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 13–15 of 15 recalls
Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.…
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older.…
The console label for affected devices is missing the "DANGER" symbol.