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Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Versi
Recalled February 19, 2025 · FDA recall Z-1170-2025 · Hologic
Hazard
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. · FDA Class II
Units
55,335 units
Sold at
Domestic: Nationwide Distribution
Description
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
Product
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Manufacturer(s)
Hologic, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →