Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 22, 2015
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Bard Peripheral Vascular Inc recalled Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Prod… - a moderate-severity action.
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Prod… was recalled by Bard Peripheral Vascular Inc in April 22, 2015. Reason: Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because th…. Check the official notice for the remedy. Verify recall #Z-1447-2015 with the FDA Devices before acting.
The recall
Bard Peripheral Vascular Inc issued this moderate-severity FDA Devices recall-Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because th….
- Moderate
- severity level
- 29K units
- affected scope
- Class II
- classification
- April 22, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1447-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1447-2015) was formally reported on April 22, 2015, with the manufacturer initiating the action on March 17, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Bard Peripheral Vascular Inc is listed as the recalling firm, operating out of Tempe, AZ. Federal records list the affected scope as 29,342 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
29,342 units
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1447-2015 |
| Date reported | April 22, 2015 |
| Date initiated | March 17, 2015 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Firm location | Tempe, AZ |
| Affected scope | 29,342 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1447-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Bard Peripheral Vascular Inc. Units affected: 29,342 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on April 22, 2015. Severity: Moderate. Recall number: Z-1447-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1447-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 22, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.