What should I do if I have a recalled BioPro bipolar head?

Stop using the device immediately and contact your healthcare provider or BioPro for further instructions on the recall.

How can I identify if my bipolar head is affected by the recall?

Check the product ID on your device. Affected models range from 18130 to 18152.

What is the reason for the recall?

The recall is due to a potential packaging issue that may compromise the sterile barrier, increasing the risk of infection.

Are there any reported injuries associated with this recall?

No injuries or incidents have been reported related to this recall.

Where can I find more information about the recall?

You can find more details on the FDA website at the recall report link provided.

Who should I contact for a refund or replacement?

You should contact BioPro, Inc. directly for instructions on refunds or replacements.

Is it safe to use the BioPro bipolar head if it hasn't been opened?

No, stop using the device immediately if it is included in the recall, regardless of its sealed status.

How do I know if my device is part of the recall?

Verify the product ID and model number against the list provided in the recall information.

What is the hazard associated with the device?

The hazard is a potential loss of sterility that can lead to a risk of infection if the device is implanted.

What is the classification of this recall?

This recall is classified as Class II, indicating a potential risk where the use of the product may cause temporary or medically reversible adverse health consequences.

HIGHSeptember 9, 2025

BioPro Recalls 147 Bipolar Heads Over Sterility Risk — Check Your Model Numbers

BioPro recalled 147 bipolar heads due to a potential packaging issue that may compromise sterility. The defect could result in infection if the device is implanted. Patients and healthcare providers must stop using the device immediately and follow recall instructions.

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

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

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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.

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

147 units recalled
Models: 18130 to 18152
Defective packaging risk
Potential infection risk if implanted
Distributed in Texas and Michigan

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeBipolar Surgical Device

Product Details

Brand

BioPro

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