Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT… — Class II medical device recall Z-0467-2025
Ongoing recall by Bard Peripheral Vascular Inc, reported 2024-11-27, distributed nationwide. Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the
| Recall number | Z-0467-2025 |
|---|---|
| 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 | 2024-09-30 |
| Classified | 2024-11-15 |
| Reported by FDA | 2024-11-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, CA, ES, FI, GB, GR, KR, PT, SE, ZA |
| Quantity | 71,498 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00801741097119, 00801741097126, 00801741097263, 00801741097270 |
| Model numbers | MQ1210, MQ1213, MQK1210, MQK1213 |
Product
Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF: MQK1213; BARD MARQUEE 12G X 13 CM, REF: MQ1213
Reason for recall
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 device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.
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-0467-2025. 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.