W.L. Gore & Associates, Inc. is recalling 51 units of the GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (25mm) because the products were labeled with an incorrect expiration date. The devices were marked as being safe to use for four years and ten days, when they have actually only been validated for a two-year shelf life. These medical devices are used to reinforce staple lines during surgical procedures, and using an expired device could mean the bioabsorbable material does not perform as intended. These units were distributed to facilities in California, Georgia, Illinois, North Carolina, Ohio, Oklahoma, and Washington.
The device may have degraded beyond its validated safety period, potentially leading to a loss of material integrity or performance during surgical staple line reinforcement.
Contact manufacturer for instructions
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.