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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 Navigation Software Cranial/ENT in combination with microscope…
  2. Corrective action for BacT/Alert systems from bioMérieux
  3. Corrective action of Becton Dickinson for BD Logic glucometers
  4. Information regarding Mitroflow Model 12, LXA and DL, Sorin Group Canada, Inc.
  5. Urgent Field Safety Notice for Atellica COAG 360 by Siemens Healthcare Diagnostics…
  6. Recall for ARCHITECT Tacrolimus Reagent, Abbott
  7. Urgent field safety notice for ACQUITY UPLC Sample Organizer IVD, Waters
  8. Urgent Field Safety Notice for syngo.via by Siemens Healthcare GmbH, SYNGO (SY)
  9. Corrective action of Roche for Elecsys Troponin T
  10. Information for the iE33 Ultrasound System in combination with the S121-4 transducer from…
  11. Corrective Action for ARCHITECT iVancomycin Reagent, Abbott
  12. Recall for HARTMANN CombiSets containing Ring Basin Liner, PAUL HARTMANN AG
  13. Corrective action for the products VIVA II, PRISMA II and MELODY II (Sleep apnea devices)…
  14. Urgent Field Safety Notice for Thermo ScientificTM OxoidTM Mueller-Hinton Broth by Thermo…
  15. Recall for B12 Flex reagent cartridges, Siemens
  16. Exchange of all Nihon Kohden QI-403P Interface
  17. Safety Notice for Babylux range, Maquet
  18. Additional Information for Medstream Implantable Drug Infusion Pump, Codman
  19. Recall for meditrol Troponin I MCHE170, Medichem Vertriebs GmbH
  20. Urgent Safety Notice for the Delta Motion Acetabular Implant, DePuy
  21. Corrective action for the Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and…
  22. MediTrade informs about the distribution of fakes
  23. Recall for Troponin I Test kits with rapid tests, HK Diagnostika
  24. Recall for several products because of a packaging error, Angiotech
  25. Safety Notice / Refitting for Entroy pool lifters, Arjo Hospital Equipment AB
  26. Recal of one lot of PE tibial inserts of the VKS Knee Endoprosthesis from Plus Orthopedics
  27. Safety Notice for syngo Workflow MLR, Siemens
  28. Safety Notice for the Terumo® Advanced Perfusion System 1, Terumo
  29. Urgent Field Safety Notice for Thermo Scientific Oxoid Brilliance Salmonella A by Thermo…
  30. Safety Notice for LATITUDE in-home communicators, Boston Scientific
  31. Software revision of the OptiVantage™ Injectors from Tyco Healthcare
  32. Corrective action for Immulite / Immulite 1000 Total T4, Dade Behring
  33. Recall for BD CD10 products, Becton Dickinson
  34. Urgent field safety notice for ARTIS pheno systems, Siemens Healthcare GmbH
  35. Fisher & Paykel recalls the dual heated breathing circuits
  36. Recall of inner tubes of the prosthetic foot models Re-Flex VPS and Low Profile Re-Flex…
  37. Safety Notice for VARIS LINK, Varian Medical Systems
  38. Venous Line Clamp Occlusion Failure on hemodialysis instruments SYSTEM 1000, TINA, AURORA…
  39. Corrective action or the N Latex HCY (OPAX03) Assay on the BN™ II System from Dade Behring
  40. Safety Notice for Etac Supportbelt / Etac Immedia Supportbelt A/S / Immedia A/S…
  41. Safety Notice for the PTFE Ventilation Tubes, Spiggle & Theis Medizintechnik GmbH
  42. Recall of the Powerlink with Visiflex infrarenal bifurcated delivery System from ENDOLOGIX
  43. Safety Notice for AMPLATZER® Cardiac Plug, AGA Medical Corporation
  44. Urgent Field Safety Notice for Cios Alpha by Siemens Healthcare GmbH, X-Ray Products (XP)
  45. Important Safety Notice for ADT inbound interface to MOSAIQ or Multi-ACCESS, Elekta IMPAC…
  46. Recall for Covidien Devon™ Light Glove included in CeMed procedure packs, CeMed GmbH
  47. Urgent Field Safety Notice for Sebond Implant by Schütz Dental GmbH
  48. Urgent Field Safety Notice for Elisa Trolley by Löwenstein Medical GmbH & Co. KG
  49. Information for Compat Go and Compat Go Plus pumps, Nestlé Healthcare Nutrition
  50. Urgent Field Safety Notice for GPS Wire / Guide Wire by FUJIFILM medwork GmbH
  51. Recall of the Fusion OMNI ERCP Catheter from Cook Endoscopy
  52. Recall for Uniglide Unicondylar Knee System and Zenith Total Ankle System, Corin Ltd.
  53. Field Safety Notice concerning a problem with OMRIX Pressure Regulator to administer…
  54. Corrective action for the the Radioimmunoassay Coat-A-Count Direct Androstenedione…
  55. Recall for IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2500 and IMMULITE Control…
  56. Recall for AU5800 Clinical Chemistry Analyzer, Beckman Coulter
  57. Urgent Field Safety Notice for PALUTOP +4 OPTIMA by BIOSYNEX
  58. Corrective Action for SYNCHRON Systems Phenobarbital (PHE) Reagent, Beckman Coulter
  59. Urgent Field Safety Notice for schwarzer evo by Schwarzer Cardiotek GmbH
  60. Medical Device Alert, MHRA
  61. Corrective action for the Waterlase iPlus Dental Laser System (Software version 1.7)…
  62. Urgent Safety Notice for Medtronic Navigation Cannulated Taps, Medtronic Navigation Inc.
  63. Recall for C5L PLATELET SET (5-DAY STORAGE), Fresenius
  64. Urgent Field Safety Notice for EVIS EXERA DUODENOVIDEOSCOPE TJF-145 by Olympus Medical…
  65. Corrective action and recall of the Dimension Clinical Chemistry System (software version…
  66. Stop of Delivery of the Metha Implant Components by Aesculap
  67. Safety Information for hospital bed model Avanta, Joh. Stiegelmeyer GmbH & Co. KG
  68. Urgent field safety notice for Allura Xper x-ray systems, Philips
  69. Safety Notice for ACUSON X300, ACUSON and SONOLINE Antares, ACUSON S2000, Siemens Medical…
  70. Recall of NexStent™ Monorail™ Carotid Stent systems, Boston Scientific
  71. Recall of the HemoCue Glucose 201 RT System from HemoCue
  72. Safety Notice for Custom Paks, Alcon
  73. Recall for Target Coils, Stryker Neurovascular
  74. Urgent Safety Notice for Leica Peloris™ Rapid Tissue Processor, Leica Biosystems Newcastle…
  75. Urgent Field Safety Notice for Liquid Cardiac Control by Randox Laboratories Ltd
  76. Urgent Field Safety Notice for Sensor Nitinol Guidewires with Hydrophylic Tip by Boston…
  77. Recall of the Level 1 Normothermic I. V. Fluid Administration Set from Smiths Medical
  78. Corrective action for analyzers of the ABL700 series and ABL800 Flex from Radiometer
  79. Safety Notice for TrueBeam and TrueBeam STx, Varian medical systems
  80. Safety Notice for syngo Imaging XS in combination with „JPEG Compression” license, Siemens
  81. Urgent Field Safety Notice for Eschweiler combiline/Eschweiler modularPro by Eschweiler…
  82. Model 1000 SenTiva® VNS Therapy® Generators (S/N < 100000)
  83. Small Electric Drive
  84. STERRAD Model: 100S, 50, 200, NX, 100NX
  85. Systems for use with infusion pumps: Infusomat® Space Line SafeSet IV System (Cat. No…
  86. Ostenil (viscoelastic solution for joint treatment)
  87. NexGen Complete Solution MIS Total Knee Procedure
  88. Hepatitis B virus core total antibody IVD, control
  89. Recall of several catalog numbers of Scorpio NRG 4:1 cutting blocks, Stryker Orthopaedics
  90. Safety Notice for Digital Accelerators with Electrons and Beam Modulator, MLCi/MLCi2…
  91. Recall for Nitinol guide wire, OptiMed
  92. Lot recall of Optilene 8/0 (0,4) 60 cm 2XDR8, Aesculap AG
  93. Safety Notice for PCR Eleva, Philips
  94. Batch recall of DOLPHIN inflation device, PEROUSE MEDICAL / Vygon
  95. Recall for insufflation device CO2 flow, ulrich GmbH & Co. KG
  96. Urgent Field Safety Notice for PROBE Titanschale 60 mm links Lasche 60 mm by PETER BREHM…
  97. Lot recall of Arthroscopy Outflow/Suction Tubing Sets, ConMed Linvatec Corporation
  98. Urgent Field Safety Notice for Epoca Revision Set by Synthes GmbH
  99. Exatech recalls the Optetrak Cemented Finned Tibial Trays
  100. Recall for Software Chip of da Vinci S, Intuitive Surgical
  101. Recall for the Aquamantis 2.3 Bipolar Sealer, Salient Surgical Technologies
  102. Recall for Bone marrow aspiration / biopsy puncture needle, trocar 3,00 mm, OptiMed
  103. Corrective Action for LabPro V4.11 Software, Siemens
  104. Urgent Field Safety Notice for Oxoid _ PO1186A Thermo ScientificT Brilliance Staph 24 Agar…
  105. Additional Information: Lot Recall of different dialysis tubing systems, Gambro
  106. Urgent Field Safety Notice for Yankauer Suction Tubing, Penrose Tubing, Trocar Catheter…
  107. Activated Alanine Aminotransferase (A-ALT)
  108. Safety Notice for SynchroMed II, Medtronic
  109. Recall of the power supply DT50 manufactured by Friwo and which is used with the Pari Sole…
  110. Urgent Field Safety Notice for Infinity Acute Care System (IACS) by Draeger Medical…
  111. Recall for certain sterile packages of OP-sets / individual sets, MaiMed GmbH
  112. Corrective action for the IgG T on Integra 700/800 analyzers from Roche
  113. Safety Notice concerning BrainLAB-Navigation Software Knee Essential 2.1.1 Zimmer…
  114. Urgent Field Safety Notice for Procedure trays: Bandscheiben Tray KH Vilsbiburg Spinale…
  115. Safety Notice for Radiographic System Floating Tabletop, GE Healthcare
  116. Corrective action for PRISMA and PRISMAFLEX sets, Gambro Industries
  117. Urgent Safety Notice - Silimed Implants, SILIMED - lndustria de lmplantes Ltda
  118. CareLink SmartSync Device Manager
  119. Recall for Vacuum Pumps Metal, B. & W. Schmidt
  120. Urgent Field Safety Notice for Phagenyx by Phagenesis Ltd.
  121. Urgent Field Safety Notice for Blood Collection Systems and Filters by Haemonetics…
  122. Recall for Troponin I and CardiaCombo Myoglobin/CK-MB/Troponin I, Rolf Greiner BioChemica
  123. Safety Notice for Planning Software iPlan Stereotaxy 3.0, Brainlab
  124. Recall of two lots of the Search Evolution Uni Knee Endoprosthesis from Aesculap
  125. Recall for SKATER Single Step und Choice Lock TCD products, Angiotech-PBN Medicals
  126. Urgent field safety notice for Halo / Lil Angel Halo Vest, Össur
  127. Information concerning the update of the Galileo ventilator from Hamilton
  128. Safety Notice for Zeus anaesthesia machine, Dräger
  129. Safety Notice for Philips Intellivue Clinical Information Portfolio Releases D.03, E.0 und…
  130. Corrective action of Varian High Energy and Low Energy Clinacs from Varian Medical Systems
  131. Safety Notice for the oxygen concentrator model Permox and Permox SilentCare, Dräger…
  132. Urgent Safety Notice for the Guide Wire Ø 3.2 mm, length 400 mm, Synthes GmbH
  133. Urgent Field Safety Notice for Becton Dickinson Syringes by Becton Dickinson France S.A.S.
  134. Recall for BA721 SKIN-GRFT CARRF/BA720R1:1.5STER, Aesculap
  135. Recall for ABL700 Series Calibration 1 Solution S1720, Radiometer
  136. Safety Notice concerning pushing and braking aid movilino, AAT Alber Antriebstechnik
  137. Corrective action and recall for the MicroScan LabPro Information Manager System from Dade…
  138. c8dc9815-89a0-0bc9-082e-91374efac12d
  139. Recall for Octopus Nuvo Tissue Stabilizer, Medtronic
  140. Urgent field safety notice for Acrobat 2000 spring arms, MAQUET Vertrieb und Service…
  141. Corrective action for the Camino® Intracranial Pressure Monitoring Catheter, Integra…
  142. Safety Notice for the Confidence Side Fire Needle, DEPUY
  143. Urgent Field Safety Notice for NexSys by Haemonetics Corporation
  144. Urgent Field Safety Notice for Venner PneuXP.Y Endotracheal tube (Non-MRI) by Venner…
  145. Recall of the central venous catheter Kids Cath NEO from Rüger Medical
  146. Information for Orthobiom Spinal System, PARADIGM SPINE
  147. Recall for the Juggerknot System, BIOMET
  148. Recall of different venous catheters and introducers with antimicrobial coating, Arrow…
  149. Corrective action for the diagnostic ultrasound system ProSound F75, Hitachi Aloka…
  150. Urgent field safety notice for EP-TRACER, CardioTek B.V.
  151. Recall for the Mucolexx / Mucolytic Agent, Richard Allan Scientific
  152. Corrective action for the Hudson RCI® SHERIDAN SHER-I-BRONCH® Endobronchial Tube, Teleflex…
  153. Safety Notice for the Encore, Chorus and Sara Plus Standing and Raising Aids, Arjo…
  154. Recall of the Vasofix cannulae 1,1 x 33 mm, 20G from B. Braun
  155. Safety Notice for Essenta DR Compact, Philips
  156. Recall of procedure packs / kits with Beacon Tip angiography catheter, Cook Medical Europe
  157. Recall for SenSura® and Assura® colostomy bags, Coloplast
  158. Safety Notice concerning a malfunction when using syngo.plaza with an archive license…
  159. Recall for the Raucodrape Surgical Incise Drape, CeMed GmbH
  160. Software update for the VIP Gold/Sterling ventilators from Viasys
  161. Safety Notice for Aisys anaesthesia machine, GE Healthcare
  162. Recall of Frazier and Poole Suction Instruments from ConMed
  163. Urgent Field Safety Notice for VIKIA Malaria Ag Pf/Pan by bioMérieux S. (Marcy- l'Etoile)
  164. Recall of the lot number 264516 of the cleaning solution Bodedex forte from Bode Chemie
  165. Recall for the Coroflex Isar Coronary stent, B. Braun Melsungen AG, Division Aesculap…
  166. Safety information regarding malfunction of Novalung Vision alpha, Novalung GmbH
  167. Recall of the product LeGoo Endovascular Occlusion Gel, Genzyme Corporation (Sanofi)
  168. Corrective action for the IntelliVue MX40 patient monitor with software revisions B.00 and…
  169. Safety Notice for Prometheus CiCa, Fresenius Medical Care
  170. Urgent Safety Notice for the Digital Radiography X-Ray System DX-D 100, Agfa HealthCare NV
  171. Urgent Field Safety Notice for S. AIA-PACK ACTH by Tosoh Corporation
  172. Urgent Field Safety Notice for Efficia External Paddles by Philips Goldway (Shenzhen)…
  173. Corrective action for CellQuest Pro Software, Becton Dickinson
  174. Important Safety Notice for microSelectron and Flexitron afterloaders, Nucletron B.V.
  175. Urgent Field Safety Notice for Geistlich Bio-Oss Pen by Geistlich Pharma AG
  176. Corrective action and recall for BD Multiset Software (versions 2.1, 2.11 and 2.2) from…
  177. Second Notice for Weck Hem-o-lok Large Polymer Clips, Teleflex Medical
  178. Corrective action for Stair-PRO Stair Chair 6251 and 6252, Stryker
  179. Urgent Field Safety Notice for S. AIA-PACK Homocysteine by Tosoh Corporation
  180. Recall of certain connectors from Fisher & Paykel
  181. Recall of certain medical devices of the manufacturer Iramed GmbH, Mandel + Rupp GmbH
  182. Urgent Field Safety Notice for PRIMUS, ONCOR, ARTISTE by Siemens Healthcare GmbH, Advanced…
  183. Safety Notice concerning the correct use of Resolution II Clip, Boston Scientific
  184. Urgent Field Safety Notice for BD Phoenix PMIC/ID-69 panels by Becton, Dickinson and…
  185. Urgent Field Safety Notice for Amicus MNC-Apherese-Set by Fresenius Kabi Deutschland GmbH
  186. Safety Notice for Pulsera and Endura, Philips
  187. Urgent Field Safety Notice for VITEK 2: AST-N254 , AST-N330, AST-N371 test kits by…
  188. Information concerning the Tracheostomy Tube Holders 240 Blue and 242 Blue from DALE…
  189. Safety Notice for BV Pulsera and Endura, Philips
  190. Lot recall of specific lots of NexGen Complete Knee Solution Legacy Knee-Posterior…
  191. Urgent Field Safety Notice for Atellica Solution by Siemens Healthcare Diagnostics Inc…
  192. Information for Infusion Workstation Orchestra Base Primea, Fresenius Kabi
  193. Recall for Cleartest PSA, Servoprax
  194. Recall for the Complement reagent, Siemens
  195. Recall for the Osteotomy Guiding Device, DePuy Synthes
  196. Recall for gabControl PSA-Test, gabmed
  197. Corrective Action for Core TDM Multi-Calibrator, Part no.. ODC6411 (Lot no. 0021 and…
  198. Recall of the femoral cannulae from Sorin Group
  199. Recall of the Frazier & Poole Suction instruments from ConMed
  200. Recall for Access Total T4 Calibrators (Part no.: 33805, lot no.: 917074, 008534), Beckman…
  201. Urgent Field Safety Notice for SynCardia temporary Total Artificial Heart (TAH-t) by…
  202. Safety Notice for the Practix Convenio Mobile x-ray System, Philips Medical Systems
  203. Recall for Bordetella pertussis ELISA (EC115.00) IgA cut off control, Genzyme
  204. Urgent Field Safety Notice for Vanadis View Plate by Wallac Oy
  205. Safety Notice for SpineCath & Acutherm Catheters with Introducer Needles, Smith & Nephew
  206. Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics…
  207. Recall of Stephany Diagnostika for Secu-Troponin I
  208. Lot Recall for Coseal Surgical Sealant, BAXTER
  209. Urgent Field Safety Notice for Axiom Sensis by Siemens AG / Healthcare Sector / Business…
  210. Information for ETI-AB-HAVK PLUS, DiaSorin
  211. Safety Notice for the EDT 3 plus washer/disinfector, Olympus
  212. Urgent field safety notice for LenSx Laser with Corneal Flap Capability, Alcon Pharma GmbH
  213. Recall for Resolution Clips, Boston Scientific
  214. Field Safety Notice concerning BrightSpeed Excel/Edge/Elite Select and BrightSpeed Elite…
  215. Corrective Action for STA Satellite, Diagnostica Stago
  216. Mon-a-Therm™ Foley catheters with temperature sensors
  217. Corrective action for Dimension Vista System and StreamLAB Analytical Workcell, Siemens
  218. Field Safety Notice concerning BeneHeart D6 defibrillator / monitor, Shenzhen Mindray…
  219. Corrective Action/Recall for Amanitin ELISA, BÜHLMANN Laboratories AG
  220. Urgent field safety notice for Eclipse needle, BD Medical
  221. Lot recall of Hygro-c Inserter, privelop-spine AG
  222. Information for Kaye Posture Control Walker, Quest
  223. Safety Notice for Vital Signs Monitor, Spacelabs Medical
  224. Urgent Field Safety Notice for Olympus Diego Elite High speed drill burrs by Olympus…
  225. Recall of Architect Free T3 from Abbott
  226. Corrective action for XE-Series Haematology Analyzers from Sysmex
  227. Urgent Safety Notice about the stop of using all Neptune Waste Management Systems in…
  228. Field Safety Notice concerning Infant Incubator Dual Incu i, Atom Medical
  229. Recall of the BCI Autocorr Patientmonitors from Smiths Medical
  230. Recall for Endo Femoral Aimers, Smith & Nephew
  231. Lot Recall for the elastomeric infusion pump ON-Q with OnDemand bolus button, I-Flow
  232. Updated Safety Notice for Infinia nuclear medicine systems, VG and VG Hawkeye nuclear…
  233. Urgent Field Safety Notice for Atellica CH 930 Analyzer by Siemens Healthcare Diagnostics…
  234. Recall of the VKS® Tibial Trials from Plus Orthopedics
  235. Corrective action for Barco surgical displays, Barco
  236. Recall for Hemdiag Stuhltest, Ökonomed
  237. Recall of Durom Femoral Components, Zimmer
  238. Recall for Bipolar Forceps, Sutter Medizintechnik GmbH
  239. Urgent Field Safety Notice for Atellica Solution by Siemens Healthcare Diagnostics Inc…
  240. Recall of Preservation tibial trays from DePuy
  241. Urgent Field Safety Notice for EMR Manager (PACS) by Vepro AG
  242. Recall GEM 2753, Synovis
  243. Lot Recall for Habib Bipolar Resection Device, ANGIODYNAMICS
  244. Recall for TheraScreen K-RAS Mutation Kit, DxS Ltd. / Roche Diagnostics
  245. Urgent field safety notice for ACOR / INTEGRALE / OPTIMAL, AMPLITUDE
  246. Recall of the Slidex Meningitis Kit 5 from bioMérieux
  247. Safety Notice for syngo Workflow MLR, Siemens
  248. Corrective action for the ADVIA Centaur TnI-Ultra, Siemens Healthcare Diagnostics Inc.
  249. Urgent Field Safety Notice for Perfusor Space 12V-Anschlussleitung by B. Braun Melsungen…
  250. Recall of Preface Sheaths from Biosense Webster
  251. Information concerning the iPlan RT Image versions 2.0 or 3.0 from BrainLAB
  252. Safety Notice for MX4000, MX4000 Dual and MX6000 Dual, Philips
  253. Urgent Field Safety Notice for BD Vacutainer® Blood Collection Tubes by Becton Dickinson…
  254. Urgent Field Safety Notice for Care Plus 1000, 2000, 3000, 4000 by Datex-Ohmeda, Inc.
  255. Lot recall of implant driver Profile EV 4.2 long, DENTSPLY lmplants Manufacturing GmbH
  256. Urgent Field Safety Notice for Care Plus, Care Plus Model 1000, 2000, 3000 und 4000…
  257. Safety Notice/Software update for the ML-G insufflator, MGB
  258. Corrective Action / Follow-up Information for CA19-9 Flex reagent cartridges, Siemens
  259. Recall for the Custom Procedure trays (CPTs) containing the affected Basin Liner, ArcRoyal…
  260. Recall for Medi-Test-Combi 9, Macherey-Nagel
  261. Safety Information for the S4C Occiput Torque Wrench F/Set Screw, Aesculap AG
  262. Recall of Zelos PTA-balloon catheter, optimed GmbH
  263. Urgent Field Safety Notice for IBDoc, component: CalApp Reader (software) by Bühlmann…
  264. BD Plastipak Syringe, CT with Luer Slip Adaptor
  265. Belzer UW Cold Storage Solution
  266. Safety Notice for the product BRAHMS PCT direct, BRAHMS GmbH, part of Thermofisher…
  267. Urgent Field Safety Notice for FilmArray BCID kits (RFIT-ASY-0126 / RFIT-AST-0127)…
  268. Lot Recall of FLAMINGO-Inflations Devices, Perouse Medical
  269. Urgent field safety notice for eMAG nucleic acid extraction system, bioMérieux SA
  270. Recall for Pediatric/Neonatal Wire Attached ECG Electrodes, ConMed
  271. Safety Notice for the Philips Brilliance iCT and iCT SP
  272. Lot recall of TruCal HbA1c liquid, DiaSys Diagnostic Systems GmbH
  273. Recall for Surgical Heart Valves, Edwards Lifesciences
  274. Recall of CombiSets® containing Raucodrape incision foil, PAUL HARTMANN AG
  275. Lot recall of Surefuser, NIPRO MEDICAL EUROPE
  276. Lot recall of standard lag screw Omega 110 / 105 mm length, Stryker GmbH
  277. Corrective action for the product Centricity PACS-IW with Universal Viewer, GE Healthcare…
  278. Urgent field safety notice for battery packs used in Capnostream 20 and Capnostream 20p…
  279. Urgent Field Safety Notice for StageOne Select, Hip Cement Spacer Molds by Biomet…
  280. Information concerning the OBI versions 1.2 and 1.3 with CBCT from Varian
  281. Rückruf bestimmer Los-Nummern des Produktes Rotacrush, Medwork Medical products and…
  282. Corrective action for the Shaver Handpiece Sterilization Tray, Stryker Endoscopy
  283. Recall for childrens wheelchair Küschall K-Junior, Invacare-Aquatec
  284. Safety Notice for DICOM-Import for Oncentra Visir, Nucletron
  285. Recall for EasyCool 70G4, 80G4 and 90G4 Ablations Catheter, MedFact GmbH
  286. Recall for Palatal Implant, Straumann AG
  287. Information for Liberator, Low Loss Reservoir, Sprint, Stroller and Hi-Flow Stroller, MPS
  288. Urgent Field Safety Notice for 611 Ankle Fusion Nail Drill by TORNIER SAS
  289. QuickSuite
  290. Lot Recall for CooperSurgical Mystic II Vacuum Assisted Delivery Products, Cooper Surgical…
  291. Recall for V-Max® 6-Inch Beveled Bone Access Needle, DePuy
  292. Urgent Field Safety Notice for MICRO SCISSORS CVD.BL/SH 140MM by Aesculap AG
  293. Recall of the ELS - cannulae from Maquet
  294. Safety Notice for Bilirubin Total (AXON00115), Bilirubin Total (A11A01639) and Bilirubin…
  295. Urgent Field Safety Notice for Silk+ by BALT Extrusion
  296. Safety Notice for Mini C-arms OfficeMate and FSIII, Hologic
  297. Urgent Field Safety Notice for C-RAD Gating Box HZ-009. c4D Software by C-RAD Positioning…
  298. Urgent Field Safety Notice for Monoclonal Mouse, Anti-Pneumocystis J. & Anti Huma by Dako…
  299. Information for iPlan RT Dose versions 3.0, 3.0.1 and 3.0.2, BrainLAB
  300. Corrective action for the MatrixRIB™ Fixation System (T-Plate 2.0 mm), Synthes GmbH
  301. Corrective action for the Cutting Accessoires (used with Elite attachments), Stryker…
  302. Corrective action for the 5mm Thoracic Grasper, Intuitive Surgical
  303. Urgent field safety notice for EPIQ Ultrasound System, Philips Ultrasound
  304. Recall for Nephrostomy catheter, Coloplast
  305. Corrective action for the rollator TOPRO Troja 2G, TOPRO Industri AS
  306. Urgent Field Safety Notice for Alu CARLO Classic by Beka Hospitec GmbH
  307. Urgent Field Safety Notice for Detachable EndoRetrieval Pouch by Unimax Medical Systems…
  308. Safety Notice for Galileo Echo, Immucor
  309. Recall for the products Cardioxyl®, Cardioflon® Evolution und Surgikit®, Péters Surgical
  310. Recall of the infusion device Infudrop Air matic PY from Fresenius Kabi AG
  311. Urgent Field Safety Notice for Ultima Activator II Reusable Drive Mech by Maquet…
  312. Corrective action for the Olympia Stem size 2 Right, Biomet
  313. Urgent field safety notice for neuro | mate frameless gen II (USA) / neuro | mate…
  314. Recall of the Architect LH reagent from Abbott
  315. Recall for Nephrostomy Catheter Set, Teleflex Medical
  316. Recall of implantable left ventricular assist device systems HeartAssist 5 LVAS, MicroMed…
  317. Zimmer: Recall for specific lots of the NexGen Complete Knee Solution MIS Total Knee…
  318. Urgent Field Safety Notice for synedra AIM by Synedra Information Technologies GmbH
  319. DePuy ReClaim® Reamer Extension
  320. Inspection of the plug connection with the walker model TOPRO Troja from Handicare
  321. Replacement of power supplies of Olympic Cool-Cap system for head-cooling therapy of…
  322. Corrective action for the product Somatom Emotion 6 / 16, Siemens Shanghai Medical…
  323. Safety Notice for Revolution pump, Sorin Group
  324. Corrective action for the Curefab CS device, Curefab Technologies GmbH
  325. Recall/Corrective action or ACCELERATOR APS Centrifuge Module, Abbott
  326. Safety Notice for MR products, GE Medical Systems
  327. Urgent Field Safety Notice for ExcelsiusGPS by Globus Medical, Inc.
  328. Safety Information for the EP Shuttle Generator / EP Shuttle System 100W, Biosense Webster
  329. Urgent field safety notice for SynchroMed II implantable drug infusion pump, Medtronic
  330. Corrective action for Bard® Per-Q-Cath® products, Bard Access Systems (BAS)
  331. Extension of the Recall/Corrective action for StreamLAB Analytical Workcell - Hettich…
  332. Urgent Field Safety Notice for Esophageal/Rectal Temperature Probes by Philips Medical…
  333. Urgent Field Safety Notice for Cerebase DA Guide Sheath by Medos International SARL
  334. Corrective action for HemoCue Glucose 201 RT and HemoCue Glucose 201 DM RT, HemoCue
  335. Recall for Calcium reagent, Roche
  336. Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by…
  337. Urgent Field Safety Notice for ProteusPLUS, ProteusONE by IBA (Ion Beam Applications)
  338. Safety Notice for Bryan Cervical Disc System, Medtronic
  339. Safety Notice for Trium CTG Online, Trium Analysis Online GmbH
  340. Corrective action for the DuraDiagnost X-ray system, Philips Healthcare
  341. Corrective action for the BIRMINGHAM HIP™ RESURFACING (BHR) SYSTEM, Smith & Nephew
  342. Urgent field safety notice for AQUIOS CL Flow Cytometer, Beckman Coulter
  343. Lot recall of Lipopolysaccharide binding protein (LBP), Siemens Healthcare Diagnostics…
  344. Urgent Field Safety Notice for 5mm ENDOPATH XCEL Bladeless Trocars with Optiview…
  345. Potential screen-freeze on Olympic Cool-Cap system for head-cooling therapy of neonates…
  346. Urgent Field Safety Notice for Carag Bioresorbable Septal Occluder (CBSO) System by CARAG…
  347. Information for microspeed® uni mobile stand GA411, Aesculap
  348. Corrective action for the C-series High Energy Linear Accelerator, Varian Medical Systems
  349. Safety Notice for Ultraview SL 2200, 2400 and 2600 Monitore with Wireless-Option…
  350. Corrective action for the Oxoid Legionella BCYE Growth Supplement, Thermo Fisher…
  351. Corrective action for the ELI 380 electrocardiograph, Mortara Instrument, Inc.
  352. Urgent Field Safety Notice for SureForm Stapler by Intuitive Surgical, Inc.
  353. Recall for Vario-Fit Hüftendoprothesensystem, aap
  354. Lot recall of Medex Cardiothoracic Custom Sets, Smiths Medical International Ltd.
  355. Urgent Field Safety Notice for BONE MARROW ASPIRATION NEEDLE by Zamar
  356. Recall for Synex II Modular Vertebral Body Replacement System, Synthes
  357. Recall for BD Vacutainer Blood Collection Tubes, Becton Dickinson
  358. Recall for the Kimberly-Clark Custom Procedure Trays (CPT’s) containing the Microtek Basin…
  359. Urgent Field Safety Notice for Dismozon plus by BODE Chemie GmbH
  360. Information for OS Unicondylar Knee Application, Zimmer
  361. Recall for the Pertussis Toxin Elisa IgG Quantification-Set, Sekisui Virotech
  362. Urgent field safety notice for Stratus CS Acute Care CCRP TestPak, Siemens Healthcare…
  363. Urgent Field Safety Notice for Endwarts classic by Meda Pharma S.p.A.,
  364. Urgent Field Safety Notice for RayStation by RaySearch Laboratories AB
  365. Recall for BeeFill Pack, Aseptico
  366. Urgent Field Safety Notice for FilmArray Blood Culture Identification (BCID) Panel by…
  367. Safety Notice for Calcar Planar, Stryker
  368. Urgent Field Safety Notice for MCDh 1 by RAL DIAGNOSTICS
  369. Corrective action for PRISCA 5.0, Siemens
  370. Urgent Field Safety Notice for AMICA PROBE by HS Hospital Service S.p.A.
  371. Lot recall for IMMULITE 2500 HCG (L5KCG2,6), Siemens
  372. Urgent field safety notice for POLYMAILLE EXTRA THIN vascular prostheses, PEROUSE MEDICAL
  373. Urgent Field Safety Notice for by CERTEST BIOTEC SL
  374. Additional Information concerning the Recall for Roticulator Single Use Stapler, Covidien
  375. Recall for the SofPort & SoFlex intraocular lenses, Bausch + Lomb
  376. Recall for reagents ex-TEM, Pentapharm
  377. Safety Notice concerning a corrective action of the AC 250 ISC Varian Proton Therapy…
  378. Urgent Field Safety Notice for Alere NT-proBNP Control/Alere NT-proBNP Calibrator by…
  379. Urgent Field Safety Notice for Hemochron Microcoagulation System APTT Test Cuvettes…
  380. Urgent Field Safety Notice for Syva Emit II Plus 6-Acetylmorphine assay by Siemens…
  381. Urgent Field Safety Notice for CamAPS FX software by CamDiab Ltd
  382. Safety Notice for Corpuls3, GS Elektromedizinische Geräte G. Stemple GmbH
  383. Safety Notice for coDiagnostiX, Institut Straumann AG
  384. Information for Mobile Care-Software/Mobile Viewers L-WEB05 and iCentral L-NET05, GE…
  385. Urgent Field Safety Notice for Anchor Tissue Retrieval SystemT by ConMed Corporation
  386. Urgent Field Safety Notice for HemosIL Heparin by Instrumentation Laboratory Co.
  387. Corrective actions concerning the Dimension Articulated Stone Baskets from Bard
  388. Recall for BD™ Gram Crystal Violet 250 mL and BD™ Gram Stain Kit, Becton Dickinson
  389. Revised Safety Notice for the product NordiPen®, Novo Nordisk
  390. Corrective Action on Cold-Disinfection for THERMO SCIENTIFIC HM550-D, Microm International…
  391. Urgent Safety Notice for the Heart Reference Sensor (Model Number EVHRS) / ClearSight…
  392. Recall of one manufacturing lot of Procedure Pak called Ophthalmologie - Set I, Mölnlycke…
  393. Urgent Field Safety Notice for Alere Afinion 2 by Alere Technologies AS (vorher…
  394. Recall of one lot of the Transend EX™ Standard .014-Guidewires from Boston Scientific
  395. Problem with Optical Guidance Platform (OGP), Varian medical systems
  396. Safety Notice for Siregraph CF, Siemens
  397. Urgent Field Safety Notice for Navelsnodd / Cordring by Wing Plast AB
  398. Lot Recall for the VA-LCP Two-Column Distal Radius Plate, SYNTHES
  399. Recall for HMRS Distal Femur and HMRS Femoral Joint, Stryker
  400. Lot recall of Oxoid Antimicrobial Susceptibility Testing Disc ATM30, Oxoid
  401. SCHILLER CARDIOVIT AT-102 ECG - Priority 2 - Warning
  402. Recall for the Pasteur Pipets, Origio Inc.
  403. Urgent Field Safety Notice for Purified silicon oil by FCI S.A.S.
  404. Urgent Field Safety Notice for Incisive CT/MX 16 Slice by Philips Healthcare (Suzhou)…
  405. Urgent Field Safety Notice for Sterile Hypodermic Syringes for single Use by Hunan Pingan…
  406. Urgent Field Safety Notice for VERTICALE S. Schraubendreher Hülse by Silony Medical GmbH
  407. Recall of several batches of Biatain Ag Non-adhesive Foam Dressings, Coloplast
  408. Urgent Field Safety Notice for StoneBreaker® Pneumatic Lithotripter by Cook Urological…
  409. Field Safety Notice about CT syngo Dual Energy Viewer from Siemens Healthcare
  410. Corrective Action of Diagnostica Stago for reagents
  411. Urgent Field Safety Notice for FLEXI-SEAL Fecal Management System Kit by ConvaTec Limited…
  412. Urgent field safety notice for HIPP (F) / Hang & Go, RanD S.r.l.
  413. Urgent Field Safety Notice for cobas 8000 by Hitachi High-Technologies Corporation
  414. Urgent Field Safety Notice for SOMATOM GO.UP and SOMATOM go.Now by Siemens Healthcare GmbH…
  415. Information about incorrect display of Pulsed Wave Doppler velosity values on reloaded…
  416. Safety Notice for Posey Connecting Straps/Belts/Locking Cuffs, Posey
  417. Recall of Bicontact S Plasmapore 12/14 size 17 mm, Aesculap
  418. Safety Notice for syngo.plaza, Siemens Healthcare
  419. Corrective action for the Digital Radiography X-Ray System DX-D 100 Type 5410 or DX-D 100…
  420. Urgent Field Safety Notice for Algovita Spinal Cord Stimulation System / Clinician…
  421. Recall for ADVIA Chemistry Gentamicin_2 (GENT_2) and Valproic Acid_2 (VPA_2) Reagent…
  422. Refitting of hospital beds for children model Comforta, Joh. Stiegelmeyer
  423. Corrective action for the RayStation 4.7, RaySearch Laboratories AB
  424. Expanded Recall for Biosense Webster's 6' Interface Cable
  425. Corrective action concerning the Instructions for Use for S.I.M.E.O.N. products…
  426. Information about the cardiovascular X-ray Systems Allura Xper FD10/10 and Allura Xper…
  427. Customer advisory notification for PQ-series Scanners, Philips
  428. Corrective action for the Intuitive Surgical Large Clip Applier for use with the da Vinci®…
  429. VIDAS Anti-HBs Total II
  430. Universal Plus Laparoscopic Electrodes
  431. Jarvik 2000 Ventricular Assist System components
  432. Recall of customer specific OP sets, Paul Hartmann AG
  433. Safety Notice for Compax 40E X-ray systems, GE Healthcare
  434. Recall of QUATTROcare spray cans from KaVo Dental
  435. Corrective action for the CARESCAPE Monitor B650, GE Healthcare
  436. Recall of TraXis Fixed Trial Rod and Rasp instruments from Abbott Spine
  437. Safety Notice for Natus neoBLUE mini, Natus Medical
  438. Safety Corrective Action for ReNew Long Fenestrated Grasper, Microline Surgical Inc.
  439. Recall for CircuCool™ Fluid Circulation Pump, Boston Scientific
  440. Corrective action for Central Monitors model CNS-6201, NIHON KOHDEN Corporation
  441. Corrective action for VP 2000 Processor, 100V, 117V and 230V, Abbott
  442. Urgent Field Safety Notice for aixstent Duodenum TTS by bess pro gmbh
  443. Recall of all Power Medical Interventions, Inc. Products, Covidien
  444. Urgent Field Safety Notice for Podolog Stella 2 und 3 by Hellmut Ruck GmbH
  445. Recall of the superDimension Bronchus System and the superDimension Bronchus disposable…
  446. Information for Sub-Acute Care Ventilator Carina, Dräger
  447. Recall for MiniMed Paradigm Veo insulin pump, Medtronic
  448. Lot Recall for Feeding Tube with Luer Lock, Convatec
  449. TomoTherapy has issued a Field Safety Notice about a possible error in the irradiation by…
  450. Recall for surgical handpieces PowerPro®, PowerProMax™ and Mpower™, ConMed Linvatec
  451. Urgent Field Safety Notice for SeQuent Please OTW by B. Braun Melsungen AG
  452. Field Safety Notice of application syngo Workflow MLR from Siemens Healthcare
  453. Lot Recall for Uromed Silicone-Balloon-Catheter „soft“ and Uromed Cystobag-urinary drain…
  454. Urgent Field Safety Notice for Dimension TNI, DimnesioV DIGXN, E2, FERR, PRL, TSH by…
  455. Urgent Field Safety Notice for Flex Arm by Oberdorf Synthes Produktions GmbH
  456. Advisory notice regarding the expiration date for IVUS motor sterile plastic cover from…
  457. Lot Recall for the Ascendra2™ Transapical Delivery System, Edwards Lifesciences LLC
  458. Recall of the CAST 2000 Elisa (lot number 4421.1) from Bühlmann
  459. Field Safety Notice for Basin Liners, Microtek Medical (Medline)
  460. Advisory Notice for the Guidant Acrobat Vacuum Stabilizer Systems from Guidant
  461. Urgent Field Safety Notice for ARCHITECT SHBG Reagent Kit by Abbott GmbH & Co. KG
  462. Extended Recall for Ureofix catheter kits, B. Braun
  463. Urgent Field Safety Notice for 2-MET Urine ELISA Fast Track by LDN Labordiagnostika Nord…
  464. Recall for prefilled blocking syringes, Coloplast
  465. Recall for Ureofix catheter kits, B. Braun
  466. Batch recall of D-Dimer Rapid Test D-DIMK20, Diagnostik Nord GmbH
  467. Urgent Field Safety Notice for MassTox® Antimycotic Drugs/EXTENDED Cali/Con by…
  468. Recall of the Rotating Hemostatic Valves from Abbott
  469. Recall/Corrective Action for CK reagent, lot 1120909, ERBA diagnostics Mannheim GmbH
  470. Corrective action for the RECLAIM® Taper Sleeve Protector Instrument, DePuy Orthopaedics…
  471. Information for BuckyDiagnost and DigitalDiagnost systems with NICOL V3 Collimator…
  472. Safety Notice for Oxylog 3000, Dräger
  473. Safety Notice for AXIOM Iconos R200, Siemens
  474. Urgent Safety Notice for the NANOS Femoral neck prosthesis, OHST Medical Technology
  475. Corrective action for the Ingenia, Intera, Achieva and Achieva MR systems on R5.1.1 and…
  476. Urgent Field Safety Notice for BORA, DRAGON, MIRAGE, SPECTRA BLITZ, STREAM by Invacare…
  477. Recall for Universal Cables, ConMed Linvatec
  478. Lot recall of Damon 3MX Bicuspid Brackets, ORMCO
  479. Important Safety Notice for Dräger monitor holders with AC2000, Dräger Medical GmbH
  480. Urgent Field Safety Notice for 1) DynaMesh PR2 soft 2B / 2) DynaMesh PR4 soft 2 by FEG…
  481. Update for cobas b 221 system, Roche Diagnostics GmbH
  482. Recall for the BD Preset 3ml. Arterial Gas Syringe, Becton, Dickinson and Company
  483. Safety Notice for the Philips Allura Xper systems and Allura CV20, Philips
  484. Safety Notice for the product Duocage, SBM SAS
  485. Corrective action for Telemetry Systems, NIHON KOHDEN Corporation
  486. Safety Notice concerning a corrective action of the Corpuls3 defibrillator, GS…
  487. Sulfasalazine/Sulfapyridine-Drug Interference, Roche Diagnostics
  488. Urgent Safety Notice for the Fabius MRI anaesthesia systems, Dräger Medical GmbH
  489. Urgent field safety notice for Synchron systems Cholesterol / Creatinine / HDL Cholesterol…
  490. Safety Notice for MAMMOMAT Inspiration Biopsy Unit, Siemens
  491. Recall for ONLINE TDM Gentamicin Assay, Roche
  492. Urgent field safety notice for Digitoxin OSR6403, Beckman Coulter Inc.
  493. Corrective Action for VITROS 5.1 FS System Software-Version 2.6.1 and below, VITROS 4600…
  494. Corrective action for the Dimension Vista® 500 Intelligent Lab System or Dimension Vista®…
  495. Urgent Field Safety Notice for Access BR Monitor by Beckman Coulter, Inc.
  496. Information concerning the HL 30 pumps from Maquet
  497. Recall for Neuron 070 Delivery Catheter, Penumbra Inc.

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