Sertera Biopsy Device, Sterile recallZ-2869-2016 · Hologic, Inc · initiated Aug 22, 2016
Class II Terminated All recalls posted in September 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Hologic, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect label on the Sertera Biopsy Kit
FDA root cause category: Labeling Change Control
What the company is doing
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 ).
Recall details
- Recall number
- Z-2869-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 22, 2016
- Posted by the FDA
- Sep 21, 2016
- Recalling firm
- Hologic, Inc
- Quantity
- 570 units
- Product code
- KNW
- FDA submissions
- K150169
- Distribution
- Nationwide.
Product description
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Code information (models, lots, serial numbers)
Lot number: 15C10RA.
Other devices under the same FDA submission
2 devices cleared under K150169 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Sertera Biopsy Device Sertera-14Hologic, Inc. · INSTRUMENT, BIOPSY2 recalls14 reports
- Sertera Biopsy Device Sertera-12Hologic, Inc. · INSTRUMENT, BIOPSY2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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