Recall Z-0149-2026— BioPro, Inc.

Name: FDA recall Z-0149-2026
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: K895886. Product: 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: 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

K895886 — BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEMBiopro, Inc.·cleared 1989-12-01

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 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.

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