Quick Facts at a Glance
- Recall Date
- September 9, 2025
- Hazard Level
- HIGH
- Brand
- BioPro
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- BioPro
- Product type
- Hip Implant - Femoral Head
- Model numbers
- 14089 M20914089, 14090 M20914090, 14091 M20914091, 14094 M20914094, 14095 M20914095, 14096 M20914096, All lots, All serial numbers
- Sold at
- Unknown
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 9, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact BioPro, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
BioPro Femoral Head components are used in hip replacement procedures. The devices are supplied as part of total hip arthroplasty implants and are intended for use by surgeons in operating rooms.
Why This Is Dangerous
A packaging defect could fail to preserve the sterile barrier. If a device is implanted and sterility is compromised, there is a risk of postoperative infection.
Industry Context
This recall is not described as part of a broader industry pattern in the provided information.
Real-World Impact
The immediate impact is a halt in use of the affected devices and coordination between BioPro and healthcare providers to identify and replace affected lots. The recall could affect patient care decisions and hospital inventories.
Practical Guidance
How to identify if yours is affected
- Verify UDI-DI codes M20914089 through M20914096.
- Confirm packaging status and lot numbers on the device package.
- If affected, stop using the device immediately and contact BioPro or the treating clinician.
Where to find product info
UDI-DI or model IDs are often printed on the device packaging and accompanying documentation. Use the recall notice for exact identifiers.
What timeline to expect
Recall processing and replacement coordination typically occur within weeks to a couple of months, depending on facilities and patient conditions.
If the manufacturer is unresponsive
- Contact your hospital's risk manager or purchasing department.
- File a report with the FDA if you believe patient safety is at risk.
How to prevent similar issues
- Verify supplier recalls before accepting devices for use.
- Maintain up-to-date inventory of implants and cross-check with recall notices.
- Require validated sterile packaging checks before implantation.
Documentation advice
Keep all recall communications, device identifiers, and correspondence with BioPro and healthcare providers. Document actions taken and retain packaging for evidence.
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Product Details
Product IDs: 14089, 14090, 14091, 14094, 14095, 14096. UDI-DI mappings: 14089 M20914089, 14090 M20914090, 14091 M20914091, 14094 M20914094, 14095 M20914095, 14096 M20914096. All lots and all serial numbers are affected. Quantity: 147 units. US distribution: Texas and Michigan. Recall date: 2025-09-09. Report date: 2025-10-22. Manufacturer: BioPro, Inc. Status: ACTIVE.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 147 total units recalled
- All lots and all serial numbers affected
- US distribution limited to Texas and Michigan
- Recall date 2025-09-09; Report date 2025-10-22
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Safety Guide
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