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
- Bipolar Surgical Device
- Model numbers
- 18130, 18131, 18132, 18133, 18134, 18135, 18136, 18137 +15 more
- 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
The BioPro Bipolar Head is a specialized medical device used in electrosurgery to cut and coagulate tissue. Healthcare providers depend on the sterilization integrity of these devices to prevent infections during surgical procedures.
Why This Is Dangerous
The potential packaging issue can lead to the device losing its sterile barrier, which increases the risk of infection if implanted in a patient.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act quickly to prevent the risk of infection associated with the use of potentially contaminated devices.
Practical Guidance
How to identify if yours is affected
- Check the product ID on the device packaging.
- Verify if your model is between 18130 and 18152.
- Review any recent communications from BioPro regarding the recall.
Where to find product info
Serial numbers and product IDs can usually be found on the packaging or labeling of the device.
What timeline to expect
Expect a refund or replacement processing time of 4-8 weeks.
If the manufacturer is unresponsive
- Document your communications with BioPro.
- Contact the FDA if you do not receive a response within a reasonable time.
How to prevent similar issues
- Check for FDA recalls before purchasing medical devices.
- Ensure that the packaging of medical devices is intact and sterile upon receipt.
Documentation advice
Keep records of your purchase, including receipts and any correspondence related to the recall.
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Product Details
Product IDs: 18130 (38MM) through 18152 (60MM). Total quantity: 147 units. Distributed in Texas and Michigan.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Defective packaging risk
- Potential infection risk if implanted
- Distributed in Texas and Michigan
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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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