FDA Medical Device Recalls (openFDA)
Hologic, Inc: Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
- Recall number
- Z-2869-2016
- Recalling firm
- Hologic, Inc
- Product
- Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
- Status
- Terminated
- Initiated
- 2016-08-22
- Posted
- 2016-09-21
- Terminated
- 2017-02-03
- Reason
- Incorrect label on the Sertera Biopsy Kit
- 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
- 570 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot number: 15C10RA.
- 510(k) numbers
- ["K150169"]
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 1000120743
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28