Septal Occluder Devices Recalled for Incorrect Expiration Date Label
W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Expiration date mislabeling on an FDA Class II medical device creates potential risk of use beyond actual product expiration, though no injuries or illnesses have been reported.
Plain-English summary
W L Gore & Associates, Inc. is recalling 222 units of the GORE Cardioform Septal Occluder (Catalogue Number GSXE0030B, UDI: 00733132620128) due to labeling error. The affected devices are labeled with a 3-year expiration date instead of the correct 2-year expiration period.
The recalled devices were distributed throughout the United States and to multiple countries including Australia, Austria, Canada, Switzerland, Germany, Denmark, Spain, France, United Kingdom, Greece, Ireland, Italy, Mexico, Netherlands, Norway, Portugal, Saudi Arabia, and Sweden. Affected units can be identified by serial numbers 22689696 through 23569078.
Incorrect expiration date labeling poses a risk of device use beyond the actual expiration date. Healthcare providers should immediately stop using affected devices and contact W L Gore & Associates for replacement or additional information.
The recalled product
- Product
- REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Septal Occluder
- Hazard
- Affected units
- 222
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 (1)
- serial numbers 22689696 through 23569078
Distribution
Part of a larger recall action
This product is one of 9 recalled by W L Gore & Associates, Inc. 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 9 products in this recall →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
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 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
- HighGORE CARDIOFORM Septal Occluder Recalled for Incomplete Quality Documentation
FDA (Devices) · 2023-02-08
- HighSurgical Staple Reinforcement Devices Recalled for Incorrect Expiration Dating
FDA (Devices) · 2024-08-14
- HighStryker Recalls Mislabeled Intracardiac Ultrasound Catheters Due to Expiration Date Error
FDA (Devices) · 2021-02-03
- ModerateGore Tips Set Device Recall: Incorrect Expiration Date Labeling
FDA (Devices) · 2023-08-09
- HighGORE CARDIOFORM ASD Occluder Cardiovascular Implants Recalled for Manufacturing Test Failure
FDA (Devices) · 2022-11-02
- HighGore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide
FDA (Devices) · 2021-09-01