Hologic, Inc. recalled 681,870 units of the Brevera Breast Biopsy System on December 15, 2025, due to presence of particulates that can enter breast tissue. The recall affects devices distributed nationwide in the U.S. Healthcare providers and patients must stop using the device immediately.
Presence of particulates in affected devices that can be deposited into breast tissue during use.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hologic, Inc or your healthcare provider for instructions. Notification method: Letter
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The Brevera Breast Biopsy System includes a Disposable 9 Gauge Needle. Model numbers affected are BREVDISP09 and UDI 1540045512863. The devices were distributed nationwide.
The affected devices contain particulates that may deposit into breast tissue during use. This poses a significant health risk to patients undergoing biopsy procedures.
No specific incidents were reported, but the potential for serious health complications exists due to contamination.
Stop using the Brevera Breast Biopsy System immediately. Contact Hologic, Inc. or your healthcare provider for further instructions.
For more information, call Hologic, Inc. at 1-800-123-4567 or visit their website at www.hologic.com.
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