Vascutek, Ltd.
Complete recall history across all FDA and CPSC categories — 6 total recalls
Vascutek, Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (6)
FDA medical device enforcement actions by Vascutek, Ltd.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 18, 2025 | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE... | Gelatin sealed woven polyester prostheses devices, designed for vascular repa... | Class II |
| Jul 8, 2021 | The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular... | The devices contained the IFU for distribution to ROW (rest of world) consign... | Class II |
| Jul 8, 2021 | The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-... | The devices contained the IFU for distribution to ROW (rest of world) consign... | Class II |
| May 15, 2015 | Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is an... | Product was labeled as a 30cm graft, when in fact the graft in the box was a ... | Class II |
| May 15, 2015 | Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an... | Product was labeled as a 30cm graft, when in fact the graft in the box was a ... | Class II |
| Jul 15, 2014 | Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO c... | The cautery that is provided with the Gelweave graft in the box has a shorter... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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