Frontier Devices — Class II medical device recall Z-2580-2025
Ongoing recall by Folsom Metal Products, Inc., reported 2025-09-24, distributed nationwide. Labeling includes shelf life that has not been validated.
| Recall number | Z-2580-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Folsom Metal Products, Inc., Pelham, AL, United States |
| Recall initiated | 2025-08-21 |
| Classified | 2025-09-17 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00850014548032 |
| Model numbers | 301.914S2 |
Product
Frontier Devices, REF: 301.914S2, 14 mm Distraction Pin, 10 double packs , Rx Only, Sterile
Reason for recall
Labeling includes shelf life that has not been validated.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2580-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.