Class IIOngoingZ-1492-2026
Vascutek, Ltd. recalls Gelsoft Plus
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.…
Vascutek, Ltd.Mar 11, 2026
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–2 of 2 recalls
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.…
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising;…