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, PREGNANT
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
- Femoral Head
- Model numbers
- 18593, 18594, 19003, 19004, 19005, 19006, 19007, 19008 +11 more
- Sizes
- 22, 28, 32, 36, 40
- 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. They are available in metal cobalt chromium and ceramic variants and come in multiple sizes to fit patient anatomy.
Why This Is Dangerous
A packaging defect could allow the sterile barrier to be compromised, risking infection if implanted.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Hospitals and surgical teams must verify sterile packaging integrity. Potential infection risk could prompt reoperations or delays in treatment.
Practical Guidance
How to identify if yours is affected
- Review recall notice for part IDs and sizes
- Cross-check hospital inventory or supply chain records
- Consult surgical teams to determine if any affected parts were used
Where to find product info
Part IDs and distribution details are in the recall listing and FDA enforcement report
What timeline to expect
Replacement and refund timelines are determined by BioPro; refer to the recall notice for next steps
If the manufacturer is unresponsive
- Escalate to hospital supply chain management
- Document all communications with BioPro
- File a consumer safety complaint with the FDA if manufacturer guidance stalls
How to prevent similar issues
- Request supplier verification of sterile packaging integrity for hip prosthesis components
- Adopt strict receiving inspection procedures for implants
- Verify lot numbers and date codes before implantation
Documentation advice
Keep copies of the recall notice, supplier communications, and surgical records related to implants
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Product Details
Brand: BioPro. Product: Femoral Head components (Metal 22, 28, 32, 36, 40; cobalt chromium and ceramic). Part IDs include 18593 through 19135 with multiple ±/+ size variants. Quantity: 147 total units. Distribution: US Domestic to Texas and Michigan. Date recalled: 2025-09-09. Date reported: 2025-10-22.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 147 total units recalled
- Sizes include 22, 28, 32, 36, 40 mm
- Metal cobalt chromium and ceramic head variants
- Distribution limited to Texas and Michigan in the US
- Recall date 2025-09-09; report date 2025-10-22
- High hazard level due to potential loss of sterility
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Safety Guide
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