VASCUTEK LTD. FDA Inspection Record
VASCUTEK LTD. is an FDA-registered facility (FEI 3002808437) located in Inchinnan Renfrewshire, GB. RegDataLab tracks 2 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Nov 17, 2022: Voluntary Action Indicated (VAI)
- Inspections on record
- 2 (1 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 4, latest Dec 18, 2025
- Import refusals
- 6
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Nov 17, 2022 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 23, 2012 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Dec 18, 2025 | Class II | Z-1492-2026 | Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE… Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf… |
| Jul 8, 2021 | Class II | Z-2542-2021 | The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem… and 1 more product The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees. |
| May 15, 2015 | Class II | Z-1912-2015 | Gelseal Straight Diameter 8mm Length 15cm.
Vascular graft prosthesis is an implanted… and 1 more product Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft. |
| Jul 15, 2014 | Class II | Z-2266-2014 | Gelweave (TM) Vascular Prostheses
Manufactured by - VASCUTEK Ltd
a TERUMO company The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4… |
FDA record score
9 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
5 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-1492-2026, this FEI as the recalling firm | Dec 18, 2025 | 4 x 1 | 4 |
| Inspection classified VAI | Nov 17, 2022 | 6 x 0.6 | 3.6 |
| Class II recall Z-2542-2021, this FEI as the recalling firm | Jul 8, 2021 | 4 x 0.25 | 1 |
| Class II recall Z-1912-2015, this FEI as the recalling firm | May 15, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-2266-2014, this FEI as the recalling firm | Jul 15, 2014 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Vascutek, Ltd.
- Location
- Inchinnan Renfrewshire (GB)
- Source
- device