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Use caution Medical device recall · FDA · Published October 4, 2021

Argon SuperCore Biopsy Instruments: Housing and Plunger May Detach

Argon Medical Devices recalls SuperCore biopsy instruments with serial numbers listed. Component detachment could cause injury during medical procedures.

🇺🇸 FDA recall #Z-0354-2022Medical deviceArgon Medical Devices ›
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Recalling firmArgon Medical Devices, Inc1445 Flat Creek Rd · Athens, TX 75751-5002
✎ GovInfoNow plain-language explainer

What happened, in plain English

Argon Medical Devices is recalling SuperCore biopsy instruments due to a risk that the housing or plunger may detach during use. This could lead to injury if the instrument is used improperly. Read more at govinfonow.com/recall/61720-argon-supercore-biopsy-instruments-housing-and-plunger-may-detach.

Source Summary by GovInfoNow · govinfonow.com/recall/61720-argon-supercore-biopsy-instruments-housing-and-plunger-may-detach · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0354-2022

Cite this page

“Argon SuperCore Biopsy Instruments: Housing and Plunger May Detach.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61720-argon-supercore-biopsy-instruments-housing-and-plunger-may-detach. Based on FDA recall #Z-0354-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0354-2022%22&limit=1).

Why it’s dangerous

The housing and plunger components can detach from the biopsy instruments during use. This detachment could cause injury if the instrument is not securely attached and used correctly during medical procedures.

Who’s affected

Medical professionals who own or use the recalled SuperCore biopsy instruments are affected. Those using the instruments for procedures without proper attachment are at higher risk.

How to tell if you have this one

Check for the product model numbers listed in the recall: 701114090, 701114150, 701116090, 701118060, 701118090, 701118150, 701118200, 701120090, 701120150, 701120200, 701214090, 701214150, 701216090, 701216150, 701218090, 701218150, 701218200, 701220090, 701220150, 701220200, 701114090M, 701114150M, 701116090M, SC 1409/PGI Supercore, SC 1609/PGI Supercore, SC 1806/PGI Supercore. Also check the lot numbers provided in the recall notice.

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

What to do — step by step

  1. Check Product Model

    Identify your instrument's model number and lot number to confirm if it is recalled.

  2. Contact Manufacturer

    Reach out to Argon Medical Devices for guidance on the recall process and necessary actions.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 42 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: 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: nationwideNEMissouri: 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: nationwideNMKansas: named in the noticeKSArkansas: nationwideARTennessee: 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: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

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

Named in the notice: Alabama, Alaska, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Oct 4, 202112. FDA classified it Class II: Dec 9, 202123. Published in FDA’s Enforcement Report: Dec 15, 202132021
  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-0354-2022 (October 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0354-2022 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