FDA recall Z-1170-2025

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

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

Key facts

Status

Ongoing

Initiation date

2025-01-15

Report date

2025-02-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1170-2025