Z-2869-2016Class II

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

Name: Z-2869-2016 Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies
Creator: Hologic, Inc
Published: 2016-08-22
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2016-08-22 / Terminated / root cause: labeling and UDI

FDA source

Hologic, Inc began a recall of Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies on 2016-08-22. FDA classified it as Class II and gives the reason as "Incorrect label on the Sertera Biopsy Kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2869-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-22
Posted: 2016-09-21
Terminated: 2017-02-03
Recalling firm: Hologic, Inc.
Product: Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Product code: KNW Instrument, Biopsy
Reason for recall: Incorrect label on the Sertera Biopsy Kit
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Hologic notified customers in the United States through Certified letter on 8/22/16. The letter contains instructions of returning the product, provides contact information, and includes a postage-paid return card for the consignee to complete and return to Hologic. Contact technical support at 508-263-2900 or l-800-442:9892 Press Option 6 ).
Quantity in commerce: 570 units
Distribution: Nationwide.
Product codes and lots: Lot number: 15C10RA.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2869-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2869-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-21

Product code KNW

K150169Class IISertera Biopsy DeviceHologic, Inc. / cleared 2015-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)