# FDA recall Z-0150-2026

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

## Product

BioPro Bipolar Head    Product ID/Description  18130	BIPOLAR HEAD 38MM  18131	BIPOLAR HEAD 39MM  18132	BIPOLAR HEAD 40MM  18133	BIPOLAR HEAD 41MM  18134	BIPOLAR HEAD 42MM  18135	BIPOLAR HEAD 43MM  18136	BIPOLAR HEAD 44MM  18137	BIPOLAR HEAD 45MM  18138	BIPOLAR HEAD 46MM  18139	BIPOLAR HEAD 47MM  18140	BIPOLAR HEAD 48MM  18141	BIPOLAR HEAD 49MM  18142	BIPOLAR HEAD 50MM  18143	BIPOLAR HEAD 51MM  18144	BIPOLAR HEAD 52MM  18145	BIPOLAR HEAD 53MM  18146	BIPOLAR HEAD 54MM  18147	BIPOLAR HEAD 55MM  18148	BIPOLAR HEAD 56MM  18149	BIPOLAR HEAD 57MM  18150	BIPOLAR HEAD 58MM  18151	BIPOLAR HEAD 59MM  18152	BIPOLAR HEAD 60MM

## 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-0150-2026
- **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-0150-2026

## Citation

> AI Analytics. FDA recall Z-0150-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0150-2026. Source: US FDA. Licensed CC0.

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