Surgical Staple Reinforcement Devices Recalled for Incorrect Expiration Dating
W.L. Gore & Associates recalled 51 units of GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement due to incorrect expiration date labeling. The devices were labeled with a four-year and ten-day expiration date instead of the validated two-year shelf life.
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: This FDA Class II recall involves mislabeling of the device expiration date, creating a risk-of-harm situation where devices could be used beyond their validated two-year shelf life. No injuries or adverse events have been reported.
Plain-English summary
W.L. Gore & Associates is recalling 51 units of GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers (catalog number 1BSGC25, lot number 26590654). The recalled devices were labeled with an expiration date of four years and ten days rather than the validated shelf life of two years.
These devices were distributed nationwide to healthcare facilities in California, Georgia, Illinois, North Carolina, Ohio, Oklahoma, and Washington. The incorrect labeling creates a risk that devices could be used beyond their validated stability period.
Healthcare providers who have received these devices should verify possession of lot number 26590654 and take appropriate steps to prevent use of the affected devices. No injuries or adverse events have been reported in connection with this recall.
The recalled product
- Product
- GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
- Manufacturer
- W.L. Gore & Associates, Inc.
- Category
- Medical Device — Surgical
- Affected units
- 51
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 (3)
- Catalog Number: 1BSGC25
- UDI-DI: 00733132600755
- Lot number: 26590654
Distribution
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