BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01 — Class II medical device recall Z-3192-2024
Ongoing recall by Argon Medical Devices, Inc, reported 2024-10-02, distributed nationwide. Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may le
| Recall number | Z-3192-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2024-07-02 |
| Classified | 2024-09-20 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 95,430 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00886333004348, 00886333004355, 00886333004379, 00886333004386, 00886333006564, 00886333006571, 00886333006588, 00886333006601, 00886333006618, 00886333006625, 00886333006649, 00886333006656, 00886333006809, 00886333006816, 00886333224005, 00886333224012, 00886333224029, 00886333224036, 00886333224043, 00886333224050, 00886333224067, 00886333224074, 00886333224081, 00886333224098, 20886333004342 and 24 more |
| Model numbers | 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03, 763114100X, 763114200X, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X |
Product
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03; Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X
Reason for recall
Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
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-3192-2024. 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.