BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH… — Class II medical device recall Z-0153-2026
Ongoing recall by BioPro, Inc., reported 2025-10-22, distributed in MI, TX. Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of
| Recall number | Z-0153-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioPro, Inc., Port Huron, MI, United States |
| Recall initiated | 2025-09-09 |
| Classified | 2025-10-14 |
| Reported by FDA | 2025-10-22 |
| Distributed | MI, TX |
| Quantity | 147 total |
| Reason classes | sterility |
Product
BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
Reason for recall
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
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-0153-2026. 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.