BioPro recalled 147 bipolar heads on September 9, 2025, due to a potential packaging issue. The defect may compromise the sterile barrier, increasing infection risks if implanted. Healthcare providers and patients should stop using these 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 affects BioPro bipolar heads with model IDs from 18130 to 18152. These devices were distributed in Texas and Michigan. They are classified as Class II medical devices.
A packaging issue could compromise the sterile barrier of the bipolar heads. Loss of sterility may lead to potential infections for patients receiving these implants.
No specific incidents or injuries have been reported related to this recall. However, the potential for infection poses a significant risk.
Stop using the recalled devices immediately. Contact BioPro, Inc. or your healthcare provider for further instructions and recall details.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0150-2026 or contact BioPro directly.
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