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Hologic, Inc recalls Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the br
Recalled July 5, 2023 · FDA recall Z-2035-2023 · Hologic
Hazard
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery · FDA Class II
Units
756 units
Sold at
US Nationwide distribution.
Description
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
Product
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Manufacturer(s)
Hologic, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →