Vascutek, Ltd. recalls
Every recall we track for Vascutek, Ltd. — 3 in all, from 2021–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
3 recalls since 2017.
All FDA recall records for Vascutek, Ltd. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 2 | 0 | 2 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Vascutek, Ltd. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Vascutek, Ltd. recalls
2 shown- Lower riskMedical device
Vascutek, Ltd. recalls Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE,
Vascutek recalls Gelsoft Plus and Gelweave vascular repair devices that were incorrectly labeled with an additional month of shelf life. The device expiry should have been calculated from gel impregnation (date of manufacture) but was incorrectly calculated from device packaging.
VascutekDec 18, 2025 - Lower riskMedical device
Vascutek, Ltd. recalls The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave
Vascutek recalls certain Gelsoft vascular grafts due to incorrect Instructions for Use distribution to international consignees instead of U.S. consignees. No action required for users.
VascutekJul 8, 2021
Vascutek, Ltd. recall questions
How many recalls has Vascutek, Ltd. had?
3 recalls from Vascutek, Ltd. are on record with U.S. safety agencies, from 2021–2025.
What is the most recent Vascutek, Ltd. recall?
Vascutek, Ltd. recalls Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE,, dated Dec 18, 2025. Every Vascutek, Ltd. recall is listed on this page, newest first.
What should I do if I have a recalled Vascutek, Ltd. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Vascutek, Ltd. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.