CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Femoral Head (Metal 22, 28, 32, 36, cobalt chromium recalled by BioPro
BioPro is recalling Femoral Head (Metal 22, 28, 32, 36, cobalt chromium and ceramic heads Part, 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-0148-2026
- 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
- Hip & Knee Implants
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 Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9
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?
Part ID/ UDI-DI: 18593 M20918593 18594 M20918594 19003 M20919003 19004 M20919004 19005 M20919005 19006 M20919006 19007 M20919007 19008 M20919008 19053 M20919053 19054 M20919054 19055 M20919055 19056 M20919056 19057 M20919057 19130 M20919130 19131 M20919131 19132 M20919132 19133 M20919133 19134 M20919134 19135 M20919135 All lots and serial numbers affected
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 | 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 | 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 | Endo Head (Ceramic) Product ID/Description 13006 Endo recalled by BioPro | BioPro | Sterility | MI, TX |
| Device | CLASS II | Bipolar Head Product ID/Description 18130 Bipolar Head recalled | BioPro | Sterility | MI, TX |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |