Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device… — Class II medical device recall Z-1170-2025
Ongoing recall by Hologic, Inc, reported 2025-02-19, distributed nationwide. Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of
| Recall number | Z-1170-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2025-01-15 |
| Classified | 2025-02-13 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Quantity | 55,335 units |
| UPC / GTIN / UDI-DI | 15420045504066 |
| Lot numbers | E23B23RL, E23B23RM, E23C07RD, E23C07RF, E23C31RC, E23D12RT, E23D12RU, E23D27RW, E23E03RJ, E23E12RT, E23E12RU, E23E29RL, E23E30RM, E23F02RG, E23F07RL, E23F07RM, E23F27R, E23F29RL, E23F29RM, E23F29RN, E23G12RK, E23G25R, E23G31RL, E23H02R, E23H02RA, E23H02RB, E23H28RA, E23H31RF, E23H31RG, E23K02RL, E23K10R, E23K10RA, E23K10RB, E23K31RU, E23L06RK, E23L10RB, E23L22RV, E23L28RB, E23L28RD, E23M21RV and 16 more |
| Model numbers | SERTERA-14 |
Product
Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog Number: Sertera-14 Software Version: N/A Product Description: Instrument, Biopsy Component: N/A
Reason for recall
Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement.
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-1170-2025. 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.