BARD MARQUEE Disposable Core Biopsy Instruments XX — Class II medical device recall Z-1289-2021
Terminated recall by Bard Peripheral Vascular Inc, reported 2021-03-31, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft
| Recall number | Z-1289-2021 |
|---|---|
| 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 | 2021-01-14 |
| Classified | 2021-03-22 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2025-01-28 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AU, BE, CA, IN, SG |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00801741097119, 00801741097126, 00801741097133, 00801741097140, 00801741097157, 00801741097164, 00801741097171, 00801741097188, 00801741097195, 00801741097201, 00801741097218, 00801741097225, 00801741097263, 00801741097270, 00801741097287, 00801741097294, 00801741097300, 00801741097317, 00801741097348, 00801741097355, 00801741097362, 00801741097379, 00801741097386, 00801741097393 |
| Lot numbers | 0001347094, 0001353246, 0001353340, 0001353342, 0001353399, 0001353400, 0001353401, 0001353402, 0001353403, 0001353404, 0001353492, 0001353721, 0001353722, 0001353723, 0001353724, 0001353725, 0001353727, 0001355807, 0001356409, 0001356410, 0001356411, 0001356412, 0001356414, 0001356645, 0001356646, 0001356886, 0001356888, 0001356999, 0001357065, 0001357079, 0001357081, 0001357859, 0001358065, 0001358408, 0001358409, 0001358413, 0001358414, 0001359149, 0001359150, 0001359151 and 60 more |
Product
BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents
Reason for recall
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
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-1289-2021. 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.