FDA Device recall Z-1260-2023
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK
- FDA Device
- Class II
- ongoing
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class II recall of Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK by Bard Peripheral Vascular, citing the external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additiona….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1260-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-28 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Reason
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.
Identifiers
| code_info | REF/UDI-DI/Lot(Expiration Date): 1610MSK/00801741142567/1445630(11/28/2024), 1449980(12/28/2024), 1451134(1/28/2025);…REF/UDI-DI/Lot(Expiration Date): 1610MSK/00801741142567/1445630(11/28/2024), 1449980(12/28/2024), 1451134(1/28/2025); 1816MSK/00801741097065/1447510(12/28/2024), 1447511(12/28/2024), 1447512(12/28/2024), 1447513(12/28/2024), 1448118(12/28/2024), 1448119(12/28/2024), 1448120(12/28/2024), 1448121(12/28/2024), 1448743(12/28/2024), 1450413(12/28/2024), 1450414(12/28/2024), 1451075(1/28/2025), 1451076(1/28/2025), 1451621(1/28/2025), 1451622(1/28/2025), 1451625(1/28/2025), 1451626(1/28/2025), 1453516(1/28/2025), 1453517(1/28/2025), 1454295(1/28/2025), 1456850(2/28/2025), 1456856(2/28/2025), 1457030(2/28/2025) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1260-2023%22
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