W L Gore Recalls 15 Thoracic Stent Grafts Due to Labeling Error
W L Gore & Associates is recalling 15 Conformable Thoracic Stent Grafts distributed in Japan because incorrect labels were placed on the primary and secondary packaging.
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, but the source text explicitly states the issue is an incorrect label on packaging and does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
W L Gore & Associates, Inc. is recalling 15 units of the Conformable Thoracic Stent Graft. This medical device is intended for the endovascular repair of lesions of the descending thoracic aorta. The recall is limited to units distributed internationally to the country of Japan.
The recall was initiated because incorrect labels were placed on both the primary and secondary packages of the affected devices. The specific part number for the recalled devices is TGM343420J. The affected serial numbers range from 21225065 to 21225084.
Healthcare providers and patients who have received these specific devices should contact W L Gore & Associates, Inc. for further instructions. The source text does not report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Vascular Stent
- Hazard
- Affected units
- 15
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · W L Gore & Associates, Inc.
See all →- ModerateGORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2026-08-19
- ModerateGORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2026-08-19
- SevereGORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall
FDA (Devices) · 2026-07-08
- HighVascular grafts recalled after delamination reports prompt instructions for use update
FDA (Devices) · 2025-10-08
- HighW L Gore Recalls Heparin Viabahn VBX Endoprosthesis Due to Packaging Defects
FDA (Devices) · 2024-09-11
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
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- SevereGORE TAG CONFORMABLE Thoracic Stent Graft Recall for Deployment Issue
FDA (Devices) · 2020-11-04
- HighGORE TAG Stent Graft Recalled Due to Delivery Catheter Removal Issue
FDA (Devices) · 2020-11-04
- 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
- HighGORE TAG Thoracic Endoprosthesis Recalled for Incomplete Deployment Risk
FDA (Devices) · 2017-11-01
- HighRELAY PRO Thoracic Stent-Graft System recalled for incorrect size
FDA (Devices) · 2024-04-03