Hologic, Inc recalls Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version…

Recall date

January 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1170-2025

FDA classification

Class II

Brand / firm

Hologic, Inc

Sold / distributed

Domestic: Nationwide Distribution

Why it was recalled

Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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