Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core… — Class II medical device recall Z-2035-2023
Ongoing recall by Hologic, Inc, reported 2023-07-05, distributed nationwide. The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
| Recall number | Z-2035-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2023-05-02 |
| Classified | 2023-06-29 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 756 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 15420045504066 |
| Lot numbers | E22H19RM |
| Model numbers | SERTERA-14 |
Product
Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14
Reason for recall
The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery
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-2035-2023. 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.