October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended fo
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended fo
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intende
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System I
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inte
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inte
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intend
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intend
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
Boston Scientific Corporation recalls WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Inten
Hazard: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
October 2, 2024Medical DevicesFDA
TMJ Solutions Inc recalls Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Mod
Hazard: Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
October 2, 2024Medical DevicesFDA
T.G. Eakin Limited recalls eakin Cohesive seal, small, Model Number 839002, ostomy barrier seal
Hazard: On lot of cartons of Eakin Cohesive small seals, Model Number 839002 may contain blistered seals labelled as 839005.
October 2, 2024Medical DevicesFDA
Fisher & Paykel Healthcare, Ltd. recalls PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provi
Hazard: Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Inguinal Hernia Graft C-IHM-10X15 - To reinforce soft tissues in the inguinal floor to repair inguinal hernias
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fis
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fis
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fis
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi
Hazard: Products expire prior to the expiration date printed on the product labeling
October 2, 2024Medical DevicesFDA
Cook Biotech, Inc. recalls Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fi
Hazard: Products expire prior to the expiration date printed on the product labeling