FDA Device recall Z-0467-2025

Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210

• FDA Device
• Class II
• ongoing
• Published 2024-11-27

On 2024-11-27 the FDA classified a Class II recall of Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210 by Bard Peripheral Vascular, citing 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….

Read the official FDA Device notice

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

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

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All Bard Peripheral Vascular recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0467-2025%22

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