Recall Z-2035-2023— Hologic, Inc

Name: FDA recall Z-2035-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-02

Class II · Ongoing

Class II FDA medical device recall by Hologic, Inc, initiated 2023-05-02. It names one FDA 510(k) clearance: K150169. Product: Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14. Reason: The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery.

Recalling firm: Hologic, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-05-02
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K150169 — Sertera Biopsy DeviceHologic, Inc.·cleared 2015-08-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.