Bard Monopty Disposable Core Biopsy Instruments Recalled for Activation Issues
Bard Peripheral Vascular is recalling specific Bard Monopty Disposable Core Biopsy Instruments and Kits due to potential activation-related issues.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (activation issues) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Bard Peripheral Vascular Inc is recalling Bard Monopty Disposable Core Biopsy Instruments and Kits. The affected products include Monopty 14g x 16cm (22mm), Monopty Biopsy, Monopty 14g x 10cm (22mm), and Monopty 14g x 10cm (11mm). The recall involves 29,342 units distributed worldwide, including the United States and several countries in Europe, Asia, and the Middle East.
The recall is being conducted because the devices may be at risk of having activation-related issues. The Bard Monopty Disposable Core Biopsy Instrument is a single-use device intended for obtaining biopsies from soft tissues such as the liver, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. It is not intended for use in bone.
The specific lot numbers affected are REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, and REYL1225. Healthcare providers and facilities should check their inventory for these specific product codes and lot numbers.
The recalled product
- 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 B
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 29,342
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- Lot Number: REYK1575
- REYL0126
- REYI1423
- REYI2144
- REYI2147
- REYI2257
- REYI2259
- REYJ0186
- REYJ0652
- REYJ1221
- REYJ2078
- REYK0399
- REYK0794
- REYK1112
- REYK1573
- REYL0042
- REYL0523
- REYL1225.
Distribution
Distributed nationwide across the United States.
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