Quick Facts at a Glance
- Recall Date
- September 9, 2025
- Hazard Level
- HIGH
- Brand
- BioPro
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, PREGNANT, 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
- Endo Head Ceramic Implant Component
- Model numbers
- 13006, 13012, 13013, 13019, 13007, 13008, 13009, 13010 +12 more
- Sold at
- Multiple Retailers
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 Endo Head ceramic components are used in dental implant procedures. These parts come in multiple sizes and IDs to fit different implants.
Why This Is Dangerous
A packaging defect could allow a breach in the sterile barrier, which may lead to infection if the device is implanted.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Implant surgeries may require scheduling changes. Patients could face infection risk if an affected device is implanted, and clinicians must coordinate replacements or testing as needed.
Practical Guidance
How to identify if yours is affected
- Check packaging integrity and look for any signs of compromised sterility.
- Do not implant if packaging is damaged or seal appears broken.
Where to find product info
FDA enforcement page and BioPro recall notice. The UDI-DI codes are listed with each model.
What timeline to expect
Recall communications with healthcare providers will occur within weeks. Replacements or refunds depend on the provider and BioPro.
If the manufacturer is unresponsive
- Escalate to hospital or clinic leadership.
- Contact FDA CDRH recall program if BioPro is unresponsive.
- Document all attempts to contact BioPro and the provider.
How to prevent similar issues
- Verify packaging integrity before use. Use products only from approved lots. Maintain recall watchlists for implant components.
- Ask suppliers for up-to-date sterilization and packaging standards.
- Keep UDI codes and model IDs documented for future recalls.
Documentation advice
Maintain all recall notices, packaging photos, device IDs, lot numbers, and correspondence with BioPro and healthcare providers.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 147 total units recalled
- All lots affected
- Reason: packaging could compromise sterile barrier
- Hazard: risk of infection if implanted in a patient
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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