CLASS II Device recall · Reported 22 Apr 2015 · FDA Enforcement Report
Bard Monopty Disposable Core Biopsy Instruments and Kits recalled
Bard Peripheral Vascular is recalling Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty, Product, distributed nationwide in the US. The recall was initiated on 17 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1447-2015
- FDA event ID
- 70733
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Mar 2015
- FDA classified
- 14 Apr 2015
- Reported
- 22 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Syringes & Needles
Timeline
| 17 Mar 2015 | Recall initiated by company | |
| 14 Apr 2015 | Classified by FDA | +28 days |
| 22 Apr 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.
Questions about this recall
Is Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty, Product recalled?
Yes. Bard Peripheral Vascular recalled Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty, Product on 17 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1447-2015.
Why was it 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.
Which lots are affected?
Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225.
Where was it sold?
Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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