CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report

Gore Seamguard Bioabsorbable Staple Line Reinforcement recalled

W.L. Gore & Associates is recalling Gore Seamguard Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, distributed nationwide in the US. The recall was initiated on 3 Jul 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;

Quantity recalled51 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2513-2024
FDA event ID: 94976
Recalling firm: W.L. Gore & Associates, Elkton, MD
Classification: Class II
Status: Ongoing
Recall initiated: 3 Jul 2024
FDA classified: 6 Aug 2024
Reported: 14 Aug 2024
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

3 Jul 2024	Recall initiated by company
6 Aug 2024	Classified by FDA	+34 days
14 Aug 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Devices were labeled with an expiration date of four years and ten days rather than the validated two years.

Product as listed by the FDA

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;

Where it was distributed

US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.

Nationwide California Georgia Illinois North Carolina Ohio Oklahoma Washington

Questions about this recall

Why was it recalled?

Devices were labeled with an expiration date of four years and ten days rather than the validated two years.

Which lots are affected?

Catalog Number: 1BSGC25; UDI-DI: 00733132600755; Lot number: 26590654;

Where was it sold?

US Nationwide distribution in the states of CA, GA, IL, NC, OH, OK, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from W.L. Gore & Associates

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