Vascutek recalls

Vascutek has 6 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 11 Mar 2026. 1 is still ongoing. 1 was reported in the last 12 months.

Total recalls6since 2014

Last 12 months1reported

Class I00% of total

Ongoing1latest 11 Mar 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 1 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why vascutek is recalled

Product types

Heart & Vascular Devices583%
Other Medical Devices117%

By year

2026117%
2021233%
2015233%
2014117%

Ongoing vascutek recalls

1 active

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Device	CLASS II	Gelsoft Plus recalled by Vascutek	Vascutek	Labeling Errors	Nationwide

All vascutek recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026Device	CLASS II	Gelsoft Plus recalled by Vascutek	Vascutek	Labeling Errors	Nationwide
6 Oct 2021Device	CLASS II	The Instructions for Use (IFU) for: Carotid Patch recalled by Vascutek	Vascutek	Other	PR
6 Oct 2021Device	CLASS II	The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate recalled	Vascutek	Sterility	PR
8 Jul 2015Device	CLASS II	Gelseal Straight Diameter Length Vascular graft prosthesis recalled	Vascutek	Packaging Defects	MI
8 Jul 2015Device	CLASS II	Gelseal Straight Diameter Length Vascular graft prosthesis recalled	Vascutek	Packaging Defects	MI
27 Aug 2014Device	CLASS II	Gelweave (TM) Vascular Prostheses recalled by Vascutek	Vascutek	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.