The Recall Desk

Manufacturer

Vascutek, Ltd.

6 recalls in our database name Vascutek, Ltd. as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2026-03-11

Of the 6 recalls from Vascutek, Ltd. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • ModerateFDA (Devices)·Z-1492-2026·2026-03-11

    Vascular grafts recalled after expiry dates were calculated from packaging

    Vascutek is recalling Gelsoft Plus and Gelweave vascular prostheses because they were labeled with an additional month of shelf life, expiry having been calculated from packaging rather than gel impregnation.

    Product
    Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2021·2021-10-06

    Vascutek Vascular Grafts Recalled for Incorrect Instructions for Use

    Vascutek is recalling vascular grafts distributed to Puerto Rico and Guam that contained wrong Instructions for Use prepared for international rather than U.S. consignees. Improper instructions pose a risk of incorrect device use.

    Product
    The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Valsalva vascular grafts: (1) Vascutek Terumo Gelsoft Gelatin Impregnated Knitted Vascular Prosthe
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2543-2021·2021-10-06

    Carotid and Gelsoft vascular patches recalled for incorrect instructions

    Vascutek vascular patches were distributed with rest-of-world instructions instead of U.S. instructions. The 159 units distributed to Puerto Rico and Guam have incorrect Instructions for Use for U.S. use.

    Product
    The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1912-2015·2015-07-08

    Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling

    Vascutek, Ltd. is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.

    Product
    Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1913-2015·2015-07-08

    Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling

    Vascutek is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.

    Product
    Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2266-2014·2014-08-27

    Vascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling

    Vascutek is recalling Gelweave Vascular Prostheses because the included cautery has a shorter shelf life than the graft, creating a labeling discrepancy.

    Product
    Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
    Category
    Medical Device
    Distribution
    Distributed nationwide