Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy Recalled by Hologic, Inc Due to The inner needle of the Sertera device is...
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 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Quantity: 756 units
Why Was This Recalled?
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
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