
  60. Corrective action for the FEMTELLE® uPA/PAI-1 kit, Sekisui Diagnostics
  61. Urgent Field Safety Notice for TCM5 Calibration Gas by Radiometer Basel AG
  62. Urgent Field Safety Notice for Pulsar-18 by BIOTRONIK AG
  63. Recall of BioMerieux for Campylosel agar
  64. Recall for Architect Pre-Trigger Solution, Abbott
  65. Corrective action concerning Cover 15+25mm for acetabular cup, Stemcup Medical Products AG
  66. Urgent Field Safety Notice for RegJoint by Scaffdex Oy
  67. Recall for Troponin I Rapid Test Devices and Myoglobin/CK-MB/Troponin I Combo Test…
  68. Recall for PediCap End-Tidal CO2 Detectors, Covidien
  69. Recall of Impact attachment ND270Rfor pre-assembled Plasmacup® delta, Aesculap AG
  70. Information about the Level-1 system from Smiths-Medical Deutschland GmbH
  71. Urgent Field Safety Notice for balanSys Femur Holder by Mathys AG Bettlach
  72. Information concerning the OEC Miniview 6800 systems from GE Healthcare
  73. Corrective action for Ventana staining platforms from Ventana Medical Systems
  74. Safety notice concerning the OEC 9900, OEC 9800 and OEC 8800 X-ray systems from GE…
  75. Urgent Field Safety Notice for Life Scope G9 by Nihon Kohden Corp.
  76. Safety Notice for the HexaPOD evo RT System, Medical Intelligence Medizintechnik GmbH
  77. Urgent Field Safety Notice for Vitrectomy TDC Kit. (23 gauge / 0.6 mm) by D.O.R.C. Dutch…
  78. Urgent Field Safety Notice for CryoMACS Freezing Bag 750 by Miltenyi Biotec GmbH
  79. Recall of orthopaedic implants from Biomet France
  80. Safety Notice concerning a corrective action of the long-term electrocardiogram (ECG)…
  81. Recall of the RSV IgM ELISA IgM cut-off Control, Sekisui Virotech GmbH
  82. Recall of TC-100 bone screws from Smith & Nephew
  83. Urgent field safety notice for bellavista ventilator, imtmedical ag.
  84. Urgent Field Safety Notice for Ultrafilter U 9000 by Gambro Dialysatoren GmbH
  85. Corrective action and recall of Dade Behring for the BEP 2000 and the BEP 2000 Advance…
  86. Recall of DetachaTip Multi-Use Laparoscopic instruments and diposable graspers and…
  87. Impulse Angiograhic (Diagnostic) Catheter
  88. Recall for ABL77 cal pack lots from Radiometer Copenhagen
  89. Corrective action for the WIZARD2 Gamma Counter, PerkinElmer
  90. Recall of the guide wires from C.R. Bard GmbH
  91. Safety Notice concerning a problem with Dynamic Conformal XiO RFC 33941, Elekta
  92. Recall of the Lumenis DuoTome SideLite™ 550 Micron Delivery System from Lumenis
  93. Recall of Genesis II knee system from Smith & Nephew Orthopaedics GmbH
  94. Lot Recall for "BAYHA-Skalpellklingen Nr. 22 steril", C. Bruno Bayha GmbH
  95. Urgent Field Safety Notice for MiniCollect 9NC Coagulation Tube by Greiner Bio-One GmbH
  96. Corrective action for Dimension Vista V-LYTE Standard A (K820), Siemens
  97. Corrective action of Beckman Coulter for Coulter LH 750 Hematology Analyzers
  98. Corrective action for IH-Com Full kit version, BioRad
  99. Information concerning the Technegas Generators from Cyclopharma
  100. Safety Notice for syngo Imaging, Siemens
  101. Corrective action and recall of Ortho Clinical Diagnostics for AutoVue Innova/Ultra
  102. Urgent Safety Notice for all HeartWare® HVAD Systems, HeartWare Inc.
  103. URGENT - Field Safety Notice for Philips IntelliVue Information Center (PIIC) iX, Philips
  104. Safety Information for Primus, Apollo and Pallas anaesthesia machines, Dräger
  105. Lot Recall for Resofix, RESOIMPLANT
  106. Recall for LuMend OUTBACK® LTD® Re-Entry Catheter, Cordis
  107. Recall for 24k® Arthroscopy Outflow/Suction Tubing sets, ConMed Linvatec
  108. Advisory Notice for syngo CT 2007S SP3, Siemens
  109. Lot Recall for chronOS Cylinder and chronOS Insert, SYNTHES
  110. Urgent field safety notice for Wilson Frame Pads, Mizuho Orthopedic Systems Inc.
  111. Urgent Field Safety Notice for recomLine Helicobacter 2.0 IgG/IgA by Mikrogen GmbH
  112. Recall of transtracheal Jet-Ventilation catheter from VBM Medizintechnik
  113. Safety Notice for ultrasound system SSD-ALPHA10, ALOKA
  114. Corrective action for the CoaguChek PT-Test of Roche
  115. Safety Notice for Enterra Therapy System, Medtronic
  116. Corrective action for Vitros Chemistry Products mALB Reagent Generation 2, 3 und 4, Ortho
  117. Urgent Field Safety Notice for Hy-Care (multi-purpose solution) by CooperVision…
  118. Recall of the VAC Instill vacuum tubing from KCI Medical Products
  119. Information concerning the Corpuls 3 defibrillator from GS Elektromedizinische Geräte
  120. Information for Bipolar Heads in Steel, Mathys
  121. Safety Notice for Trident Acetabular System, Stryker
  122. Recall for Mentor® Gel Sizers, Mentor Medical Systems B.V.
  123. Urgent field safety notice for ACUSON S ultrasound systems, Siemens Medical Solutions
  124. Recall of plug power supplies used for chargers for rechargeable hearing aids, Siemens…
  125. Recall BD 60 ml Luer-Lok Syringes, Medtronic
  126. Corrective action of Microm for HM355 S, Microm
  127. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
  128. Recall for Ratiomed Troponin I, Megro
  129. Urgent safety information concerning the glass capillary tubes of the CRP tests, nal von…
  130. Recall of Dade Behring for the Dimension clinical chemistry system RCRP
  131. Recall of truCATH pulmonal artery catheters from Omega Critical Care
  132. Recall of the resorbable bone screws Calaxo from Smith & Nephew
  133. FUJIFILM 7000 Video Processor
  134. Additional warning from Baxter BioScience for the product CoSeal
  135. Safety Notice for TheraScreen® K-RAS Mutation Kit, QIAGEN Manchester Ltd.
  136. Recall of SUTUREFIX Ultra Anchors, Smith & Nephew
  137. Urgent Field Safety Notice for Otesus by Maquet GmbH
  138. Urgent Safety Notice for the product Leksell GammaPlan® 10.2, Elekta Instrument AB
  139. Corrective action for the Shiley™ Neonatal and Pediatric products, Covidien LLC
  140. Urgent Safety Notice for the Femoral PU Cannulae Arterial and Venous, Sorin Group Italia
  141. Urgent Field Safety Notice for Hospira PCA3 by Hospira Inc. USA
  142. Urgent Field Safety Notice for Vapotherm Oxygen Assist Module (OAM) by Vapotherm Inc…
  143. Urgent Field Safety Notice for Inquiry Steerable Diagnostic Catheter by S.. Jude Medical…
  144. Urgent Safety Notice for the IntraClude™ intra-aortic occlusion device Model ICF100…
  145. Becton Dickinson recalls several lot numbers of the peridural anaesthesia products
  146. Urgent Field Safety Notice for MultiDiagnost Eleva with Flat Detector, Allura Xpe by…
  147. Recall for the IGF-I IRMA Kit from Beckman Coulter
  148. Urgent Field Safety Notice for RegenET by Regen Lab SA
  149. Recall for the Data Innovations Instrument Manager from Beckman Coulter
  150. Recall/Corrective action for Varelisa U1RNP Antibodies Kit, Phadia
  151. Urgent Field Safety Notice for MX40 Intellivue by Philips Medical Systems
  152. Safety Notice for LikoScale 200, 350 and 400, Liko
  153. Urgent Safety Notice for the Adaptive Servo-Ventilation (ASV) Therapy (SleepOne ProSV and…
  154. Urgent Field Safety Notice for t:slim X2 Insulin Pump by Tandem Diabetes Care, Inc
  155. Urgent Field Safety Notice for Sinus-SuperFlex-635 by optimed Medizinische Instrumente…
  156. Corrective action for the RAPIDLab 1260 and RAPIDLab 1265 Blood Gas analyzers, Siemens…
  157. Urgent Field Safety Notice for Virotech SetCards für LabImage LA by Virotech Diagnostics…
  158. Urgent Field Safety Notice for Epsylar Percutaneous Introducer Sheath by optimed…
  159. Urgent Field Safety Notice for Cliny Port System by Create Medic Co., LTD.
  160. Urgent field safety notice for mobile X-ray devices / C-arms, Ziehm Imaging GmbH
  161. Recall of the Vario Knee System Resection Guide Femoral Distal from Plus Orthopedics
  162. Urgent Field Safety Notice for Lifepak CR2 by Physio-Control, Inc.
  163. Safety Notice for Connector HG 0286, Maquet
  164. Recall of Bremer Halo and Skull Pin products from DePuy
  165. Software Update for the STP 420D/ES Tissue Processor, Microm International (Thermo Fisher…
  166. Safety related software upgrade all XVI R4.5-Systems, Elekta
  167. Urgent field safety notice for M2a 38mm Acetabular System, ZIMMER BIOMET
  168. Safety Notice for Motion Enabel Switch for Therapy Simulator Systems, Siemens
  169. Corrective action for ADVIA Centaur® and ADVIA Centaur® XP, Siemens
  170. Recall for Covidien Devon™ Light Glove (lamp handle sleeve) in Secu® Tray OP sets…
  171. Safety Notice for the AMO STAR S4 IR Excimer Laser System, Abbott Medical Optics Inc.
  172. Urgent Safety Notice for the product RayStation, RaySearch Laboratories
  173. Recall of Full Radius 4,5 mm Concave 180 mm Long Disposable Blade, Smith & Nephew
  174. Urgent field safety notice for washer-disinfectors PG 8527 / 8528 / 8535 / 8536, Miele &…
  175. Urgent Field Safety Notice for T2 Rigid Reamer by Stryker Trauma Kiel
  176. Recall of Cord Cells with the lot number 374.188 from Medion
  177. Recall of the hydrophobic acrylic intraocular lens Hydromax from Carl Zeiss Meditec
  178. Corrective action for OPTIGUN RATCHET and OPTIGUN RATCHET US, Biomet
  179. Urgent Field Safety Notice for Dimension Tacrolimus (TACR) Flex reagent cartridge…
  180. Recall of the Binax NOW Legionella Urinary Antigen 22 Test Kit from Binax
  181. Safety Notice for several stretchers, Stryker
  182. Safety Notice for Seno Advantage Workstations 2.1 und 2.2 with RIS CCOW integration, GE…
  183. Recall for Arthri-Slidex, BioMérieux
  184. Recall of various sterile gauze products, Paul Hartmann AG
  185. Safety Notice concerning a corrective action of the linear accelerator systems Hi Art…
  186. Safety Notice for HeartMate II LVAS System Controller, Thoratec Corporation
  187. Recall for Chocolate Agar with Vitox, Oxoid Deutschland / Thermo Fisher Scientific
  188. Safety Information for Intrathecal Catheters in drug delivery systems SynchroMed and…
  189. Safety Notice for iTotal CR Knee Replacement System, Conformis
  190. Corrective action for the Tytin Regular Set, Kerr Corporation
  191. Recall for TruCal Homocysteine FS, TruLab Homocysteine FS Level I and TruLab Homocysteine…
  192. Safety Notice for the Acrobat 3000 spring arm, Trumpf Medizin Systeme GmbH + Co. KG
  193. Preventive Maintenance Instructions for the 3D-TOP Ceiling Stand, Siemens
  194. Safety Notice for Sutureless Connector (SC) Intrathecal Catheters, Medtronic
  195. BD Max Reagents
  196. Recall of the Colorado 2 Locking Nuts from Medtronic
  197. Safety Notice for Innova 2000 and 4100, GE Healthcare
  198. Corrective action for the RAPIDPoint® 500 System, Siemens
  199. Safety Notice for accessory connection bracket, Maquet
  200. Safety Notice for Innova 2000, 3100 and 4100 cardiovascular X-ray systems, GE Healthcare
  201. Safety Information for digital linear accelerators, Siemens
  202. Lot-Recall for Wingspan™ Stent System, BOSTON SCIENTIFIC
  203. Corrective action for the Ingenia MR FlexTrak Trolley, Philips Healthcare
  204. Problems with the Extended Brilliance Workspace Workstation from Philips
  205. Corrective action for the FUJIFILM Digital Mammography System AMULET, FUJIFILM
  206. Lot recall of Covidien Devon™ Light Gloves, MSP Schmeiser GmbH
  207. Urgent Safety Notice for the Alere Triage® BNP Calibrator for the Beckman Coulter Access…
  208. The company Intuitive Surgical notified customers of the da Vinci ® surgical system
  209. Lot Recall for Hydrolift spine implants, AESCULAP
  210. Urgent Field Safety Notice for Beneview T1 Patient Monitor by SHENZSHENZHEN MINDRAY…
  211. Safety Notice for Innova 2121IQ, 3131IQ, 2100IQ, 3100IQ and 4100IQ, GE Healthcare
  212. Safety Notice concerning the revision of the Instruction for Use, Zimmer GmbH
  213. Urgent field safety notice for Uni-Gold LUA Plus, Trinity Biotech
  214. Corrective Action for IMMULITE 2000/2000 XPi Erythropoietin and IMMULITE 2500…
  215. Safety Information for the monopolar hook electrode, Gebrüder Martin GmbH & Co. KG
  216. Urgent field safety notice for Digitoxin Reagent, Roche Diagnostics
  217. The company Haag-Streit AG notified customers of a possible leaking of tonometer prisms
  218. Safety Notice for Bilirubin Auto Total FS, DiaSys Diagnostics Systems
  219. Corrective action for the Abbott Clinical Chemistry Alkaline Wash, Abbott Diagnostics
  220. Recall / Corrective Action for m2000sp Instrument, Abbott
  221. Urgent Field Safety Notice for SOLTIVE SuperPulsed Laser System by Gyrus ACMI, Inc.
  222. Urgent Field Safety Notice for MultiDiagnost Eleva - UroDiagnost Eleva - OmniDi by Philips…
  223. Information for implantable neurostimulators, Model 7428 Kinetra and 7426 Soletra…
  224. Urgent Field Safety Notice for RUSCH Connectors Bulk for Breathing Circuits by Teleflex…
  225. Boston Scientific recalls Stainless Steel Greenfield™ Vena Cava Filter
  226. Information for BRAVO, GE Healthcare
  227. NIM Trivantage™ EMG Endotracheal tube
  228. Urgent Safety Alert for CADD®-Solis Ambulatory Infusion Pumps, Smiths Medical…
  229. Recall of Diamed for ID-Anti-Lea and AP P1-Lea-Leb-Lua-Lub-CtI
  230. Recall for the Langston V2 Dual Lumen Catheter, Vascular Solutions, Inc.
  231. Corrective action for the EmbryoScope time-lapse incubator, Unisense FertiliTech A/S
  232. Urgent Field Safety Notice for PIPELINE VANTAGE WITH SHIELD TECHNOLOGY by Micro…
  233. Corrective action for LeukoSure™ of Beckman Coulter
  234. Corrective action for the CT Exprès™ contrast media injection system, Bracco Injeneering…
  235. Lot Recall for Theralite High Cut-Off-dialyzer, Gambro
  236. Urgent Safety Notice for the Digital Linear Accelerators of type ARTISTE™, ONCOR™ and…
  237. Urgent Field Safety Notice for MATCH IT! DNA software by immucor GTI Diagnostics, Inc.
  238. Lot recall of ImmuView S. pneumoniae and L. pneumophila urinary antigen test, SSI…
  239. Recall for various orthopedic products, Biomet Orthopedics
  240. Lot recall of PROBE Verankerungsschaft gebogen Gr. Ø13 x 200 mm / Ø14 x 200 mm, PETER…
  241. Recall for the product Gelseal Straight, Vascutek Ltd.
  242. Urgent Field Safety Notice for simply InterActive Implant by Implant Direct Sybron…
  243. Urgent Field Safety Notice for Dimension Vista Magnesium Flex reagent cartridge by Siemens…
  244. Corrective action for Bio-Rad Whole Blood Controls, Alba Bioscience
  245. AQURE system, AQURE/FLEXLINK
  246. Corrective action and recall of Becton Dickinson for the BBL™ GasPak™ Anaerob Pouch System…
  247. Safety Notice: Defect in SEQUENCER for MOSAIQ, IMPAC Medical Systems
  248. Recall of the 4.5 mm Cortical Screws listed as compatible with the M/DN system, Zimmer…
  249. Urgent Field Safety Notice for Novocastra by Leica Biosystems Newcastle Ltd
  250. Recall for Orthopaedic bone-nailing compression screw / Orthopaedic instrument connecting…
  251. Safety instructions for the Translux Power Blue polymerization lamp from Heraeus Kulzer
  252. Urgent Field Safety Notice for Centricity PACS IW by GE HEALTHCARE INTEGRATED IT SOLUTIONS…
  253. Urgent Field Safety Notice for T.E.S.S. (Total Evolutive Shoulder System) by Biomet France…
  254. Information for Recalibration of the Command Modules 90496 and 91496, Spacelabs Healthcare
  255. Safety Notice for Medtronic CoreValve® Delivery system, Medtronic
  256. Urgent Field Safety Notice for TEE Probes by GE Vingmed Ultrasound A/S
  257. Urgent Field Safety Notice for Venflon Pro Safety by Becton Dickinson Infusion Therapy AB
  258. Urgent Field Safety Notice for Normed Charcot Osteotome Chisel by Zimmer GmbH
  259. Urgent Field Safety Notice for Dade Ci-Trol 1 by Siemens Healthcare Diagnostics Products…
  260. Recall for Dimension Vista Flex reagent cartridges IGM, Siemens
  261. Safety Notice for Eclipse: Error in calculating multiple carriage group IMRT fields with…
  262. Safety Notice for Medical Temperature Probe Adaptor, Spacelabs Healthcare
  263. Urgent Field Safety Notice for InterActive Healing Collar by Implant Direct Sybron…
  264. Recall for TPHA 100, Biomerieux
  265. Urgent Field Safety Notice for REVITAN prox. spout 75 by Zimmer GmbH
  266. Safety Notice for the RT-Plus Modular surgical technique, Smith & Nephew
  267. Corrective action for Gel-E Donut and Squishon 2 gel-filled products, Philips/Children’s…
  268. Lot recall of UrgoTül, URGO GmbH
  269. Safe handling of Tracheoflex cannulas from Teleflex Medical and Willy Rüsch
  270. Exchange of siderail screws in hospital beds Eleganza 3 and Eleganza 3XC, Linet
  271. Safety Notice for all HL 20 Twin Pump Modules - Release Version 11, Maquet Getinge Group
  272. Safety Notice for the HL 20 - 4 pump consoles and HL 20 - 5 pump consoles, Maquet Getinge…
  273. Minimally Invasive Reduction Screw: replacement of surgical technique, Synthes
  274. Corrective action for the MAGNUS Hybrid OR table, MAQUET GmbH
  275. Safety Notice for Eclipse and RT Chart software, Varian Medical Systems
  276. Corrective Action for BD Phoenix System Software and BD Phoenix Update Disks, Beckman…
  277. HeartWare Ventricular Assist System
  278. Boston Scientific recalls the Flextome Cutting Balloon™ Device Monorail™ Delivery System…
  279. Information for Procedure Paks, Mölnylycke Health Care
  280. Urgent Field Safety Notice for LogiCal Pressure Monitoring Kit by Smiths Medical ASD, Inc…
  281. Safety Notice concerning 4008 pediatric bloodlines, Fresenius Medical Care
  282. Urgent Field Safety Notice for implacross PE insert 10° Ø 28/35mm by implantcast GmbH
  283. Recall for Renegade Fiber Braided Microcatheter, Renegade Hi-Flo Microcatheter and…
  284. Urgent Safety Notice: Correct use of measuring spoons, Joma GmbH
  285. Corrective action for syngo® RT Therapist 4.3.SP1 and syngo® RT Oncologist 4.3.SP1…
  286. Urgent Field Safety Notice for Valiant Navion Thoracic Stent Graft System by Medtronic Inc
  287. Corrective action for Immulite 2000 / 2500 Androstenedione, Siemens
  288. Urgent Field Safety Notice for VDR4 Phasitron Breathing Circuit Kit by Percussionaire…
  289. Recall for the JETSTREAM SC® and JETSTREAM XC® Atherectomy Catheter, Bayer Healthcare
  290. Urgent field safety notice for Aero Blue performance surgical gown, Halyard / Kimberly…
  291. Urgent Field Safety Notice for VITROS SARS-CoV-2 Antigen Reagent by Ortho Clinical…
  292. Urgent Field Safety Notice for astraia software for women's health by astraia software…
  293. Important Notice for XVI, Elekta Ltd.
  294. Lot Recall of the Tendon Stripper, Smith & Nephew
  295. Corrective action for the ADVIA Centaur® TNI-Ultra ReadyPacks®, Siemens Healthcare…
  296. Safety Notice for OEC Flexiview 8800 X-ray system, GE Healthcare
  297. Safety Notice for the Trypticase™ Soy Agar with 5% Sheep Blood (TSA II™) // MacConkey II…
  298. URGENT FIELD SAFETY NOTICE for ProcedurePak®, Mölnlycke Health Care
  299. Information about M3001A Multi Measurement Server (NMS), M1020B Pulse Oxymetry Module…
  300. Recall for NOVOCART® 3D Pin FR736, Aesculap
  301. Corrective action for the CELLSEARCH® Circulating Tumor Cell Kits, Janssen Diagnostics…
  302. Recall of PENTARAY catheters, Johnson & Johnson Medical NV/SA / Biosense Webster
  303. Recall and corrective action for FC 500 MPL Flow Cytometry Systems with MXP Software…
  304. Corrective Action of the programmer software for Reply SR single chamber pacemakers from…
  305. Safety Notice for Avance, Amingo and Aisys anaesthesia systems, GE Healthcare
  306. Lot Recall of Radiation Shields flat for the Intrabeam Radiosurgery Treatment system, Carl…
  307. Corrective action for Navigation Software Spine & Trauma 3D 2.0 and 2.1, Brainlab AG
  308. Urgent Field Safety Notice for JOURNEY UNI CoCr Femoral: by Smith & Nephew, Inc.,
  309. Urgent Safety Notice for the Digital Radiography X-Ray System DX-D 100, Agfa HealthCare
  310. Corrective action for the MicroScan WalkAway plus Instrument, Beckman Coulter
  311. Urgent field safety notice for NBS System 4 / 5, Nexstim Plc
  312. Corrective action for the Hamilton Galileo Ventilator Flexport, Spacelabs Healthcare
  313. Recall for Platinum PLUS™ Guidewire (peripheral), Boston Scientific
  314. Recall for the Basin Liner, Microtek Medical, B.V.
  315. Recall for the Basin Liner, Microtek Medical, B.V.
  316. Information for Delta XTEND Shoulder Prosthesis, DePuy
  317. Recall of Becton Dickinson for the BD™ PhoenixSpec™ Calibrator Kit
  318. Safety Notice concerning a problem of the compatibility of the Olympus ETD series…
  319. Corrective action for TriniCHECK D-Dimer High, Tcoag Ireland
  320. Recall for Contour SE Microspheres, Boston Scientific
  321. Corrective Action for ABL800 and ABL700, Radiometer
  322. Urgent Field Safety Notice for POWER LOAD by Stryker Medical-Kalamazoo
  323. Urgent Field Safety Notice for LiquiBand FIX8 by Advanced Medical Solutions (Plymouth) Ltd
  324. Urgent Field Safety Notice for GOT Multi C2F6 by Al.CHI.MI.A. SRL
  325. Safety Notice for CELL-DYN Analyzer, Abbott
  326. Recall of PROPAQ LT Patient Monitors from WelchAllyn
  327. Urgent Safety Information/Corrective action for the Automatic tourniquet „kariba“, ulrich…
  328. Corrective action and recall of Beckman Coulter for Cytomics FC 500 with CXP Software
  329. Information from Siemens concerning examinations which are opened under RIS control
  330. Information for the Centiva/5 and the Centiva/5 Plus critical care ventilators from GE…
  331. Urgent field safety notice for Analyst MD Software, SCIEX
  332. Urgent Field Safety Notice for neoBLUE LED Phototherapy System by Natus Medical…
  333. Urgent Field Safety Notice for Lithium_2 (LITH_2) reagents Enzymatic Hemoglobin A1c…
  334. Recall for Encore® Microptic® surgical gloves, Ansell
  335. Safety Notice for certain Nuvo, Nuvo 8 and Nuvo Lite branded oxygen concentrators, Nidek…
  336. Urgent Field Safety Notice for HeartStart FRx, HeartStart HS1 (HeartStart OnSite…
  337. Urgent Field Safety Notice for AlboGraft Polyester Vascular Graft by LeMaitre Vascular…
  338. Recall of the N5600 und N5600Plus/P Multi Parameter Monitors, Mediana
  339. Lot Recall for Sopira Carpule Needles, HERAEUS
  340. Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland…
  341. Recall SN connector, article 1703, Serumwerk Bernburg
  342. Recall for TOPRO Olympos rollator, Handicare
  343. Lot Recall for Turbo-Booster Laser Guide Catheters, Spectranetics
  344. Alinity hq Analyzer
  345. Information for HD3 Ultrasound Systems, Philips
  346. Urgent Field Safety Notice for Different Zeta Corp Lab reagents by Zeta Corporation
  347. Medical Device Correction for HDI4000 Ultrasound Systems, Philips
  348. Safety Notice for Sarns™ Disposable Centrifugal Pump, Terumo
  349. Lot recall of TriForce peripheral crossing set, Cook Medical Europe
  350. Recall of endotracheal tubes and tracheal tube exchangers from Hudson RCI Tecate, Teleflex…
  351. Urgent Field Safety Notice for ETEST ETP32 (Ertapenem) by bioMérieux SA (Marcy- l'Etoile)
  352. Urgent Field Safety Notice for ZomaJet Durchstechflaschen-Adapter by Ferring…
  353. Corrective Action of Siemens for IMMULITE / IMMULITE 1000 Insulin and IMMULITE 2000 /…
  354. Recall for the HydroFinity™ Guidewires, Covidien
  355. Recall of the PRI Femoral Impactor Head instruments, Zimmer, Inc.
  356. Urgent field safety notice for Lotus™ Valve System, Boston Scientific International S.A.
  357. Information concerning the Alaris PK Pump in conjunction with the Propofol-Schnider…
  358. Corrective action for Apheresis System MCS+ 9000, Haemonetics
  359. Corrective action for the product LifeCycle for Prenatal Screening, PerkinElmer/Wallac Oy
  360. Corrective action for the product astraia software for women’s health, astraia software…
  361. Recall for PSA tests and analyzers TPS-401, TPS-402, TPS-402H, TPS-422, und TPS-U402…
  362. Recall for Gentleman walking frame, Meyra Ortopedia
  363. Recall for the Covidien Devon Light Gloves (Light handle covers), ArcRoyal Ltd.
  364. Urgent Field Safety Notice for Charging Unit mounted T DC TS 7500 by TRUMPF Medizin…
  365. cobas b123 POC System
  366. Safety Notice for syngo Imaging XS, Siemens
  367. Recall for the Steel cannula infusion sets, Unomedical a/s
  368. Urgent field safety notice for PerFuse Decompression Instrument, Zimmer Biomet
  369. Urgent Field Safety Notice for Artis icono and Artis pheno by Siemens Healthcare GmbH…
  370. Urgent Field Safety Notice for LIFE I8 - Theraline pro Tubing set by Miltenyi Biotec GmbH
  371. Corrective action for Vidas C. difficile Toxin A&B from of bioMérieux
  372. Lot recall for ID-Papain, Bio-Rad / DiaMed GmbH
  373. Recall for Stat Profile CCX Creatinine Membrane Kits, Nova Biomedical
  374. Corrective action for Artis zee Floor, Artis zee Biplane, Artis zee Multi Purpose systems…
  375. Recall of the Renegade™ Hi-Flo Microcatheter Kit from Boston Scientific
  376. Urgent Recall for Portex Uncuffed Paediatric Sized Tracheal Tubes, Smith Medical
  377. Recall for BigLumen Aspiration catheter, OptiMed
  378. Safety Notice for Calcium P FS, DiaSys
  379. Batch recall of SwiveLock SP Suture Anchor, Arthrex GmbH
  380. Recall for the CRIT-LINE® Blood Chamber, Fresenius USA Manufacturing, Inc.
  381. Urgent Field Safety Notice for LIFEPAK CR2 defibrillator by Physio-Control, Inc.
  382. Safety Notice for Centricity CARDDAS V3.1, GE Healthcare
  383. Corrective action for MicroScan Dried Overnight Gram Negative and Synergies plus Negative…
  384. Corrective action for Alcon Monarch® IOL Delivery System Cartridges, Alcon Laboratories…
  385. Safety Notice for Axiom Artis systems, Siemens
  386. Urgent Safety Notice for the Marus LuxStar dental lights, Dental Equipment LLC (dba Marus)
  387. Safety Notice for Cobas c501/c6000, Roche
  388. Safety Notice for SynchroMed EL and SynchroMed II, Medtronic
  389. Urgent Field Safety Notice for GEM Microvascular Anastomotic Coupler by Synovis Micro…
  390. Safety Notice for Pentax Light Sources BS-LH 1; BS-LH 2; BS-LL 1, Pentax
  391. Corrective action regarding Medidrug ALC VB, MEDICHEM Diagnostica GmbH & Co. KG
  392. Corrective action for the Lipase reagent OSR6x30 from Olympus
  393. Recall for PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, Roche
  394. Corrective action for the S3 Fluid Packs and S2 Fluid Packs (transponder defect), Roche…
  395. Urgent Field Safety Notice for HemosIL ReadiPlasTin by Instrumentation Laboratory Co.
  396. Safety Notice for MOSAIQ, IMPAC
  397. Lot recall of OXOID IDEIA Lyme Neuroborreliosis, OXOID Ltd./Thermo Fisher Scientific
  398. Safety Notice regarding Integra Cerebro Spinal Fluid management devices / Instructions for…
  399. Urgent Field Safety Notice for Azurion R2.0 by Philips Medical Systems Nederland B.V.
  400. Corrective action for the Dimension Vista System V-Lyte Integrated Multisensor from Dade…
  401. Lot recall of OSOM BVBLUE Test, Sekisui Diagnostics
  402. EXCOR Cannula
  403. Atellica IM 1300
  404. Recall of the Dimension clinical chemistry system Total triiodothyronine (T3) Flex reagent…
  405. Recall of the Pioneer Catheter model TA-XP-001 from Medtronic
  406. Recall for Biatin-Ibu Non-Adhesive Foam Dressing, Coloplast
  407. Corrective action for the Cell-Dyn 1800 System, Cell-Dyn 22 Calibrator, Cell-Dyn 22…
  408. Recall of the Wallaby III Femoral Components, Zimmer
  409. Urgent Field Safety Notice for syngo.via by Siemens Healthcare GmbH, SYNGO (SY)
  410. Recall for QuickGene, FUJIFILM
  411. Urgent Safety Notice for the Sonialvision Safire 17 Radiographic System, SHIMADZU…
  412. Trilogy Evo,Trilogy Evo O2,Trilogy EV300
  413. Artis zeego & Artis zee/Q./Q.zen
  414. FemoSeal Vascular Closure System
  415. Recall of Excia hip endoprothesis, Aesculap
  416. Recall for Medtronic Adjustable Valve, Medtronic Attain Access Left Heart Delivery System…
  417. Corrective action for Trugene HIV-1 GuideLines Rules 12.0 and 11.0, Siemens
  418. Recall of a genitourinary support system (AdVance Male Sling System), AMS
  419. Corrective action for the Cell-Dyn 22 Calibrator and Cell-Dyn 22 Control from Abbott
  420. Recall for Safety-Lancet, Sarstedt
  421. Recall of the wheelchairs Invacare Action², Invacare/Aquatec
  422. Safety Notice concerning the radiotherapy planning software XiO, Elekta CMS Software
  423. Urgent Safety Notice for Digital Linear Accelerators of type MEVATRON™ and PRIMUS™ with…
  424. Hamilton Medical AG: Corrective action for the Hamilton Medical lnfant Flow Sensor, single…
  425. Urgent Field Safety Notice for Empty bags in PVC by MacoPharma S.A.
  426. bb4ccf97-6118-ed3f-2413-c1fe0a6a84fe
  427. Information concerning the BrainSCAN version 5.2 or higher from BrainLAB
  428. Recall for Cleartest Troponin I, Servoprax
  429. Lot Recall of the Paediatric Arterial Cannula, MAQUET Cardiopulmonary
  430. Urgent Safety Notice concerning the disposable breathing circuit Ref. Nr. 270.743, WILAmed
  431. Corrective action for the CARESCAPE™ Monitor B850, B650 or B450, GE Healthcare
  432. Information for Image Diagnost MammoWorkstations, GE Healthcare
  433. Corrective action on certain Puritan Bennett 840 ventilators containing a particular power…
  434. Field safety notice concerning a possible risk in using connection fixture 1002.65A0 and…
  435. Recall for the AEROtube CSS1-1800-U1, CPAP-Universal-Tubing-System, HUM GmbH
  436. Alerta sanitaria sobre: SISTEMA DE REVISION DE RODILLA LINK Y SU INSTRUMENTAL ASOCIADO
  437. Recall for Genesis II C/R Femoral Size 8 Right, Smith & Nephew
  438. Urgent Field Safety Notice for newbio pk TPHA 2000 by Newmarket Laboratories Ltd.
  439. Corrective action and recall of the Architect cSystems (software versions 2.10, 2.11…
  440. Recall for defined series nos. of Dialog+, Diapact CRRT and Plasmat Futura, B. Braun…
  441. Safety Notice for Toppen 77, RPG Group
  442. Information concerning the e.motion and Columbus Femural Components from Aesculap
  443. Corrective Action/Recall for Sensors for Seronorm Trace Elements Serum Level 2, SERO
  444. Safety Information for the Metha Modular Short Hip Endoprosthesis, Aesculap AG
  445. Safety Notice for implantable cardioverter defibrillators Concerto and Virtuoso, Medtronic
  446. Raucodrape Surgical Incise Drape (55 x 80 cm, sterile), Lohmann & Rauscher GmbH & Co. KG
  447. Lot recall of Cell Saver Elite disposable processing kit / CS Elite FastPack, Haemonetics…
  448. Information concerning the Spectra Optia apheresis system from Gambro
  449. Corrective action for Milestone “Wand STA” Hand Piece, Milestone Scientific Inc.
  450. Risks when using the povidon-iodine containing MiniCap/OptiCap disconnect caps from Baxter
  451. Safety Notice for AMICUS MCN separator, Fenwal
  452. Recall for VCare uterine manipulators, ConMed
  453. Lot recall of Rythmic Spike Set PN DEHP Free, Micrel Medical Devices S.A.
  454. Safety Notice for Seno Advantage Workstation 1.x, GE Healthcare
  455. Corrective action concerning the STERRAD® 100S sterilization process of Anspach products…
  456. Urgent Safety Notice for the CADD®-Solis Ambulatory Infusion Pumps, Smiths Medical ASD
  457. Recall of the Access Immunoassay Systems Thyroglobulin Antibody Reagent Kit from Beckman…
  458. Lot Recall for Langston Dual-Lumen Pigtail Catheter, Vascular Solutions
  459. Corrective action for the Kodak DirectView DR 9000 System, Carestream Health, Inc.
  460. Recall of the single use mechanical lithotriptor, Olympus
  461. Urgent Field Safety Notice for HbA1c HIT917 by invicon diagnostic concepts GmbH
  462. AQT90 FLEX Analyzers
  463. Urgent Field Safety Notice for EMPOWR 3D Knee System & EMPOWR P.S. Knee System by Encore…
  464. Information for Prismaflex, Gambro Lundia
  465. Recall of the Airox ventilator systems Supportair, Smartair ST, Smartair Plus and…
  466. Information for Capture-R Ready-Screen Strips, IMMUCOR
  467. Urgent Safety Information for Trabecular Metal Humeral and Trabecular Metal Reverse…
  468. Urgent Field Safety Notice for CEREC AC OMNICAM / Connect by Sirona Dental Systems GmbH
  469. Problems with the Neonatal Ventilator Baylog 8000plus from Dräger
  470. Corrective action for the Integra® LED Battery Charger, Single Bay, Integra LifeSciences…
  471. Urgent Field Safety Notice for DeepUnity PACSonWEB by DH Healthcare GmbH
  472. Safety Notice for Spinnaker™ Elite™ Flow Directed Microcatheter, Boston Scientific
  473. Lot recall of various sports medicine and trauma products, ZIMMER BIOMET
  474. Problem with Ultrasound scanner Aplio and Xario from Toshiba
  475. Safety Notice for Fixation Posts - Leksell Stereotactic System® including Leksell Gamma…
  476. Corrective action for the CMF Drill Bit with Stop, Synthes GmbH
  477. Safety Notice concerning power wheelchairs Xeno, Otto Bock HealthCare GmbH
  478. Synthes GmbH: Corrective action/Recall for the Cortex Screw, self-tapping, length 8 mm Ø…
  479. Recall of Wallaby III revision tibial insert D-14, constrainde, Zimmer
  480. Safety Information for the product Trabecular Metal Dental Implant, ZIMMER DENTAL Inc.
  481. Recall of different High Pressure Lines from Smith Medical
  482. Recall of the locking Screws from Stryker
  483. Urgent Field Safety Notice for JETSTREAM XC and JETSTREAM SC Atherectomy Catheter by…
  484. Urgent Field Safety Notice for CGM CLINICAL Medication by CompuGroup Medical Deutschland…
  485. Urgent Field Safety Notice for ENAcombi (ORG 514) by Orgentec Diagnostika GmbH
  486. Corrective action for the Expo32 ADC Software Version 1.1 C from Beckman Coulter
  487. Safety Notice for Senographe DS and Senographe Essential Mammography systems, GE…
  488. Safety Notice for Spectra Optia Apheresis System, Terumo BCT
  489. Corrective action of Abbott Medisense for Precision Xtra and Precision Xtra OK glucometers
  490. Recall for EL-Cups, OHST Medizintechnik AG
  491. Safety Notice concerning use of Brainlab Scull Reference Base in combination with KLS…
  492. Corrective action for the product "PLATON Verriegelungsnagel", tantum AG
  493. Safety Notice for Navigation Software Cranial/ENT in combination with microscope…

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