Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.
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📍Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1 · Tempe, AZ 85281-2438
✎ GovInfoNow plain-language explainer
Bard is recalling disposable core biopsy kits with reference number MQK2016 because the needle may not fit properly into the cannula, leading to repeated procedures and risks like pain, pneumothorax, or bleeding. This affects medical professionals using the kits for biopsies. Read more at govinfonow.com/recall/57507-bard-marquee-disposable-core-biopsy-kit-diameter-mismatch-risk.
“Bard Marquee Disposable Core Biopsy Kit: Diameter Mismatch Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57507-bard-marquee-disposable-core-biopsy-kit-diameter-mismatch-risk. Based on FDA recall #Z-0027-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0027-2024%22&limit=1).
Bard Peripheral Vascular Inc. recalled the Bard Marquee Disposable Core Biopsy Instrument Kit (REF: MQK2016) due to a diameter mismatch that may cause procedural complications, according to the FDA on 2023-08-10.
The coaxial cannula inner diameter prohibits the biopsy needle from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.
Context
GovInfoNow's records show Bard Peripheral Vascular Inc. has 40 other recalls on record since 2017-09-22. Other recent recalls of similar products include Bard Breast Biopsy System May Cause Procedure Interruptions (2026-08-20) and Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall: Erroneous Safety Indicator Risk (2025-11-06). Other recent recalls of similar products include Bard Soft Tissue Biopsy Trays Recall: Lidocaine Ampoule Manufacturing Deficiency (2026-05-21) and Medline Recalls Olympus Biopsy Kits: Risk of Foreign Body in Patient Airway (2026-02-16).
How to tell if you have this one
Check for the reference number MQK2016 on the kit. The kit was sold with UDI-DI: 00801741097393 and Lot: 0001480774, expiring July 28, 2025.
Brand
Bard
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for reference number MQK2016 on the kit label or packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of PR, CO, TX, CA, WA, OR, AZ, NJ, NY, OH, NC, MD, MI, LA, IN, AK, TN and the countries of CA, AU, BE.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alaska, Arizona, California, Colorado, Indiana, Louisiana, Maryland, Michigan, New Jersey, New York, North Carolina, Ohio, Oregon, Puerto Rico, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0027-2024 (August 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0027-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.