BioPro recalled 147 units of Endo Heads on September 9, 2025. A packaging issue may compromise the sterile barrier, leading to infection risk. Healthcare providers and patients should stop using the devices immediately.
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.
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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The recall involves BioPro Endo Heads with product IDs including 13006, 13012, 13013, and others. These devices were distributed in Texas and Michigan. The devices were sold domestically.
The recall stems from a potential packaging defect that may compromise the sterile barrier of the devices. If the sterility is lost, there is a significant risk of infection during implantation.
No specific incidents or injuries have been reported related to this recall. However, the potential for infection poses a serious health risk.
Patients and healthcare providers must stop using the Endo Heads immediately. Contact BioPro, Inc. or your healthcare provider for further instructions and follow the recall guidelines provided.
For more information, contact BioPro, Inc. directly or visit their official website. Additional details can also be found through the FDA's recall announcement.
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