Hologic, Inc: Medical Device Recall in 2016 - (Recall #: Z-2869-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.

Product Classification:

Class II

Date Initiated: August 22, 2016

Date Posted: September 28, 2016

Recall Number: Z-2869-2016

Event ID: 74989

Reason for Recall:

Incorrect label on the Sertera Biopsy Kit

Status: Terminated

Product Quantity: 570 units

Code Information:

Lot number: 15C10RA.

Distribution Pattern:

Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated