# FDA recall Z-0153-2026

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

## 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.

## Distribution

US Domestic distribution to Texas and Michigan.

## Key facts

- **Recall number:** Z-0153-2026
- **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-0153-2026

## Citation

> AI Analytics. FDA recall Z-0153-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0153-2026. Source: US FDA. Licensed CC0.

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