BARD MAX-CORE Disposable Core Biopsy Instrument — Class II medical device recall Z-0724-2020
Terminated recall by Bard Peripheral Vascular Inc, reported 2020-01-01, distributed nationwide. During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrume
| Recall number | Z-0724-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2019-10-25 |
| Classified | 2019-12-20 |
| Reported by FDA | 2020-01-01 |
| Terminated | 2024-04-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 727,034 units |
| UPC / GTIN / UDI-DI | 00801741084423, 00801741084430, 00801741084447, 00801741084454, 00801741084461, 00801741084478, 00801741084485, 00801741084492, 00801741084515, 00801741084522 |
Product
BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Reason for recall
During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.
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-0724-2020. 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.