FDA Medical Devices
U.S. Food and Drug Administration — Medical device recalls
26,000 recalls · Page 55 of 520
Moderate Oct 2, 2024
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of t…
Philips North America Llc
Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal…
Boston Scientific Corporation
Moderate Oct 2, 2024
Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structu…
Philips North America Llc
Moderate Oct 2, 2024
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal …
Boston Scientific Corporation
Moderate Oct 2, 2024
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
American Contract Systems, Inc.
Moderate Oct 2, 2024
BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD P…
Becton Dickinson & Co.
Moderate Oct 2, 2024
ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.0, 2.5 Diagnostic Ultrasound …
Siemens Medical Solutions USA, Inc.
Moderate Oct 2, 2024
AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining…
Boston Scientific Corporation
Moderate Oct 2, 2024
WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal…
Boston Scientific Corporation
Moderate Oct 2, 2024
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
GE Healthcare
Moderate Oct 2, 2024
Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123
Karl Storz Endoscopy
Moderate Oct 2, 2024
Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123
Karl Storz Endoscopy
Critical Oct 2, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Datascope Corp.
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.
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.
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
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
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.
Moderate Oct 2, 2024
Paracentesis Thoracente, SLPT76H; Medical convenience kit
American Contract Systems, Inc.
Critical Oct 2, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Datascope Corp.
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.)
Moderate Oct 2, 2024
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GV…
Microcare Medical
Moderate Oct 2, 2024
Cath Lab Pack, CECL02P; Medical convenience kit
American Contract Systems, Inc.
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.
Low Oct 2, 2024
eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
T.G. Eakin Limited
Moderate Oct 2, 2024
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
CooperSurgical, Inc.
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
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
Moderate Oct 2, 2024
prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5
Centinel Spine, Inc.
Moderate Oct 2, 2024
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
Siemens Medical Solutions USA, Inc.
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
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
Moderate Oct 2, 2024
Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Karl Storz Endoscopy
Moderate Oct 2, 2024
Endovascular AAA Pack, ESED52B; Medical convenience kit
American Contract Systems, Inc.
Moderate Oct 2, 2024
Shoulder, SESH18I; Medical convenience kit
American Contract Systems, Inc.
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
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.
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
Moderate Oct 2, 2024
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Dr Franz Koehler Chemie Gmbh
Critical Oct 2, 2024
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
Smiths Medical ASD Inc.
Moderate Oct 2, 2024
Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123
Karl Storz Endoscopy
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
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
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
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
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
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
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
Moderate Oct 2, 2024
Cysto, FTCY03L; Medical convenience kit
American Contract Systems, Inc.
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.