# FDA recall Z-0149-2026

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

## Product

BioPro Endo Head (Metal uni-polar, 38-55)    Product Number/Description    10179	ENDO MD 38  10180	ENDO MD 41  10181	ENDO MD 43  10182	ENDO MD 45  10183	ENDO MD 47  10184	ENDO MD 49  10185	ENDO MD 51  10186	ENDO MD 53  10187	ENDO MD 55  10188	ENDO SH 38  10189	ENDO SH 41  10190	ENDO SH 43  10191	ENDO SH 45  10192	ENDO SH 47  10193	ENDO SH 49  10194	ENDO SH 51  10195	ENDO SH 53  10196	ENDO SH 55

## 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-0149-2026
- **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-0149-2026

## Citation

> AI Analytics. FDA recall Z-0149-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0149-2026. Source: US FDA. Licensed CC0.

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