BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x… — Class II medical device recall Z-1586-2015
Terminated recall by Bard Peripheral Vascular Inc, reported 2015-05-13, distributed nationwide. The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activatio
| Recall number | Z-1586-2015 |
|---|---|
| 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 | 2015-04-09 |
| Classified | 2015-05-06 |
| Reported by FDA | 2015-05-13 |
| Terminated | 2015-09-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CN, DE, ES, FI, FR, GB, GR, IS, IT, JP, KR, MX, NL, NO, PA, PL, SG, TW |
| Quantity | 7,995 units |
| Lot numbers | REYA2017, REYC2853 |
Product
BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge.
Reason for recall
The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
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-1586-2015. 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.