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FDAMay 2, 2023device

Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery

What to do

FDA enforcement status: Ongoing

Brands named

hologic

UPCs

15420045504066

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14 — Recall Details · AllClear