Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 Recalled by BioPro, Inc. Due to Potential packaging issue that could compromise the sterile...

Date: September 9, 2025
Company: BioPro, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact BioPro, Inc. directly.

Affected Products

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

Quantity: 147 total

Why Was This Recalled?

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.

Where Was This Sold?

US Domestic distribution to Texas and Michigan.

About BioPro, Inc.

BioPro, Inc. has 37 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report