Vascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling
Vascutek is recalling Gelweave Vascular Prostheses because the included cautery has a shorter shelf life than the graft, creating a labeling discrepancy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class II recall involving a labeling discrepancy regarding shelf life. It fits the 'Moderate' criterion for minor labeling errors or voluntary precautionary recalls, as no injuries or illnesses are reported.
Plain-English summary
Vascutek, Ltd. is recalling Gelweave (TM) Vascular Prostheses. The recall involves 63,162 units distributed nationwide, including in Alabama, Arkansas, Arizona, California, Colorado, Connecticut, the District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.
The reason for the recall is a labeling discrepancy regarding shelf life. The cautery provided with the Gelweave graft in the box has a shorter shelf life indicated on its label (4 years) compared to the shelf life of the graft itself (5 years). This mismatch may lead to confusion regarding the expiration of the components.
Healthcare providers and facilities should stop using the affected products and contact Vascutek, Ltd. for instructions on return or replacement. The affected products are identified by specific catalog codes listed in the recall notice, including codes such as 731030, 731032, and 731034.
The recalled product
- Product
- Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
- Manufacturer
- Vascutek, Ltd.
- Hazard
- Affected units
- 63,162
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)
- 731030
- 731032
- 731034
- 731036
- 731038
- 731206
- 731218
- 731220
- 731222
- 731224
- 731226
- 731228
- 731407
- 731506
- 731507
- 731508
- 731509
- 731510
- 731512
- 731514
Distribution
Related recalls
Same manufacturer · Vascutek, Ltd.
See all →- ModerateVascular grafts recalled after expiry dates were calculated from packaging
FDA (Devices) · 2026-03-11
- HighVascutek Vascular Grafts Recalled for Incorrect Instructions for Use
FDA (Devices) · 2021-10-06
- HighCarotid and Gelsoft vascular patches recalled for incorrect instructions
FDA (Devices) · 2021-10-06
- ModerateVascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling
FDA (Devices) · 2015-07-08
- ModerateVascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling
FDA (Devices) · 2015-07-08
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
Similar recalls
- ModerateTerumo Recalls Mislabelled Vascutek Gelsoft Vascular Grafts
FDA (Devices) · 2013-11-27
- ModerateVascular grafts recalled after expiry dates were calculated from packaging
FDA (Devices) · 2026-03-11
- ModerateVascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling
FDA (Devices) · 2015-07-08
- HighVascutek Vascular Grafts Recalled for Incorrect Instructions for Use
FDA (Devices) · 2021-10-06
- ModerateAssuramed Recalls ProTime Microcoagulation System Cuvettes Due to Storage Issues
FDA (Devices) · 2013-09-25
- HighThoracic Stent-Graft System Recalled Due to Dimensional Defect
FDA (Devices) · 2023-01-25