CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Endo Head (Ceramic) Product ID/Description 13006 Endo recalled by BioPro
BioPro is recalling Endo Head (Ceramic) Product ID/Description 13006 Endo Modular Ceramic SH 38 13012 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-0152-2026
- 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 (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
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 13006 M20913006 13012 M20913012 13013 M20913013 13019 M20913019 13007 M20913007 13008 M20913008 13009 M20913009 13010 M20913010 13011 M20913011 13014 M20913014 13015 M20913015 13016 M20913016 13017 M20913017 13018 M20913018 14823 M20914823 14824 M20914824 14825 M20914825 14826 M20914826 17295 M20917295 17296 M20917296 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 | Femoral Head Product ID/Description 14089 Head Femoral recalled | BioPro | Sterility | MI, TX | |
| CLASS II | Endo Head (Metal uni-polar, 38-55) Product recalled by BioPro | 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 | Endo Head (Metal uni-polar, 38-55) Product recalled by BioPro | BioPro | Sterility | MI, TX |
| Device | CLASS II | Femoral Head Product ID/Description 14089 Head Femoral recalled | 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 |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |