Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bard Monopty Disposable Core Biopsy Instruments and Kits Recalled by Bard Peripheral Vascular Inc Due to Bard Peripheral Vascular is recalling the Bard Monopty...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bard Peripheral Vascular Inc directly.
Affected Products
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.
Quantity: 29,342 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bard Peripheral Vascular Inc
Bard Peripheral Vascular Inc has 136 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report