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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70733

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
March 17, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Bard Peripheral Vascular Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-1447-2015
Recall number
Z-1447-2015
Initiated
March 17, 2015
Classification
Class II
Status
Terminated
Quantity
29,342 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Number: REYK1575, REYL0126, REYI1423, REYI2144, REYI2147, REYI2257, REYI2259, REYJ0186, REYJ0652, REYJ1221, REYJ2078, REYK0399, REYK0794, REYK1112, REYK1573, REYL0042, REYL0523, REYL1225.

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.