Orca1

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International device safety notices

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Every International safety notice record published by Orca1, 1000 per page. Each page lists the record id and its name; open a record for key facts, related records and what Orca1 adds.

  1. Corrective action for the Pre-Loaded Barricaid® Delivery Tool, Intrinsic Therapeutics Inc.
  2. Urgent field safety notice for HemoCue Hb 201 DM Analyzer / Glucose 201 DM Analyzer /…
  3. ExacTrac Dynamic
  4. Update of the User Manual of the Zoll M-Series defibrillators from Zoll Medical
  5. Safety Notice for Masimo’s uSpO2 and HPLP Oximetry Cables, Masimo Corporation
  6. Urgent Field Safety Notice for ADVIA Centaur NT-proBNP and Atellica IM NT-proBNP…
  7. Urgent Safety Notice for the ACROBAT 2000 spring arms, Ondal Medical Systems GmbH
  8. Recall of the Convoy™ Advances Delivery Sheath Kits
  9. Safety Notice for AXIOM Aristos FX Plus Systems, Siemens Healthcare
  10. Recall for the Medicina Silo Dressing, Medicina Ltd.
  11. Jet-Ventilationskatheter nach Ravussin
  12. Safety Notice for Infinity Docking Station, Dräger
  13. Recall for Gold Probe™ Single-Use Bipolar Electrohemostasis Catheter, Boston Scientific
  14. Urgent Field Safety Notice for Harmonic ACE Curved Shears Insert by Intuitive Surgical…
  15. Field Safety Notice concerning increased leakage radiation from CT /e and HiSpeed X/I…
  16. Urgent Safety Notice for the Duowire™ guidewire, Coloplast
  17. Recall for Medicina Keyhole Dressing KDXX, Medicina Ltd.
  18. Urgent Field Safety Notice for Elekta Unity by Elekta Ltd
  19. Urgent Field Safety Notice for FTD Respiratory pathogens 21 by Fast-Track Diagnostics…
  20. Safety Notice for Alaris GP Volumetric Pumps and Alaris GP Guardrails Volumetric Pumps…
  21. Lot recall of ACUVUE OASYS contact lens, Johnson & Johnson Vision Care
  22. Lot recall for TLC Self-Retraining Retractor System, Applied Medical Technology Inc. /…
  23. Recall for Intran Plus IUPC trays, Utah Medical
  24. Safety Notice for the XGEO GC80, GC80V 80 und GC80V 65 X-ray systems, Samsung
  25. Important Safety Notice for the Digital Linear Accelerators, Elekta
  26. Batch recall of Hydrophilic Acrylic Single Use IOL system packs, Rayner lntraocular Lenses…
  27. Urgent Field Safety Notice for CLUNGENE COVID-19 Antigen Rapid Test by Hangzhou Clongene…
  28. Problems with Cair Wave 7303, Bi-Wave Carer 5202 and Viaclin 2503 from Pegasus
  29. Recall for HA Hip Stem, Stryker
  30. Urgent Safety Notice for Centricity PACS Web Diagnostic Software, GE Healthcare
  31. Urgent Safety Notice for the B•R•A•H•M•S NSE KRYPTOR, BRAHMS GmbH / Thermofisher…
  32. Urgent Field Safety Notice for Enzymatic Creatinine Rgt, Advia, Atellica, Dimension…
  33. Neuro Zti EVO, Neuro Zti CLA
  34. Porges recalls the Foley Latex catheter
  35. Field safety notice regarding Vector TAS Modular Driver, ORMCO
  36. Recall of Zimmer Persona Cemented Tibial Broach Inserter/Extractor Handles, Zimmer, Inc.
  37. Recall of the Slidex Meningitis Kit 5 from BioMérieux
  38. Recall of Bi-Polar-Heads
  39. Lot Recall for the Hedstroem root canal file, HAGER & MEISINGER
  40. Urgent Field Safety Notice for Elecsys Troponin T hs / Elecsys Troponin T hs S.A. by Roche…
  41. Recall for IMMULITE 2000/2500 Digital Fluidics PC Board, Siemens
  42. Corrective action for the Ebb Complete Tamponade System, Clinical Innovations
  43. Recall of XIA 3 Anti Torque key, catalog number 48237026, Stryker Spine Bordeaux
  44. Recall of Proceed Surgical Mesh from Ethicon
  45. Failure with Auto Delete function on GEMINI TF 16 and 64 PET/CT Systems, Philips
  46. Information about the AQUARIUS Haemofiltration machine from Edwards Lifesciences
  47. Recall for Ribbon Gauze with Vaseline 2cm x 10m and Clauden Wadding 5g, Lohmann & Rauscher
  48. Recall/Corrective Action for Coulter HmX and HmX AL Hematology Analyzers and for Coulter…
  49. Batch recall of Red Cell Disposables, Haemonetics
  50. Corrective action for Advia Chemistry Systems Advia 1200 and Advia 1650, Siemens
  51. Urgent field safety notice for VITROS Chemistry Products Na+ Slides, Ortho-Clinical…
  52. Safety Notice for Centricity PACS RA1000 Workstation, GE Healthcare
  53. Corrective action for Total IgE on Immulite® 1000, Immulite® 2000 and Immulite® 2000 XPi…
  54. Urgent field safety notice for HeartWare HVAD Controller Software, AC Adapter and Battery…
  55. Recall of Siemens Healthcare Diagnostics Diagnostics (Thermofisher) for Dade Lipid Control…
  56. Field safety notice concerning Lifeguard trolleys (stretchers) LG20 (all variants) and…
  57. Information for handholds delivered by Rolko, Hill Rom
  58. Safety Notice/Recall for the Bard Lifestent Vascular Stent System, Angiomed
  59. Corrective action for the NCL-L-CD15 (Novocastra™ Liquid Mouse Monoclonal Antibody), Leica…
  60. Urgent Field Safety Notice for ARIETTA 60 & 70 series, Hitachi Aloka Medical Ltd.
  61. Corrective action for RAPIDLyte Arterial Blood Sampling 3 ml Line Draw Syringes, Siemens
  62. Urgent field safety notice for TRACOE vario REF 464 - Tracheostomy Tube - fenestrated with…
  63. Additional Field Safety Notice for ARCHITECT Active-B12, Abbott
  64. Urgent Field Safety Notice for All Linacs with COHERENCE ONCOLOGIST RT* by Siemens…
  65. Field Safety Notice regarding SERVO-I and SERVO-s ventilators, Maquet
  66. Follow-up Information for IMMULITE/IMMULITE 1000 Androstenedione, Siemens Healthcare…
  67. Urgent Safety Notice for the Neurostimulation devices InterStim®, InterStim® II, Itrel®3…
  68. Urgent Field Safety Notice for Da Vinci Xi and X Conductive Reducer Tip by Intuitive…
  69. Information for the cleaning of the Revolution catheter securement device from Merit
  70. Corrective action for the product Carestream Health (CS 8100 und CS 8100 3D), Carestream…
  71. Lot recall for Klarsichtbeutel mit & ohne Falte / Klarsichtschlauch mit & ohne Falte…
  72. Smiths Medical recalls Portex 4.0 mm Uncuffed Blue Line Tracheostomy Tubes
  73. Corrective action for IMx Sirolimus from Abbott
  74. Recall Unimax Visible Trocar, Unimax
  75. Urgent Safety Notice for the Philips HeartStart MRx Monitor/Defibrillators, Philips…
  76. Missing wax plugs in the Microbiology Brushes from Boston Scientific
  77. Recall for Cholangioscopy Access Balloon, Cook Ireland Limited
  78. Safety Notice for Infusion pump A707V / A708V, CODAN ARGUS AG
  79. Urgent field safety notice for ETEST (various), bioMérieux
  80. Urgent Field Safety Notice for Philips Azurion system by Philips Medical Systems Nederland…
  81. Urgent Field Safety Notice for Philips Allura Xper, Allura Centron and Azurion by Philips…
  82. Recall of Roche for Tina-quant
  83. Recall of the 1,9 French ZeroTip Nitinol Stone Retrieval Baskets from Boston Scientific
  84. Information about Prismaflex Continuous Renal Replacement System from Gambro Lundia AB
  85. Recall for MixMate 5353, Eppendorf AG
  86. Urgent Field Safety Notice for cobas b 123, Roche Diagnostics GmbH
  87. Urgent Field Safety Notice for Irrasflow ICCU 020 Behandlungseinheit by IRRAS AB Inc.
  88. Information from Siemens Medical Solution of risks of softpot parameter
  89. Urgent Safety Notice for the LCS knee system with HP-instruments, DePuy
  90. Urgent field safety notice for Brain Metastases version 1.0.0 and Adaptive Hybrid Surgery…
  91. Information for MAGNETOM mobile systems, Siemens
  92. Safety Notice: Incorrect FlexMaps on XVI, Elekta
  93. Urgent Field Safety Notice for TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia…
  94. Safety Notice for Ascendra 2 Delivery System - Loader Assembly, Edwards Lifesciences
  95. Urgent field safety notice for guide wire J6-FC-160-063 / sterile, EPflex Feinwerktechnik…
  96. Batch recall for BacT/ALERT Culture bottles, bioMérieux Inc.
  97. Urgent Field Safety Notice for Actim RSV by Oy Medix Biochemica Ab
  98. Recall of Working Elements for Resectoscopes (Art. No.: WA22066A, WA22067A, WA22366A…
  99. Recall of two additional lots of Coseal Surgical Sealant, Baxter
  100. Safety Notice for the FUJIFILM Digital Mammography System Amulet with Biopsy unit…
  101. Lot recall of Extraction Screw for PFNA Blade, DePuy Synthes / Synthes GmbH
  102. Urgent Field Safety Notice for Volista by MAQUET SAS
  103. Urgent Field Safety Notice for Right coronal rod bender & Left coronal rod bender by…
  104. Corrective action for the Philips IntelliVue Information Center (PIIC) iX, Philips…
  105. Recall of guiding wires item no. 1311130, ANGIOKARD Medizintechnik GmbH
  106. Urgent Field Safety Notice for ADVIA Centaur by Siemens Healthcare Diagnostics Inc…
  107. Corrective Action: LATITUDE® Batch Printed Presenting EGMs, BOSTON SCIENTIFIC
  108. Urgent Safety Information concerning Remote controls for JUPITER, ARTIS and TruSystem 7500…
  109. Urgent Field Safety Notice for Barostim neo System, CVRx Inc.
  110. Corrective action for Lynoamp® BC, Lynoamp® BC HTS and Lynoamp® CC, Sysmex
  111. Important corrective action for 96 DEEPWELL PLATE 2ML on VERSANT kPCR Sample Preparation…
  112. Important corrective action for ADVIA Centaur / Centaur XP / Centaur XPT / Centaur CP /…
  113. Recall of Wallstent Endoscopic Biliary Endoprosthesis with Unistep Plus Delivery System…
  114. Lot recall Platon Nails / bone nails, TANTUM
  115. Urgent Field Safety Notice for Specify 5-6-5 Surgical Lead and Specify 2x8 Surgical Lead…
  116. Safety Notice for the Medtronic Mosaic™ Porcine Aortic Bioprosthesis, Medtronic Inc.
  117. Field Safety Notice concerning Ingenuity CT systems with specific serial numbers, Philips
  118. Recall Immulite C-Peptide-Assays, Siemens
  119. Revised instruction for use concerning nursing bed Scanbed 400, Invacare
  120. Corrective action for 3.7 mm D and 4.1 mm D Trabecular Metal implants, Zimmer Dental
  121. Field Safety Notice concerning SKYLight Spect Systems, Philips
  122. Baxter recalls infusion extension sets
  123. Corrective action for the SONY LMD-1951MD monitors, Sony Corporation
  124. Urgent field safety notice for sterile Inspire Custom Pack Revision 02, Cardiac Surgery BU…
  125. Urgent Field Safety Notice for Radrex-i (Canon) by Canon Medical Systems Corporation
  126. Recall of Biermann for the Immulite 2000 Testosteron Assay
  127. Urgent Field Safety Notice for Syramed µSP6000 by Arcomed AG
  128. Extended corrective actions for Kodak 2100 and Kodak 2200 Intraoral X-ray systems…
  129. Corrective action for PF4 Enhanced, PF4 IgG or PF4 Concentrated Wash, Immucor GTI…
  130. Corrective action and recall for Coulter LH 700 und Gen•S Haematology analyzers, Beckman
  131. Safety Notice for Quatrix acrylic intraocular lens with a preloaded injector, Croma
  132. Recall for Diagnostic Discs FOX10 Cefoxitin, Oxoid
  133. Urgent field safety notice for UniCel DxH 600 / 800 Coulter Cellular Analysis System…
  134. Urgent Field Safety Notice for Ingenuity TF PET/CT by PHILIPS MEDICAL SYSTEMS (Cleveland)…
  135. Recall for Check-Flo Performer Introducer Sets, Cook Medical
  136. Urgent Field Safety Notice for AXIOM Artis by Siemens AG / Healthcare Sector / Business…
  137. Corrective action for Access Immunoassay Systems enhanced AccuTnI Reagent Kit for use on…
  138. Urgent Safety Notice for the extension device (“Raumextensionsgerät”), Lautenschläger
  139. Problems with the HDI 4000 Ultrasound Imaging system from Philips
  140. Urgent Safety Notice for the Philip’s Anesthesia Machines, DAMECA A/S / Philips Healthcare
  141. Batch recall for enteral syringe Freka Connect ENLock 5 ml, Fresenius Kabi Deutschland…
  142. Urgent Field Safety Notice for SwishTapered Implant / SwishPlus Implant by Implant Direct…
  143. Accurus Standalone Vitreous Probe Paks
  144. Advisory notice on the Genius 75 dialysis machine from Fresenius
  145. Information for Flexi-Seal, ConvaTec
  146. Expanded Safety Notice for the product Berman Angiography catheter, Arrow International
  147. Batch recall of BEAVER 4.0 mm Banana Blade, Smith & Nephew Inc.
  148. Lot Recall of the device PROPHYflex, KAVO DENTAL
  149. Information for Clinic Information Center (CIC), GE Healthcare
  150. Safety Notice for Gendex GXCB-500, KaVo
  151. Corrective action for Vitros® Chemistry Products White Correction Factor Slides, Ortho…
  152. Urgent Field Safety Notice for Discovery NM 630, Optima NM/CT 640, Discovery NM/CT 670 DR…
  153. Recall of Laparoscopic BiClamp handles, ERBE Elektromedizin GmbH
  154. Safety Notice for F1 Dental Chair, FIMET OY
  155. Urgent Safety Notice: Potential for electric shock when servicing the XRMW or XRMB…
  156. Safety Notice for the Precision 500D, Precision MPI and Precision RXI X-ray imaging…
  157. Urgent Field Safety Notice for CombiDiagnost by Philips Medical Systems DMC GmbH
  158. Safety Notice for Carina home, Home Care Ventilator, Dräger Medical
  159. Recall for Access Immunoassay Systems Free T3 Calibrators, Beckman Coulter
  160. Urgent Field Safety Notice for ImmunoCAP Specific IgG/IgG4 i1 Control H, ImmunoDiagnostics…
  161. Urgent Field Safety Notice for Immunanalyse-Gerät VIDAS/ miniVIDAS by bioMérieux S…
  162. Recall CELL-DYN, Abbott
  163. Lot Recall for Oxygen Masks and Face Tent Masks, Unomedical
  164. Safety Notice for the ADEPT® Hip Resurfacing System (Finsbury Orthopaedics Ltd.), DePuy
  165. Urgent Field Safety Notice for CombiDiagnost by Philips Medical Systems DMC GmbH
  166. Boston Scientific recalls ANTHEOR™ Temporary Vena Cava Filter
  167. Recall of Afinion CRP, Axis-Shield
  168. Advisory notice from Wright Cremascoli Ortho for ROFEMUR C/D hip implant
  169. Lot Recall for PMMA IOL model 645A, Rayner
  170. Recall: Various Sterile-Packaged Femoral Heads and Tapers, Zimmer
  171. Corrective action for Venosafe SP and SAS tubes,Terumo
  172. Recall for ACCUPROBE Group B Streptococcus kit, ACCUPROBE Mycobacterium tuberculosis…
  173. Recall for the Midface Distractor, Synthes GmbH
  174. Urgent Safety Notice for the BIRMINGHAM HIP™ Resurfacing System (BHR), Smith & Nephew…
  175. Urgent Safety Notice for VISX™ STAR™ excimer laser chair, Advanced Medical Optics
  176. Corrective action for the Brainlab Offset Cup Impactor Universal, Brainlab AG
  177. Safety Notice concerning refilling of implantable drug pumps, Medtronic
  178. Corrective action for the COLLEAGUE Pump, Baxter
  179. Corrective action for the Biolox Delta Ceramic Head 28mm Standard Neck, Biomet UK Ltd.
  180. Safety Notice for Pneumo Sure XL High Flow Insufflators, Stryker
  181. Recall of Beaver Mini-Blades from Becton Dickinson
  182. Safety Notice for the BD Plastipak™ 50ml Luer Lok Syringes with Syringe Pumps, Becton…
  183. Corrective action for the RAPIDLab® and RAPIDPoint® Systems, Siemens Healthcare…
  184. Safety Notice for the patient lifts Liko Uno, Liko Light, Viking S and Viking XS, Liko AB
  185. Potential defect of the AC/draw/return manifold of Trima Accel Disposable Tubing Sets…
  186. Recall of Adaptateur pour Flacon Isopack, Baxter Healthcare
  187. Urgent Field Safety Notice for HEMOSPRAY ENDOSCOPIC HEMOSTAT by Cook Endoscopy
  188. Corrective action for BBL Staphyloslide Latex Test Kit, Becton Dickinson
  189. Urgent Safety Notice for the product CD138 PE, Becton, Dickinson and Company
  190. Lot recall of EcoPort compact F8, A.M.I. Agency for Medical Innovations GmbH / A.M.I…
  191. Corrective action for the Terumo Two-Parts Syringe - Occasional Appearance of Lubricant…
  192. COOK recalls Song Nasolacrimal Duct Stent sets
  193. Urgent customer information of Pierre Fabre Dermo Cosmetique concerning Ducray Itax lotion…
  194. Lot Recall for CLEAR-TRAC FLEXIBLE Reusable Obturators, Smith & Nephew Inc.
  195. Urgent Safety Notice for the ACUSON S2000 Automated Breast Volume Scanner (ABVS), Siemens…
  196. Fisher & Paykel recalls respirator tubes for children
  197. Recall of the spreader bars of the personal lift Invacare Flamingo
  198. Recall of CERTAIN EP Healing Abutmen from 3I IMPLANT INNOVATIONS
  199. Recall Triage Micro C. Difficile Panel, BIOSITE
  200. Urgent Safety Notice for Codmann® Disposable Drill Kits, Codmann & Shurtleff Inc.
  201. Safety Notice for Alaris® PK Syringe Pump, Cardinal Health
  202. Urgent Safety Notice for the product S4 Dynamic Rod, AESCULAP AG
  203. Safety Notice for the ACUSON SC2000 ultrasound system, Siemens Medical Solutions USA…
  204. Safety Notice for the Peristeen Anal Irrigation System, Coloplast
  205. Recall for the 48mm Multi-Loc Screw, Synthes GmbH
  206. Safety Notice for storage screen systems with software version ADC QS 2.1.xx, AGFA
  207. Risk of a framework fracture with the combination of the add-on drives e-fix or e-motion…
  208. Information for Ferno Scoop model 65 EXL
  209. Urgent Field Safety Notice for Trilogy100 / Trilogy200 / Garbin / Garbin Plus / TrilogyO2…
  210. NeuMoDx HIV-1 Quant Test Strips
  211. PRAC meeting highlights 7-10 June 2022
  212. Thera - treatment table
  213. B. subtilis Inhibitor plate MiQ
  214. Change Healthcare Radiology Solutions
  215. Field Safety Notice regarding the COstatus AV Loop, Transonic Systems
  216. Urgent Safety Notice for the AIRO Mobile CT Scanner, Mobius Imaging, LLC
  217. Urgent Field Safety Notice for Nellix (Version 3.5), Endovascular Aneurysm Sealing System…
  218. Urgent Field Safety Notice for Alef, Til, Conix by Medical Systems and Devices…
  219. Safety Notice concerning Coronary Analysis Software V1.10 of Scenaria device, Hitachi…
  220. Corrective action for bioNexia FOBplus, bioMérieux
  221. Urgent Safety Information for Atriasept II ASD&PFO Devices, Cardia
  222. Recall of Triage 8 Panel for Drugs of Abuse Test Kit, Alere San Diego
  223. Safety update of the treadmills firmware, h-p-cosmos
  224. Recall for Bladder Irrigation Connectors, Miniuro Connectors and Irrigation Sets for…
  225. Urgent field safety notice for defibrillator FRED easy, SCHILLER MEDICAL SAS
  226. Baxter: Recall for the products INTERMATE FILLING SET, Vented spike with Clearlink…
  227. Safety Notice for Dental EZ-J-Chair, TGA Weber
  228. Corrective action for Philip’s Anesthesia Machines, Philips Healthcare - Anesthesia Care…
  229. Urgent field safety notice for iChemVELOCITY Urine Chemistry Strips, Beckman Coulter /…
  230. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
  231. INNOTEST HIV Ag mAb
  232. Safety Notice concerning the LapLoop System, OPTEC
  233. Visine Ophthalmics recalls the products Visine Tired Eyes Sensitive, Visine Tired Eyes and…
  234. Information for Corpuls 3 defibrillator, GS Elektromedizinische Geräte
  235. Lot recall of SurefuserPlus, Nipro Europe NV
  236. Safety Notice for AXIOM Artis and Artis zee, Siemens
  237. Safety Notice for GXR Systems with SCP Generator and tube grid switch functionality…
  238. Safety Notice for AXIOM Artis systems regarding Quantification Software, Siemens
  239. Corrective action for Oxoid Antimicrobial Susceptibility Testing Disc VA30 Vancomycin…
  240. Recall for Navilyst Xcela™ PICC w/PASV, BioFlo PICC w/ Endexo and PASV, Navilyst Medical
  241. Expanded Recall for Zoll R Series Defibrillator, Zoll
  242. Lot recall of Inhibin A ELISA Kits (Ref.: DSL-10-28100-4, DSL-10-28100T-4), Beckman…
  243. Safety Notice for the cardiovascular X-ray imaging systems Innova, GE Healthcare
  244. Urgent Field Safety Notice for Basissets mit Papp-Nierenschalen by Smiths Medical ASD…
  245. Information from Baxter for the pain management system Ipump
  246. Recall of one batch of the product M-flex intraocular lens, Rayner
  247. Safety Notice for the Wound-EL Dressing Electrode 15x15cm (10x10cm), Mölnlycke Health Care
  248. Urgent Field Safety Notice for POCKIT Central Nucleic Acid Analyzer by GeneReach…
  249. Problems with the Pain Management Systems Ipump and PCA-II Infusion Pump from Baxter
  250. Recall of some tube covers and camera drapes from Mölnlycke Health Care
  251. Updated surgical technique and instructions for use for the Zimmer® Segmental System…
  252. Recall for the product Shuntassistent, CHRISTOPH MIETHKE GMBH & CO. KG
  253. Recall for TestPack+Plus hCGCombo with OBC, Unipath
  254. Problem with TrueBeam und TrueBeam STx, Varian medical systems
  255. Urgent Safety Notice for NAVIOS™ Flow Cytometer, Beckman Coulter
  256. Urgent Safety Notice for the Philips BrightView SPECT, BrightView X and BrightView XCT…
  257. Problem with the Endrys Coaxial Transseptal Left Heart Access Needle with the Mullins…
  258. Safety Notice for X-ray systems OEC 7600 and OEC 7700, GE Healthcare
  259. Problem with the LIFPACK 12 defibrillator from Medtronic
  260. Full lot recall of Natural-Knee II Durasul All-Poly Patella, Zimmer
  261. Urgent field safety notice for Monaco, IMPAC Medical Systems Inc. / Elekta AB
  262. Information for the proper positioning of the Reliant® Stent Graft Balloon Catheter and…
  263. Information for Cystatin C FS, DiaSys Diagnostics Systems
  264. Corrective action for the Persona (TASP) Tibial Articular Surface Provisional Shim, Zimmer…
  265. Urgent Field Safety Notice for Cryptococcal Antigen Lateral Flow Assay by…
  266. Urgent Field Safety Notice for Rheumatoid Factor Kit for use on SPAPLUS by The Binding…
  267. Urgent Field Safety Notice for Procedure Trays containing Insufflation Tubing Set with Gas…
  268. Safety Notice/Corrective action for Single Limb Circuit for Pneupac® Ventilators with PEEP…
  269. Lot recall of LoFric Nelaton 20 cm CH10 urinary bladder catheters for single use, Astra…
  270. Urgent Field Safety Notice for Atellica CH Immunoglobulin M_2 (IgM_2) by Siemens…
  271. Recall for Expanding polyvinyl alcohol (PVA) sinus tampons, SPIGGLE & THEIS
  272. Recall for endotracheal (ET) tubes, Unomedical
  273. Safety Notice for MultiPlan® Treatment Planning System Version 3.5, Accuray
  274. Lot recall of custom specific procedure trays containing Urine Drainage Bags by Unomedical…
  275. Urgent Safety Notice for the Oral Fluid Drug Screen Device Saliva, SureScreen Diagnostics…
  276. Recall for the Stryker System 6 Aseptic Housings, Stryker Instruments
  277. Urgent field safety notice for kPCR SAMPLE PREP SUB-SYSTEM 96 DEEPWELL PLATE 2 ML, Siemens…
  278. Urgent Field Safety Notice for Suprasorb A+Ag Antimicrobial Ca-Alginate Dressing by…
  279. HeartStart MRx defibrillators from Philips may deliver the specified energy
  280. Lot recall of Acetabular Reamer 44 mm, catalogue number 2102-0444, Stryker
  281. Lot Recall of Compoglass F, IVOCLAR VIVADENT
  282. Urgent field safety notice for DuraDiagnost and DuraDiagnost Compact x-ray system, Philips…
  283. Safety Notice for the phaco needle wrench of the phaco packs, Bausch & Lomb
  284. Software update for Brilliance CT Big Bore required, Philips
  285. Corrective action for the ISKD - Intramedullary Skeletal Kinetic Distractor (Limb…
  286. Correction of eye-applicators from BEBIG
  287. Urgent Safety Notice for the ACUSON 802000™ ultrasound systems, Siemens
  288. Recall of Tracheotomy Tubes from Unomedical
  289. Recall for Large-Bore Central Venous Catheters, Arrow International
  290. Urgent Field Safety Notice for Arrow PICC, Epiduralkatheter, Abdecktuch, Nadel für…
  291. Recall of the Air Optix (O2 Optix) soft contact lenses from CIBA Vision
  292. Information for MX4000, MX4000 Dual and MX6000 Dual, Philips
  293. Urgent field safety notice for AFX Endovascular AAA System / recall of small remaining…
  294. Urgent Field Safety Notice for Polyaxial Screw; Size Ø4.0x26 mm by Stryker Spine - K2M…
  295. Information for Mevatron, Primus Plus and Oncor Impression, Siemens
  296. Recall for Hematology Reagent C Eosin Stain, Wescor Inc.
  297. Lot Recall for procedure trays containing Urine Drainage Bags by Unomedical A/S, Paul…
  298. Urgent Field Safety Notice for SIGMA HP PFJ Cemented Trochlear Implants. by DePuy…
  299. Recall of accessory driving and breaking systems for wheelchairs from Alber
  300. Information for Multi RX, Multi SX, Fluoroscope 20 and Fluoroscope 90, Toshiba
  301. Safety Information for the device 2450® Electrosurgical Generator, ConMed Electrosurgery
  302. Urgent Field Safety Notice for Chirurgisches Notfallset Berlin für C-Problem by S. Us…
  303. Integra NeuroSciences recalls LICOX® C8.B
  304. Safety Notice for the MRP-TITAN and the KAM-Titan instruments, Peter Brehm GmbH
  305. Recall Syva Emit® II Plus, Dade Behring
  306. Lot Recall for Level 1 Disposable Normothermic IV Administration Sets, Smiths Medical
  307. Second Recall for Fem-Flex II Femoral Access Cannulae, Edwards Lifesciences
  308. Recall of Polystan safe Micro Oxygenators
  309. Recall for CD 103 PE and CD 103 FITC reagents, Becton Dickinson
  310. Recall of ablation catheters from CryoCath
  311. VOCO recalls Rebilda composits
  312. Information about the BD Careflow™ Central Venous Catheter from Becton Dickinson
  313. Warning from DePuy International for Duraloc / Duraloc Option components
  314. Recall CarFlex, TMP Tüshaus Medical Produkte
  315. Another Safety Notice for the ACUSON SC2000, Siemens
  316. Safety Notice for LightSpeed VCT 7.2 Vision and Discovery CT750 HD Computed Tomography…
  317. Urgent Field Safety Notice for COATED VICRYL PLUS SUTURE by Johnson & Johnson…
  318. Information concerning the safe use of infusion sets when used in volumetric infusion…
  319. Software-Update of the treadmills of the PPS Series, Woodway GmbH
  320. Safety Notice for MR Eclipse 1.5T RF Connector Block, Philips
  321. Recall of the product Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter, Bard…
  322. Urgent Safety Notice for the DR unit “DX-D 600 with semi-automatic configuration”, Agfa…
  323. Recall of endoscope controllers da Vinci Xi Surgical System, Intuitive Surgical Sàrl
  324. Safety Notice for Oncentra Visir, Nucletron B.V.
  325. Maintenance instructions for the mobile hoist Victor with scale, type 3000 N2 from…
  326. Urgent Field Safety Notice for HAMILTON-C1/ -C2/ -C3/ -C6 Ventilator unit by Hamilton…
  327. Corrective action of Roche for Integra HbA1c
  328. Corrective action for Total Bilirubin OSR of Olympus
  329. Safety Information for the products Self-Righting Luer Slip and Luer Lock Tip Caps, Baxter…
  330. Corrective action of Biotest for Tango analyzer
  331. Recall of Pentapharm for battery packs of Dell notebooks
  332. Recall of combination disks cefpodoxime/clavulanate, Oxoid
  333. Information for DI-Series Administration Sets indicated for use with the Level 1® Fast…
  334. Urgent Field Safety Notice for EliA SmDp Well, Art. No. 14-5624-01, Phadia AB / Thermo…
  335. Safety Notice for PowerHeart AED G3, Cardiac Science Corp.
  336. Safety issue with Operating Table TITAN, Trumpf Medizin Systeme GmbH
  337. Corrective Action for Analyzers ABL505/555, EML105, ABL600, ABL700 Series, ABL800FLEX and…
  338. Recall of the product AMO TECNIS iTec Preloaded Delivery System, Abbott Medical Optics…
  339. ORTHO VISION Max Analyzer
  340. Recall GMRS Proximal Femoral Surgical Protocol, Stryker
  341. Field safety notice concerning a problem in Eclipse Version 10 with ARIAtm Radiation…
  342. Urgent Safety Notice for the Zimmer Trabecular Metal™ Reverse Shoulder System Glenosphere…
  343. Information for Zenith® Flex AAA Endovascular Graft, Cook Medical
  344. Safety Notice for Revitan Disassembly Instruments, Zimmer
  345. Recall for the product i-Visc 1.4, i-Medical Ophthalmic International GmbH
  346. Recall of Zimmer Persona Tibial Articular Surface Inserters, Zimmer, Inc.
  347. Recall for IntraStent®, Ev3 Inc.
  348. Advisory Notice of the firm Becton Dickinson about BD MultiVisc Viscoadaptive Solutions
  349. Urgent Field Safety Notice for Oxoid M.I.C.E Meropenem MA0121 by Thermo Fisher Scientific…
  350. Aesculap recalls polyaxial screws
  351. Corrective action for the Biolox Delta Ceramic Head 36 mm, Biomet UK Ltd.
  352. Safety Notice for Philips iSite PACS 4.1, Philips Healthcare
  353. Recall of the "Laser beam guide, standard, single-use" and "Ophthalmic fiberoptic light…
  354. Safety Notice for EasyDiagnost Eleva, Philips
  355. Urgent Field Safety Notice for Eleganza 5 by Linet spol. S..o.
  356. Urgent Safety Notice for the Puristeril® 340 GENIUS® canister, Fresenius Medical Care GmbH
  357. Recall of catheters from Becton Dickinson
  358. Urgent Field Safety Notice for Verticale Pedikelschraube by Silony Medical GmbH
  359. Urgent Field Safety Notice for MIC Gastrostomy Tube Care Kit 16 by Avanos Medical Inc
  360. Corrective action for the Harmonic ACE Curved Shears Instructions for Use (IFU), Intuitive…
  361. Urgent Field Safety Notice for VeriQ Systems, VeriQ C Systems, MiraQ Systems by Medistim…
  362. Safety Notice for Carescape Monitor B650 and B850, GE Healthcare Finland Oy
  363. Safety Notice for the devices Cyto-Set Infusomat Space, Cyto-Set Mix and Cyto-Set Infusion…
  364. Urgent Field Safety Notice for Entuit Secure Gastrointestinal Suture Anchor Set by Cook…
  365. Recall for monitor component of the LifeVest system, Zoll Lifecor
  366. Lot Recall for Coseal Surgical Sealant, Baxter
  367. Urgent Field Safety Notice for therascreen RAS Extension Pyro Kit, - GIST RapidScreen Pyro…
  368. Corrective action of the clinical chemistry system Dimension RxL Max with STM from Dade…
  369. Urgent Field Safety Notice for Precedence BrightView X BrightView SPECT BrightVie by…
  370. Recall of the Syva Emit 2000 Phenobarbital test from Dade Behring
  371. Field Safety Notice concerning the system board of Hewlett-Packard model rp5700 PC’s sold…
  372. Recall of the Impulse Angiographic-Catheter from Boston Scientific
  373. Urgent Field Safety Notice for ADVIA Centaur DHEA-S, ADVIA Centaur HBc IGM, ADVIA Centaur…
  374. Recall SmarTemp Temperature Probe covers, Shenzhen Mindray Bio-Medical Elektronics
  375. Urgent Field Safety Notice for DxI 9000 Access Immunoassay Analyzer by Beckman Coulter…
  376. Recall Megasystem-C, Waldemar Link
  377. Recall of numerous lots of T2 Arthrodesis Nail, STRYKER
  378. Macrolane
  379. Strips for the VIDAS® series analyzer for the qualitative determination of total…
  380. d2bf320a-2ad5-7ac9-0af4-42f3bf984674
  381. Recall for the radial head prosthesis MoPyC, Tornier SAS
  382. DUET TRS Loading units (SOLU) devices not to use in thoracic surgery, Covidien
  383. Recall of the ConMed Linvatech Hall Burs from ConMed Linvatech
  384. Recall of Radial Head Prosthesis System, DePuy Synthes / Synthes GmbH
  385. Information for GE Centricity Enterprise Web-Versions, GE-Healthcare
  386. Field safety notice concerning safety issues relevant for Xeleris Workstation 1.0, 1.1…
  387. Urgent Field Safety Notice for Eurotrol Hemoglobin Controls by Eurotrol B.V.
  388. Safety Notice for Physio-Control LIFEPAK® 20 Test, Medtronic
  389. Recall for the EasySpray Pressure Regulator, Tissomat and DuploSpray MIS Pressure, Baxter
  390. Recall of Kodak Flexible Phosphor Screens
  391. Recall burs, Stryker
  392. Recall for Promos Standard Inclination Sets, Smith&Nephew
  393. Safety Notice for Philips Essenta RC, Philips and Neusoft Medical
  394. Urgent field safety notice for iChemVELOCITY Automated Urine Chemistry System using…
  395. Safety Notice for Healthcare beds, Völker AG
  396. Urgent Field Safety Notice for SINGLE USE MONOPOLAR CABLE by PETERS SURGICAL
  397. Urgent Field Safety Notice for Cerebrospinal fluid shunt valve by Christoph Miethke GmbH &…
  398. Inditherm Medical has issued an information concerning a recall of the electrically heated…
  399. Safety Notice for the product syngo Dynamics with Sensis integration licence, Siemens…
  400. Urgent field safety notice for Dimension clinical chemistry system / Dimension Vista…
  401. Recall of plastic needle with mandarin, Varian Medical Systems
  402. Urgent Field Safety Notice for Monopolare Schere IN CUT; Monopolare Pinzette ENDOGRIP…
  403. Abbott Alinity m SARS-CoV-2 AMP Kit, m Resp-4-Plex AMP Kit - UUENDATUD parandused ülekande…
  404. Recall orthodontic wire, Highland Metals
  405. Recall of Bard Composix Kugel Patches Large
  406. Safety Notice for ProcedurePak, Mölnlycke
  407. Corrective action CELL-DYN Sapphire Hemoglobin Reagent Syringes, Abbott
  408. Recall for certain Hydrophilic Acrylic Single Use Intraocular Lens system packs, Rayner…
  409. Corrective action of BEP 2000 / BEP 2000 Advance System, Dade Behring
  410. Urgent field safety notice for AP Cutting Block Triathlon / Scorpio, Stryker / Spierings…
  411. Urgent Field Safety Notice for BARD Site~Rite 8 Ultrasound System by Bard Access Systems…
  412. Corrective action of the Treatment Planning Systems Eclipse from Varian
  413. Information for Epic, Atlas and Convert, St. Jude Medical
  414. Recall for Moltech/Accutronics battery, Covidien
  415. Urgent Field Safety Notice for Artis one by Siemens Shenzhen Magnetic Resonance Ltd.
  416. Safety Notice for the SIEMENS AXIOM Vertix MD Trauma systems, Siemens AG
  417. Urgent Safety Notice for the product Digital Linear Accelerator, Elekta Limited
  418. Recall FACSDiva™ Software v 6.0 and 6.1, Becton Dickinson
  419. Recall for Jamshidi-Needles of the XIA Precision-Systems, Stryker Spine Bordeaux
  420. Recall of HeartStart FR2+ Automated External Defibrillators, models M3860A, M3861A, M3840A…
  421. Recall for HLS-Cannulae BE-PVL 2955, Maquet
  422. Medtronic recalls Talent AAA Stent Grafts
  423. Safety Notice for COLLEAGUE Single Channel and Triple Channel Volumetric Infusion Pumps…
  424. Corrective action for Artis one Systems, Siemens Shenzhen Magnetic Resonance Ltd.
  425. Urgent field safety notice for CytoSorb 300 ml, CytoSorbents Inc.
  426. Lot recall of Devon Light Glove, Medtronic
  427. Urgent Field Safety Notice for 1.5T SIGNA HDxt, SIGNA Architect, SIGNA Pioneer, SIGNA…
  428. Recall of Weicon soft contact lenses from Ciba Vision
  429. Safety Notice for Symbia® S- and T-Systems with Automatic Collimator Changer, Siemens
  430. Safety Notice for GE Centricity PACS Web Diagnostic Software-Version 3.7.3, GE Healthcare
  431. Recall of several batches of the products Propano AF® and esteer® SEPT, Esteer Pharma GmbH
  432. Recall of Weicon 38E contact lenses from Ciba Vision
  433. Corrective action for Freestyle Lite test strips, axicorp Pharma GmbH
  434. Urgent Safety Notice for DigitalDiagnost systems Release 4.0.0 and 4.0.1, Philips Medical…
  435. Recall of the VOYAGER RX Coronary Dilation Catheter from Guidant
  436. Recall for Variokone Adapter, Biomet
  437. Recall for the product Cannulated screw 7.5, aap Implantate AG
  438. Corrective action for BD FACS 7-Color Setup Beads, Becton Dickinson
  439. Urgent Safety Notice concerning the airspa Blower, Meditechnik GmbH
  440. Recall Osmocoll SS-025, SS-038 and SS-039, Wescor
  441. Update of guide addendum for HomeChoice Automated PD System and HomeChoice PRO Automated…
  442. Recall Fire Star™ and Dura Star™, Cordis
  443. Recall for Triathlon Primary Cemented Baseplate, Stryker
  444. Supplement to the Corrective Action for the syringes of BEP III, Siemens
  445. Urgent field safety notice for ED-3490TK Video Duodenoscope, PENTAX Europe GmbH
  446. Urgent field safety notice for STERRAD NX Sterilization System, Ethicon Inc. / Johnson &…
  447. Recall ACL Workstation Slider, Stryker
  448. Batch recall of Connectable Radio-Opaque Pushers, Coloplast
  449. Safety Notice concerning the Puritan Bennett 840 ventilator and Puritan Bennett 700 series…
  450. Corrective action for syringe pumps type Module DPS from Fresenius
  451. Recall for "Intraocular Lens Xcelens IDEA 613XC", Xcelens
  452. Recall for Feeding Kits containing a grasping snare, Bard Access Systems
  453. Safety Notice for Video-Duodenoscope TJF-Q180V, Olympus
  454. Urgent Field Safety Notice for OP-Sets mit OP-Mänteln by Biocon Medizintechnik GmbH
  455. Change in the Instructions for Use of the ASICO Royal Unihand Injectors
  456. No use of RAUMEDIC NEUROVENT-catheters in combination with HP M1006 pressure modules
  457. Recall of particular lot numbers of the Duisburg Needle, Teleflex Medical
  458. Urgent Field Safety Notice for Programmiergerät 3200 S-ICD by Cardiac Pacemaker Inc.- A…
  459. Urgent Field Safety Notice for PLUS S. MIA DBL OFFSET ADAPT. RT 60/25MM by Smith & Nephew…
  460. Battery depletion of the ICD Marquis, InSync and Maximo from Medtronic
  461. Recall of Bipolar Forceps from Tyco Healthcare
  462. Recall of SLIDEX Staph-Kit, bioMerieux
  463. Corrective action for Oxoid Legionella BCYE Growth Supplement, Thermo Fisher Scientific…
  464. Urgent Field Safety Notice for APAAP mouse Monoclonal, Dako
  465. Urgent Field Safety Notice for Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia…
  466. International Technidyne Corporation recalls the blood lancets Tenderlett Adult Finger…
  467. Corrective action of the i-STAT PT/INR-cartridges from Abbott
  468. Corrective action for ABL90 Flex, Radiometer
  469. Corrective action for NCL-L-CD15 (Novocastra™ Liquid Mouse Monoclonal Antibody), Leica…
  470. Urgent Field Safety Notice for IMMULITE 2000/IMMULITE 2000 XPi EBV-VCA IgM by Siemens…
  471. Information for Centricity PACS RA1000 Workstation, GE Healthcare
  472. Recall for the Gamma Probe Cover, Microtek Medical Inc.
  473. Recall for Novy Cornual Cannulation Set, Cook
  474. Safety Notice for Cominox Sterilclave 6B Speedy, ROOS Dental
  475. Urgent Safety Notice for the balanSys® Knee System, Mathys
  476. Urgent Field Safety Notice for SEKUSEPT Pulver by Ecolab Deutschland GmbH
  477. Safety Notice for Sterrad 50 Sterilizer, Johnson & Johnson
  478. Recall for Oxidase Identification Sticks, OXOID Ltd. /Thermo Fisher Scientific
  479. Olympus Diagnostica recalls C-Reactive Protein
  480. Recall for the product Competence Flow, Willmann & Pein
  481. Information for cone adapter, ESKA
  482. Corrective Action for UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800…
  483. Recall of the Ultraview SL Command Module with Masimo SpO2 Option, Model 91496-M from…
  484. Corrective action and recall of the Sample Management System (software version 2.2) from…
  485. Corrective action of the Powerheart G5 Automatic External Defibrillators (AEDs), Cardiac…
  486. Varian Medical Systems recalls Tongue and Soft Tissue Kits
  487. Corrective action of the Troponin I-test from Ultimed
  488. Urgent Field Safety Notice for ACE Trochanteric Nail (ATN) System by Biomet Orthopedics…
  489. Urgent Safety Notice for the products "Instrumente mit flexiblen Wellen", Mathys AG…
  490. Aesculap recalls the FG317R SOCON reduction instruments
  491. Recall of the Durasul Alpha Insert Box from Zimmer

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