Class II

Medical Device Recall: 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

Hologic, Inc · January 15, 2025

Reason for Recall

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

Distribution

Domestic: Nationwide Distribution

States Affected

NATIONWIDE

Quantity Affected

55,335 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1170-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Hologic, Inc Medical Device Recall: 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 | SafeCheck