Reported Sep 23, 2026 · Ongoing · Updated Sep 29, 2026

Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x…

F & A Foundation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: F & A Foundation · 6303 E 102nd St · Tulsa, OK · 74137-7041

Lot codes and dates: REF/UDI-DI/Lot/Expiration
152-30907/00854325007011/24-0627/10/27/2029
152-31110/00854325007028/24-0628/10/21/2029
152-31512/00854325007042/24-0629/10/22/2029
152-31818/00854325007073/24-0630/10/23/2029
152-32020/00854325007189/24-0631/10/28/2029
152-40907/00854325007010/24-0633/10/16/2029
152-41110/00854325007127/24-0634/10/20/2029
152-41512/00854325007141/24-0635/10/20/2029
152-41818/00854325007172/24-0636/10/16/2029
152-42020/00854325007189/24-0637/10/16/2029
Amount recalled: 600

Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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