BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 1018...
FDA Recall #Z-0149-2026 — Class II — September 9, 2025
Product Description
BioPro Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 ENDO SH 43 10191 ENDO SH 45 10192 ENDO SH 47 10193 ENDO SH 49 10194 ENDO SH 51 10195 ENDO SH 53 10196 ENDO SH 55
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.
Recalling Firm
BioPro, Inc. — Port Huron, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
147 total
Distribution
US Domestic distribution to Texas and Michigan.
Code Information
Product ID/UDI-DI 10179 M20910179 10180 M20910180 10181 M20910181 10182 M20910182 10183 M20910183 10184 M20910184 10185 M20910185 10186 M20910186 10187 M20910187 10188 M20910188 10189 M20910189 10190 M20910190 10191 M20910191 10192 M20910192 10193 M20910193 10194 M20910194 10195 M20910195 10196 M20910196 All lots, all serial numbers
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated