Recall Atlas

Vascutek recalls

2 official recalls and safety alerts involving Vascutek since 2021-10, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Vascutek or the relevant agency.

  1. 2026-03-11
  2. US
    Drugs & medicalClass II

    Vascutek, Ltd. recalls Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE,…

    Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation (date of…

    FDA · DeviceVascutek, Ltd.US Nationwide distribution including in the states of FL, PA, TX, NC, NY, CA,…Official notice →
  3. 2021-10-06
  4. US
    Drugs & medicalClass II

    Vascutek, Ltd. recalls The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave…

    The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

    FDA · DeviceVascutek, Ltd.Distribution was made to PR and Guam.Official notice →