CLASS II Device recall · Reported 31 Mar 2021 · FDA Enforcement Report
Bard Marquee Disposable Core Biopsy Instruments XX.Xcm recalled
Bard Peripheral Vascular is recalling Bard Marquee Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm, distributed in 52 states. The recall was initiated on 14 Jan 2021 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-1289-2021
- FDA event ID
- 87316
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2021
- FDA classified
- 22 Mar 2021
- Reported
- 31 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Jan 2021 | Recall initiated by company | |
| 22 Mar 2021 | Classified by FDA | +67 days |
| 31 Mar 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
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
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Bard Marquee Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm recalled?
Yes. Bard Peripheral Vascular recalled Bard Marquee Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm on 14 Jan 2021. The recall is Class II and its status is Terminated. Recall number Z-1289-2021.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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
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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