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UNIVERSAL DUO
MEDAX SRL UNIPERSONALE · Model UD14160-0P · UDI-DI 08055002909686
KNW
Prescription
1
510(k) clearances
23,838
Adverse events (27 deaths)
106
Recalls
203
Facilities
Description
Soft tissue biopsy needle mod. U.DUO, 14G x 160 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2025-12-15 | Hologic, Inc | Presence of particulates in affected devices that can be deposited into breast tissue during use. |
| 2025-01-15 | Hologic, Inc | Devices presented a condition in which the inner needle separated from the hub and produced a longer throw of the inner needle or dislodgement. |
| 2024-09-30 | Bard Peripheral Vascular Inc | Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the d |
| 2024-07-02 | Argon Medical Devices, Inc | 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 |
| 2023-11-08 | Bard Peripheral Vascular Inc | The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on |
| 2023-08-10 | Bard Peripheral Vascular Inc | Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needl |
| 2023-05-02 | Hologic, Inc | The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.