Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 57 of 548
FDA Devices Moderate Oct 2, 2024
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
GE Healthcare
FDA Devices Moderate Oct 2, 2024
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Karl Storz Endoscopy
FDA Devices Moderate Oct 2, 2024
Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
Karl Storz Endoscopy
FDA Devices Critical Oct 2, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Datascope Corp.
FDA Devices Moderate Oct 2, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN):…
Cook Biotech, Inc.
FDA Devices Moderate Oct 2, 2024
ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, wi…
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal lumi…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esop…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GP…
Cook Biotech, Inc.
FDA Devices Moderate Oct 2, 2024
Paracentesis Thoracente, SLPT76H; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Critical Oct 2, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Datascope Corp.
FDA Devices Moderate Oct 2, 2024
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Waldemar Link GmbH & Co. KG (Corp. Hq.)
FDA Devices Moderate Oct 2, 2024
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GV…
Microcare Medical
FDA Devices Moderate Oct 2, 2024
Cath Lab Pack, CECL02P; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humid…
Fisher & Paykel Healthcare, Ltd.
FDA Devices Low Oct 2, 2024
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
T.G. Eakin Limited
FDA Devices Moderate Oct 2, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
CooperSurgical, Inc.
FDA Devices Moderate Oct 2, 2024
WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esoph…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophage…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Centinel Spine, Inc.
FDA Devices Moderate Oct 2, 2024
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Siemens Medical Solutions USA, Inc.
FDA Devices Moderate Oct 2, 2024
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the in…
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Karl Storz Endoscopy
FDA Devices Moderate Oct 2, 2024
Endovascular AAA Pack, ESED52B; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
Shoulder, SESH18I; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of …
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN):…
Cook Biotech, Inc.
FDA Devices Moderate Oct 2, 2024
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal …
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Dr Franz Koehler Chemie Gmbh
FDA Devices Critical Oct 2, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Smiths Medical ASD Inc.
FDA Devices Moderate Oct 2, 2024
Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Karl Storz Endoscopy
FDA Devices Moderate Oct 2, 2024
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure o…
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skelet…
Stryker Spine
FDA Devices Moderate Oct 2, 2024
AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaini…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF,…
TMJ Solutions Inc
FDA Devices Moderate Oct 2, 2024
Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the h…
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal…
Philips North America Llc
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophagea…
Boston Scientific Corporation
FDA Devices Moderate Oct 2, 2024
Cysto, FTCY03L; Medical convenience kit
American Contract Systems, Inc.
FDA Devices Moderate Oct 2, 2024
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN)…
Cook Biotech, Inc.
FDA Devices Moderate Oct 2, 2024
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Karl Storz Endoscopy
FDA Devices Moderate Oct 2, 2024
Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN)…
Cook Biotech, Inc.
FDA Devices Moderate Oct 2, 2024
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray dete…
FUJIFILM Healthcare Americas Corporation
FDA Devices Moderate Oct 2, 2024
Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): …
Cook Biotech, Inc.
FDA Devices Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsi…
Boston Scientific Corporation
FDA Devices Moderate Sep 25, 2024
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
Boston Scientific Corporation
FDA Devices Moderate Sep 25, 2024
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
CareFusion 303, Inc.
FDA Devices Critical Sep 25, 2024
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
Baxter Healthcare Corporation
FDA Devices Moderate Sep 25, 2024
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Num…
B Braun Medical Inc