CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Endo Head (Metal uni-polar, 38-55) Product recalled by BioPro
BioPro is recalling Endo Head (Metal uni-polar, 38-55) Product Number/Description 10179 Endo MD 38 10180 Endo, distributed in Michigan, Texas. The recall was initiated on 9 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0149-2026
- FDA event ID
- 97605
- Recalling firm
- BioPro, Port Huron, MI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Sep 2025
- FDA classified
- 14 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 9 Sep 2025 | Recall initiated by company | |
| 14 Oct 2025 | Classified by FDA | +35 days |
| 22 Oct 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Domestic distribution to Texas and Michigan.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Domestic distribution to Texas and Michigan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97605This product is part of a recall event; the main page for the event is Bipolar Head Product ID/Description 18130 Bipolar Head recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bipolar Head Product ID/Description 18130 Bipolar Head recalled | BioPro | Sterility | MI, TX | |
| CLASS II | Femoral Head (Metal 22, 28, 32, 36, cobalt chromium recalled by BioPro | BioPro | Sterility | MI, TX | |
| CLASS II | Endo Head (Ceramic) Product ID/Description 13006 Endo recalled by BioPro | BioPro | Sterility | MI, TX | |
| CLASS II | Femoral Head Product ID/Description 14089 Head Femoral recalled | BioPro | Sterility | MI, TX | |
| CLASS II | Femoral Head (Ceramic heads 28-30) Product ID/Description recalled | BioPro | Sterility | MI, TX |
More recalls from BioPro
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Femoral Head (Ceramic heads 28-30) Product ID/Description recalled | BioPro | Sterility | MI, TX |
| Device | CLASS II | Femoral Head Product ID/Description 14089 Head Femoral recalled | BioPro | Sterility | MI, TX |
| Device | CLASS II | Endo Head (Ceramic) Product ID/Description 13006 Endo recalled by BioPro | BioPro | Sterility | MI, TX |
| Device | CLASS II | Femoral Head (Metal 22, 28, 32, 36, cobalt chromium recalled by BioPro | BioPro | Sterility | MI, TX |
| Device | CLASS II | Bipolar Head Product ID/Description 18130 Bipolar Head recalled | BioPro | Sterility | MI, TX |
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