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Lower risk Medical device recall · FDA · Published July 2, 2024

Argon Medical BioPince Ultra Biopsy Instruments Risk: Packaging Holes Cause Infection

Argon Medical recalls BioPince Ultra Full Core Biopsy Instruments with packaging holes that may cause infections. Affected models include 360-1080-01 to 370-1580-03 and specific lot numbers. Stop using if you have these items.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3192-2024Medical deviceArgon Medical ›
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Contact the company

Recalling firmArgon Medical Devices, Inc1445 Flat Creek Rd · Athens, TX 75751-5002
✎ GovInfoNow plain-language explainer

Argon Medical is recalling BioPince Ultra Full Core Biopsy Instruments because holes in the packaging trays can compromise the sterile barrier, potentially leading to infections. This affects specific model numbers and lot dates, and users should stop using these instruments to avoid introducing microorganisms into the body. Read more at govinfonow.com/recall/54704-argon-medical-biopince-ultra-biopsy-instruments-risk-packaging-holes-cause.

Source Summary by GovInfoNow · govinfonow.com/recall/54704-argon-medical-biopince-ultra-biopsy-instruments-risk-packaging-holes-cause · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3192-2024

Cite this page

“Argon Medical BioPince Ultra Biopsy Instruments Risk: Packaging Holes Cause Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54704-argon-medical-biopince-ultra-biopsy-instruments-risk-packaging-holes-cause. Based on FDA recall #Z-3192-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3192-2024%22&limit=1).

The FDA announced on July 2, 2024, that Argon Medical Devices is recalling BioPince Ultra and Tru-Core II biopsy instruments due to holes in packaging trays that compromise sterility. The agency stated the defect may lead to cross-contamination or infection.

How to tell if you have it

  • Brand: Argon Medical
  • Product: BioPince Ultra Full Core Biopsy Instrument, REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 360-1580-03, 360-2080-01, 360-2080-02, 360-2080-03, 370-1080-01, 370-1080-02, 370-1080-03, 370-1580-01, 370-1580-02, 370-1580-03
  • Product: Tru-Core II Biopsy Instrument, REF: 763114100x, 763116100X, 763116160X, 763118100X, 763118200X, 763120100X, 763120160X, 763418200X, 763418250X, 763114200X
  • Units affected: 95,430

The hazard

Holes in the biopsy instrument packaging trays compromise the sterile barrier. According to the FDA, this defect may lead to cross-contamination or the introduction of micro-organisms into the access site, which could result in an infectious process, bacteremia, or sepsis.

Context

GovInfoNow's records show Argon Medical Devices has issued 15 other recalls since October 16, 2018. Recent brand recalls include the June 15, 2026 L-Cath Midline Catheter Recall for leaking hubs and the June 1, 2026 General Biospy Tray Recall for sterility risks. Other recent recalls of similar products include the Boston Scientific Radial Jaw 4 Biopsy Forceps packaging risk (June 30, 2026) and the Medline Olympus Biopsy Kits recall (February 16, 2026).

How to tell if you have this one

Check for model numbers starting with 360-1080-01 to 370-1580-03 or specific lot numbers listed in the recall notice. The instruments were sold with expiration dates ranging from March 2027 to May 2029.

  • Brand
    Argon Medical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    If you have the recalled BioPince Ultra Full Core Biopsy Instruments, stop using them immediately to prevent potential infections.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 47 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of AZ, FL, OH, NY, MO, CO, IL, NC, CA, AK, PA, MN, ND, TX, SC, AR, WI, OK, TN, KS, UT, NJ, VA, MA, KY, IN, AL, DE, MT, NE, WV, NV, HI, OR, WA, NH, LA, CT, MI, GA, MD, ID, MS,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, 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, Rhode Island, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Jul 2, 202412. FDA classified it Class II: Sep 20, 202423. Published in FDA’s Enforcement Report: Oct 2, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-3192-2024 (July 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3192-2024 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA