Bard Monopty Disposable Core Biopsy Instruments and Kits — Class II medical device recall Z-1447-2015
Terminated recall by Bard Peripheral Vascular Inc, reported 2015-04-22, distributed nationwide. Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because the
| Recall number | Z-1447-2015 |
|---|---|
| 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 | 2015-03-17 |
| Classified | 2015-04-14 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2015-08-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | DK, ES, FI, FR, IE, IL, IT, JP, NL, PK, PL |
| Quantity | 29,342 units |
| Lot numbers | REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYK1575, REYL0042, REYL0126, REYL0523, REYL1225 |
Product
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410. The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). 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
Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.
Machine access
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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.