Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM — Class II medical device recall Z-1260-2023
Ongoing recall by Bard Peripheral Vascular Inc, reported 2023-03-22, distributed nationwide. The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, whi
| Recall number | Z-1260-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2023-02-28 |
| Classified | 2023-03-16 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, KR, TH, TW |
| Quantity | 38,635 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00801741097065, 00801741142567 |
| Model numbers | 1610MSK, 1816MSK |
Product
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Reason for recall
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.
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-1260-2023. 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.