RecallReported September 23, 2026
Class II recall by F & A Foundation
Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x…
FDA's enforcement report of September 23, 2026 lists a Class II recall by F & A Foundation of Tulsa, OK. Product: Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907; 11mm x 10mm/152-31110; 15mm x 12mm/152-31512; 18mm x…. Status: Ongoing.
On the record
- Recalling firm
- F & A Foundation
- Location
- Tulsa, OK
- Classification
- Class II
- Status
- Ongoing
- Recall number
- Z-3211-2026
- Product type
- Devices
- Recall initiated
- 2026-07-15
- Reported by FDA
- 2026-09-23
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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