Recall Z-0153-2026— BioPro, Inc.

Name: FDA recall Z-0153-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-09

Class II · Ongoing

Class II FDA medical device recall by BioPro, Inc., initiated 2025-09-09. It names one FDA 510(k) clearance: K872856. Product: BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT. Reason: 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..

Recalling firm: BioPro, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-09
Firm location: Port Huron, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K872856 — BIOPRO 32MM BALLBiopro, Inc.·cleared 1987-08-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.