Vascutek, Ltd. FDA Recalls

3 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 6Class IIDec 18, 2025Gelatin sealed woven polyester prostheses devices, designed	Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with	Class IIDevices	Dec 18, 2025
The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave StraiClass IIJul 8, 2021The devices contained the IFU for distribution to ROW (rest	The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.	Class IIDevices	Jul 8, 2021
The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid PatClass IIJul 8, 2021The devices contained the IFU for distribution to ROW (rest	The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.	Class IIDevices	Jul 8, 2021