Bard Peripheral Vascular Inc: Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF: MQK1210; BARD MARQUEE 12G X 10 CM, REF: MQ1210; BARD MARQUEE Kit 12G X 13 CM, REF:

Hazard

Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding.

Details from the source

Reason for recall: Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could lead to needle detachment and misplacement, which could lead to tissue damage and bleeding. Distribution: Worldwide - US Nationwide including in the states of WA, LA, MN, PA, UT, SC, OK, KY, AZ, IL, TX, NJ, NY, FL, TN, IN, OH, NC, CO, VA, GA, MD, CA, AL, WI, MO, IA, CT, NE, MI, MS, NV, KS, OR, SD, ID, NH, RI, WY, AR, MA, DE, ND, NM, AK, PR and the countries of Portugal, Spain, South Africa, Greece, United Arab Emirates, United Kingdom, Sweden, Finland, Belgium, Korea, Australia, Canada. Quantity: 71,498 Lot/code info: REF/UDI-DI/Lot(Expiration): MQK1210/00801741097263/1490758(9/28/2025), 1506044(1/28/2026), 1506045(1/28/2026), 1511827(2/28/2026), 1514692(3/28/2026), 1518977(4/28/2026), 1518978(4/28/2026), 1518979(4/28/2026), 1519143(4/28/2026), 1520507(5/28/2026), 1520508(5/28/2026), 1522157(5/28/2026), 1522158(5/28/2026), 1522577(5/28/2026), 1523785(6/28/2026), 1523914(6/28/2026), 1523915(6/28/2026), 1525370(6/28/2026), 1525371(6/28/2026), 1525373(6/28/2026), 1528417(7/28/2026), 1528418(7/28/2026), 1528495(7/28/2026), 1528496(7/28/2026), 1528497(7/28/2026), 1528560(7/28/2026), 0001618867(3/28/2028), 0001620281(3/28/2028), 0001632675(6/28/2028); MQ1210/00801741097119/1514460(3/28/2026), 1514461(3/28/2026), 1519144(4/28/2026), 1519145(4/28/2026), 1519456(4/28/2026), 1520066(5/28/2026), 1520067(5/28/2026), 1520506(5/28/2026), 1523783(6/28/2026), 1523784(6/28/2026), 0001618258(3/28/2028), 0001631611(6/28/2028), 0001633216(7/28/2028); MQK1213/00801741097270/1543517(10/28/2026), 1559312(2/28/2027), 1562724(3/28/2027), 1569737(4/28/2027), 1581652(7/28/2027); MQ1213/00801741097126/1558191(2/28/2027), 1559313(2/28/2027)

UPC codes

00801741097263, 00801741097119, 00801741097270, 00801741097126

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.