Vascular grafts recalled after expiry dates were calculated from packaging
Vascutek is recalling Gelsoft Plus and Gelweave vascular prostheses because they were labeled with an additional month of shelf life, expiry having been calculated from packaging rather than gel impregnation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers minor labelling errors: the fault is a shelf life calculated from the wrong starting point, and the source describes no defect in the prostheses themselves.
Plain-English summary
Vascutek, Ltd. is recalling Gelsoft Plus and Gelweave gelatin sealed woven polyester prostheses, designed for vascular repair, across a large range of REF numbers. About 37,430 units were distributed nationwide across the United States. The FDA has classified this recall as Class II.
The devices were incorrectly labelled with an additional month of shelf life. Device expiry should have been calculated from gel impregnation, the date of manufacture, but it was incorrectly calculated from device packaging. The source record does not describe a defect in the prostheses themselves.
All Gelsoft Plus devices with an item number ending 'E-B' are affected, each with its own REF, item number and UDI-DI listed in the FDA enforcement record.
Facilities can identify affected devices by the REF and item numbers above, and may contact Vascutek, Ltd. for further information.
The recalled product
- Product
- Gelsoft Plus, REF: 635024PE, 631514PE, 631222PE, 633008PE, 633010PE, 633007PE, 636010PE, 632522PE, 633012PE, 635018PE, 631516PE, 636016PE, 631220PE, 631608PE, 631206PE, 631407P50E, 631508PE, 636008PE, 636006PE, 632518PE, 634008PE, 634006PE, 631218PE, 632211PE, 634007PE, 633006PE,
- Manufacturer
- Vascutek, Ltd.
- Category
- Medical Device — Vascular graft
- Hazard
- labelling-error
- expiry-dating
- shelf-life
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- All Gelsoft Plus devices (any item number ending 'E-B' e.g. 631206PE-B)
- REF
- Item Number
- UDI-DI(GTIN): 635024PE
- 635024PE-B
- 5037881166636
- 631514PE
- 631514PE-B
- 5037881166858
- 631222PE
- 631222PE-B
- 5037881166896
- 633008PE
- 633008PE-B
- 5037881166698
- 633010PE
- 633010PE-B
- 5037881166711
- 633007PE
- 633007PE-B
Distribution
Distributed nationwide across the United States.
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