# FDA recall Z-0152-2026

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

## Product

BioPro Endo Head (Ceramic)    Product ID/Description  13006	ENDO MODULAR CERAMIC SH 38  13012	ENDO MODULAR CERAMIC SH 51  13013	ENDO MODULAR CERAMIC MD 38  13019	ENDO MODULAR CERAMIC MD 51  13007	ENDO MODULAR CERAMIC SH 41  13008	ENDO MODULAR CERAMIC SH 43  13009	ENDO MODULAR CERAMIC SH 45  13010	ENDO MODULAR CERAMIC SH 47  13011	ENDO MODULAR CERAMIC SH 49  13014	ENDO MODULAR CERAMIC MD 41  13015	ENDO MODULAR CERAMIC MD 43  13016	ENDO MODULAR CERAMIC MD 45  13017	ENDO MODULAR CERAMIC MD 47  13018	ENDO MODULAR CERAMIC MD 49  14823	ENDO MODULAR CERAMIC SH 53  14824	ENDO MODULAR CERAMIC MD 53  14825	ENDO MODULAR CERAMIC SH 55  14826	ENDO MODULAR CERAMIC MD 55  17295	ENDO MODULAR CERAMIC SH 36  17296	ENDO MODULAR CERAMIC MD 36

## 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-0152-2026
- **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-0152-2026

## Citation

> AI Analytics. FDA recall Z-0152-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0152-2026. Source: US FDA. Licensed CC0.

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