Vascutek Gelseal Vascular Grafts Recalled for Incorrect Length Labeling
Vascutek, Ltd. is recalling 12 Gelseal vascular grafts labeled as 30cm but actually 15cm. The devices were distributed in Michigan and four other countries.
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: The recall is classified as FDA Class II and involves a minor labeling error regarding product dimensions, with no reported injuries or illnesses in the source text.
Plain-English summary
Vascutek, Ltd. is recalling 12 units of Gelseal Straight Diameter 8mm Length 15cm vascular graft prostheses. The recall is due to a labeling error where the product was labeled as a 30cm graft, but the graft inside the box was actually a 15cm graft.
The affected devices are identified by Product Code 431508, Batch 301509/01, and Serial Numbers 0001515180 through 0001515191. These devices were distributed in the state of Michigan (USA), and the countries of the United Kingdom, Australia, Poland, and Germany.
Vascular graft prostheses are implanted devices intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. The source text does not specify instructions for consumers or healthcare providers regarding the handling of these specific units.
The recalled product
- Product
- Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access.
- Manufacturer
- Vascutek, Ltd.
- Category
- Medical Device — Vascular Graft
- Hazard
- Affected units
- 12
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 (14)
- Product Code 431508
- Batch 301509/01
- Serial Numbers 0001515180
- 0001515181
- 0001515182
- 0001515183
- 0001515184
- 0001515185
- 0001515186
- 0001515187
- 0001515188
- 0001515189
- 0001515190
- 0001515191
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Vascutek, Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →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 Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling
FDA (Devices) · 2014-08-27
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
- HighVascular Graft Mislabeled; Packaging Labels Do Not Match Product Specifications
FDA (Devices) · 2022-03-16
- HighGore Propaten Vascular Graft Pediatric Shunt Dimension Labeling Error Recall
FDA (Devices) · 2021-08-25
- HighGore Propaten Vascular Graft Pediatric Shunt Diameter Labeling Error
FDA (Devices) · 2021-08-25
- ModerateVascutek Recalls Gelweave Vascular Prostheses Due to Cautery Shelf Life Labeling
FDA (Devices) · 2014-08-27
- HighVascutek Vascular Grafts Recalled for Incorrect Instructions for Use
FDA (Devices) · 2021-10-06