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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87316

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

Open FDA event record

Event summary

Timeline bucket
January 14, 2021
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 MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX Note - for definition of the "X's refer to Tyvek Lid Label.pdf" uploaded in Associated Documents

Z-1289-2021
Recall number
Z-1289-2021
Initiated
January 14, 2021
Classification
Class II
Status
Terminated
Quantity
Total 131,876 kits (102,210 kits U.S. and 29,666 kits O.U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.

Code information

Catalog and Product Description MQ1210 BARD MARQUEE Disposable Core Biopsy Instrument, 12g x 10cm, MQ1213 BARD MARQUEE Disposable Core Biopsy Instrument, 12g x 13cm, MQ1410 BARD MARQUEE Disposable Core Biopsy Instrument, 14g x 10cm, MQ1413 BARD MARQUEE Disposable Core Biopsy Instrument, 14g x 13cm, MQ1416 BARD MARQUEE Disposable Core Biopsy Instrument, 14g x 16cm, MQ1610 BARD MARQUEE Disposable Core Biopsy Instrument, 16g x 10cm, MQ1616 BARD MARQUEE Disposable Core Biopsy Instrument, 16g x 16cm, MQ1620 BARD MARQUEE Disposable Core Biopsy Instrument, 16g x 20cm, MQ1810 BARD MARQUEE Disposable Core Biopsy Instrument, 18g x 10cm, MQ1816 BARD MARQUEE Disposable Core Biopsy Instrument, 18g x 16cm, MQ1820 BARD MARQUEE Disposable Core Biopsy Instrument, 18g x 20cm, MQ1825 BARD MARQUEE Disposable Core Biopsy Instrument, 18g x 25cm, MQK1210 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 12g x 10cm, MQK1213 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 12g x 13cm, MQK1410 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 14g x 10cm, MQK1413 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 14g x 13cm, MQK1416 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 14g x 16cm, MQK1610 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 16g x 10cm, MQK1810 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 18g x 10cm, MQK1816 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 18g x 16cm, MQK1820 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 18g x 20cm, MQK1825 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 18g x 25cm, MQK2010 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 20g x 10cm, MQK2016 BARD MARQUEE Disposable Core Biopsy Instrument Kit, 20g x 16cm UDI Codes: (01)801741097119(17)230328(10)0001353340, (01)801741097119(17)230328(10)0001353342, (01)801741097119(17)230328(10)0001353401, (01)801741097119(17)230328(10)0001356645, (01)801741097119(17)230328(10)0001358065, (01)801741097119(17)230428(10)0001359983, (01)801741097119(17)230628(10)0001369253, (01)801741097126(17)230328(10)0001353402, (01)801741097126(17)230428(10)0001359984, (01)801741097126(17)230628(10)0001369256, (01)801741097133(17)230328(10)0001353403, (01)801741097133(17)230328(10)0001353404, (01)801741097133(17)230328(10)0001356410, (01)801741097133(17)230328(10)0001356409, (01)801741097133(17)230328(10)0001356886, (01)801741097133(17)230328(10)0001356888, (01)801741097133(17)230428(10)0001359150, (01)801741097133(17)230428(10)0001359152, (01)801741097133(17)230428(10)0001359149, (01)801741097133(17)230428(10)0001359151, (01)801741097133(17)230428(10)0001359988, (01)801741097133(17)230528(10)0001363603, (01)801741097133(17)230528(10)0001363604, (01)801741097133(17)230528(10)0001364078, (01)801741097133(17)230528(10)0001364076, (01)801741097133(17)230528(10)0001364077, (01)801741097133(17)230528(10)0001368474, (01)801741097133(17)230628(10)0001369045, (01)801741097133(17)230628(10)0001369046, (01)801741097140(17)230328(10)0001357081, (01)801741097140(17)230628(10)0001369273, (01)801741097157(17)230328(10)0001357079, (01)801741097164(17)230328(10)0001353246, (01)801741097164(17)230328(10)0001356414, (01)801741097164(17)230428(10)0001359989, (01)801741097164(17)230528(10)0001364079, (01)801741097164(17)230628(10)0001369264, (01)801741097171(17)230328(10)0001356999, (01)801741097171(17)230428(10)0001359990, (01)801741097188(17)230328(10)0001353723, (01)801741097195(17)230328(10)0001353492, (01)801741097195(17)230428(10)0001359991, (01)801741097195(17)230528(10)0001364091, (01)801741097195(17)230628(10)0001369267, (01)801741097201(17)230328(10)0001353722, (01)801741097218(17)230528(10)0001364092, (01)801741097218(17)230528(10)0001364093, (01)801741097218(17)230628(10)0001369270, (01)801741097225(17)230328(10)0001353721, (01)801741097225(17)230328(10)0001355807, (01)801741097225(17)230428(10)0001359994, (01)801741097225(17)230528(10)0001364090, (01)801741097263(17)230328(10)0001353400, (01)801741097263(17)230328(10)0001353399, (01)801741097263(17)230328(10)0001356646, (01)801741097263(17)230428(10)0001359178, (01)801741097263(17)230528(10)0001364069, (01)801741097263(17)230528(10)0001364070, (01)801741097263(17)230528(10)0001366667, (01)801741097263(17)230628(10)0001369252, (01)801741097263(17)230628(10)0001371860, (01)801741097270(17)230528(10)0001364072, (01)801741097270(17)230628(10)0001369259, (01)801741097287(17)230328(10)0001353727, (01)801741097287(17)230328(10)0001356411, (01)801741097287(17)230328(10)0001356412, (01)801741097287(17)230428(10)0001358408, (01)801741097287(17)230428(10)0001358409, (01)801741097287(17)230428(10)0001358414, (01)801741097287(17)230428(10)0001359999, (01)801741097287(17)230428(10)0001358413, (01)801741097287(17)230528(10)0001364084, (01)801741097287(17)230528(10)0001364085, (01)801741097287(17)230528(10)0001364082, (01)801741097287(17)230528(10)0001364080, (01)801741097287(17)230528(10)0001364081, (01)801741097287(17)230528(10)0001367194, (01)801741097287(17)230528(10)0001367195, (01)801741097287(17)230528(10)0001367196, (01)801741097287(17)230528(10)0001368556, (01)801741097287(17)230528(10)0001368555, (01)801741097287(17)230528(10)0001368760, (01)801741097287(17)230628(10)0001369292, (01)801741097294(17)230428(10)0001360001, (01)801741097300(17)230228(10)0001347094, (01)801741097300(17)230328(10)0001357065, (01)801741097317(17)230328(10)0001357859, (01)801741097317(17)230528(10)0001364088, (01)801741097317(17)230628(10)0001369278, (01)801741097348(17)230328(10)0001353725, (01)801741097348(17)230428(10)0001360028, (01)801741097348(17)230628(10)0001369289, (01)801741097355(17)230528(10)0001364089, (01)801741097355(17)230628(10)0001369284, (01)801741097362(17)230628(10)0001369290, (01)801741097379(17)230328(10)0001353724, (01)801741097379(17)230428(10)0001360029, (01)801741097386(17)230628(10)0001369272, (01)801741097393(17)230428(10)0001360030, (01)801741097393(17)230628(10)0001369276, Lot Numbers: 0001353340, 0001353342, 0001353401, 0001356645, 0001358065, 0001359983, 0001369253, 0001353402, 0001359984, 0001369256, 0001353403, 0001353404, 0001356410, 0001356409, 0001356886, 0001356888, 0001359150, 0001359152, 0001359149, 0001359151, 0001359988, 0001363603, 0001363604, 0001364078, 0001364076, 0001364077, 0001368474, 0001369045, 0001369046, 0001357081, 0001369273, 0001357079, 0001353246, 0001356414, 0001359989, 0001364079, 0001369264, 0001356999, 0001359990, 0001353723, 0001353492, 0001359991, 0001364091, 0001369267, 0001353722, 0001364092, 0001364093, 0001369270, 0001353721, 0001355807, 0001359994, 0001364090, 0001353400, 0001353399, 0001356646, 0001359178, 0001364069, 0001364070, 0001366667, 0001369252, 0001371860, 0001364072, 0001369259, 0001353727, 0001356411, 0001356412, 0001358408, 0001358409, 0001358414, 0001359999, 0001358413, 0001364084, 0001364085, 0001364082, 0001364080, 0001364081, 0001367194, 0001367195, 0001367196, 0001368556, 0001368555, 0001368760, 0001369292, 0001360001, 0001347094, 0001357065, 0001357859, 0001364088, 0001369278, 0001353725, 0001360028, 0001369289, 0001364089, 0001369284, 0001369290, 0001353724, 0001360029, 0001369272, 0001360030, 0001369276

Distribution pattern

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY O.U.S.: Australia, Belgium, Canada, Europe, India, and Singapore