Sertera Biopsy Device — Class II medical device recall Z-2869-2016
Terminated recall by Hologic, Inc, reported 2016-09-28, distributed nationwide. Incorrect label on the Sertera Biopsy Kit
| Recall number | Z-2869-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2016-08-22 |
| Classified | 2016-09-21 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2017-02-03 |
| Distributed | Nationwide (US) |
| Quantity | 570 units |
| Reason classes | labeling |
| Lot numbers | 15C10RA |
Product
Sertera Biopsy Device, Sterile; Used primarily in ultrasound-guided breast biopsies.
Reason for recall
Incorrect label on the Sertera Biopsy Kit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2869-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.