BioPro, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0151-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

BioPro Femoral Head (Ceramic heads 28-30) Product ID/Description 19023 HEAD FEMORAL CERAMIC 28MM -3 19024 HEAD FEMORAL CERAMIC 28MM +0 19025 HEAD FEMORAL CERAMIC 32MM -3 19026 HEAD FEMORAL CERAMIC 32MM +0 19027 HEAD FEMORAL CERAMIC 32MM +3

Product Classification:

Class II

Date Initiated: September 9, 2025

Date Posted: October 22, 2025

Recall Number: Z-0151-2026

Event ID: 97605

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.

Status: Ongoing

Product Quantity: 147 total

Code Information:

Product ID/UDI-DI 19023 M20919023 19024 M20919024 19025 M20919025 19026 M20919026 19027 M20919027 All lots, all serial numbers

Distribution Pattern:

US Domestic distribution to Texas and Michigan.

Voluntary or Mandated:

Voluntary: Firm initiated