Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK — Class II medical device recall Z-1564-2023
Ongoing recall by Bard Peripheral Vascular Inc, reported 2023-05-17, distributed nationwide. Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of
| Recall number | Z-1564-2023 |
|---|---|
| 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 | 2023-04-11 |
| Classified | 2023-05-05 |
| Reported by FDA | 2023-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 4,120 |
| UPC / GTIN / UDI-DI | 00801741097089, 00801741097096 |
| Model numbers | 10CM, 16CM, 2010MSK, 2016MSK |
Product
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Reason for recall
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
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-1564-2023. 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.