Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sertera Biopsy Device Recalled by Hologic, Inc Due to Incorrect label on the Sertera Biopsy Kit
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc directly.
Affected Products
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Quantity: 570 units
Why Was This Recalled?
Incorrect label on the Sertera Biopsy Kit
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hologic, Inc
Hologic, Inc has 24 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report