Bard MARQUEE Disposable Core Biopsy Instruments Recall: Penetration Depth Switch Detaches
Bard recalls disposable core biopsy instruments with a penetration depth switch that can detach during use, posing a risk of injury. Affected models include MQ1210 to MQK2016 with specific UDI codes and lot numbers.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Bard is recalling disposable core biopsy instruments that have a penetration depth switch which can detach during use. This could lead to injury if the detached switch causes the needle to move unexpectedly. Read more at govinfonow.com/recall/63425-bard-marquee-disposable-core-biopsy-instruments-recall-penetration-depth-switch.
Source Summary by GovInfoNow · govinfonow.com/recall/63425-bard-marquee-disposable-core-biopsy-instruments-recall-penetration-depth-switch · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1289-2021
Cite this page
“Bard MARQUEE Disposable Core Biopsy Instruments Recall: Penetration Depth Switch Detaches.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63425-bard-marquee-disposable-core-biopsy-instruments-recall-penetration-depth-switch. Based on FDA recall #Z-1289-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1289-2021%22&limit=1).
Why it’s dangerous
The penetration depth switch, which selects how deep the biopsy needle penetrates soft tissue, can become detached during use. This detachment might cause the needle to move unexpectedly, potentially leading to injury.
Who’s affected
Medical professionals who use these instruments for soft tissue biopsies are most at risk. Patients using these instruments for procedures are also affected.
How to tell if you have this one
Check for the model numbers listed (MQ1210 to MQK2016) or the UDI codes and lot numbers provided in the recall notice. The instruments are used for soft tissue biopsies and come with specific sizes and weights.
- Brand
Bard- Category
Medical device
What to do — step by step
Check for Detachment
Inspect the penetration depth switch for detachment before use. If detached, stop using the instrument immediately.
Contact Bard
Reach out to Bard Peripheral Vascular Inc for specific guidance on affected models and remedies.
Where it went and when
Where it was distributed
Distributed in 50 states and D.C. and Puerto Rico, and outside the U.S.
FDA distribution: “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.:…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1289-2021 (January 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1289-2021 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.