BioPro, Inc. recalls BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 130…

Recall date

September 9, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0152-2026

FDA classification

Class II

Brand / firm

BioPro, Inc.

Sold / distributed

US Domestic distribution to Texas and Michigan.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36