BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133
FDA device recall Z-0150-2026 · posted 2025-10-14 · Open, Classified
Recall details
- Recalling firm
- BioPro, Inc.
- 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.
- Action taken
- Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.
- Root cause
- Package design/selection
- Status
- Open, Classified
- Product code
- KWY
- Quantity affected
- 147 total
- Distribution
- US Domestic distribution to Texas and Michigan.
- Date initiated
- 2025-09-09
- Date posted
- 2025-10-14
- Location
- Port Huron, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOPRO POLAR HEAD (K100761) | Biopro, Inc. | 2010-12-03 |