# FDA recall Z-0148-2026

> **BioPro, Inc.** · Class II · device recall initiated 2025-09-09.

## Product

BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads    Part ID/Description:  18593	HEAD FEMORAL 22MM -3  18594	HEAD FEMORAL 22MM +0  19003	HEAD FEMORAL 28MM-6  19004	HEAD FEMORAL 28MM-3  19005	HEAD FEMORAL 28MM+0  19006	HEAD FEMORAL 28MM+3  19007	HEAD FEMORAL 28MM+6  19008	HEAD FEMORAL 28MM+9  19053	HEAD FEMORAL 36MM -3  19054	HEAD FEMORAL 36MM +0  19055	HEAD FEMORAL 36MM +3  19056	HEAD FEMORAL 36MM +6  19057	HEAD FEMORAL 36MM +9  19130	HEAD FEMORAL 32MM-6  19131	HEAD FEMORAL 32MM-3  19132	HEAD FEMORAL 32MM+0  19133	HEAD FEMORAL 32MM +3  19134	HEAD FEMORAL 32MM+6  19135	HEAD FEMORAL 32MM +9

## 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.

## Distribution

US Domestic distribution to Texas and Michigan.

## Key facts

- **Recall number:** Z-0148-2026
- **Recalling firm:** BioPro, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-09
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Port Huron, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0148-2026

## Citation

> AI Analytics. FDA recall Z-0148-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0148-2026. Source: US FDA. Licensed CC0.

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