Use caution Medical device recall · FDA · Published December 10, 2020

Argon Medical Devices TLAB System Recall: Sheath Separation Risk

Argon Medical Devices recalls TLAB liver biopsy kits with potential sheath separation during use, risking surgical intervention. Affected kits have specific lot numbers.

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

🇺🇸 FDA recall #Z-1076-2021Medical device Argon Medical Devices ›

Use caution until it’s fixed

Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during use if the tip is flexed or experiences bending stresses. This could result in need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.

Take action

Contact the company

Recalling firmArgon Medical Devices, Inc1445 Flat Creek Rd · Athens, TX 75751-5002

✎ GovInfoNow plain-language explainer

Argon Medical Devices is recalling certain liver biopsy kits because a manufacturing error may cause the sheath to separate during use. This could require surgery to prevent permanent damage to the liver or other body structures. Read more at govinfonow.com/recall/63683-argon-medical-devices-tlab-system-recall-sheath-separation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63683-argon-medical-devices-tlab-system-recall-sheath-separation-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1076-2021

Cite this page

“Argon Medical Devices TLAB System Recall: Sheath Separation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63683-argon-medical-devices-tlab-system-recall-sheath-separation-risk. Based on FDA recall #Z-1076-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1076-2021%22&limit=1).

The FDA announced on Dec. 10, 2020, that Argon Medical Devices, Inc. is recalling its TLAB Transjugular Liver Biopsy Systems due to a potential sheath separation during use. The agency classified the recall as Class II.

How to tell if you have it

Brand: Argon Medical Devices
Product: TLAB, Transjugular Liver Biopsy System
REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO
Lot Numbers: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182
Units: 1759

The hazard

According to the FDA, a manufacturing error may cause the sheath within the biopsy kit to separate if the tip is flexed or experiences bending stresses. This could result in the need for surgical intervention to preclude or reverse permanent damage to a body structure or permanent impairment of a body function.

Context

GovInfoNow's records show Argon Medical Devices, Inc. has 15 other recalls on record since Oct. 16, 2018. Other recent recalls of similar products include Argon Medical L-Cath PICC Catheters Recall (June 15, 2026), Argon Medical Devices General Biospy Tray Recall (June 1, 2026), and Argon Medical Devices Option ELITE Vena Cava Filter System Recall (Sept. 12, 2025). Other recent recalls of similar products include Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026), Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (July 9, 2026), and Medline Medical Kits Recall (July 8, 2026).

How to tell if you have this one

Check for the product name 'Argon Medical Devices TLAB, Transjugular Liver Biopsy System' with specific lot numbers: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182.

Brand
Argon Medical Devices
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong, Thailand, Portugal, Taiwan, Austria, Brazil, Netherlands, Italy, Germany, Colombia, Singapore, Canada, View Nam, Slovakia, Spain

Recall number	Product, codes & lots	Quantity
Z-1072-2021	Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/6f Straight Catheter, Sterile EO,; Lot Number: 1419196, 1460291, 1469844, 1502325	483 units
Z-1073-2021	Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Stiffener, Tissue Removal Swabs, 5F Straight Catheter, 5F Curved Catheter, Sterile EO,; Lot Number: 1428364, 1451428, 1486448	863 unit
Z-1074-2021	Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,; Lot Number: 1439836, 1451430, 1486441	187 units
Z-1075-2021	Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, Sterile EO,; Lot Number: 1439835,1451429, 1486445	247 units
Z-1076-2021	Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, 1/5f straight catheter, 1/5F Curved Catheter Sterile EO,; Lot Number: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182	1759 units
Z-1077-2021	Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal Stiffener, 4/Tissue Removal Swabs, Sterile EO,; Lot Number: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182	583 units

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for the lot numbers listed: 1394204, 1424962, 1464709, 1473181, 1477229, 1481735, 1495182.

Where it went and when

Where it was distributed

Distributed in 44 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US: AL AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA,, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX,, UT, VA, WA, WI, WV, WY OUS: Switzerland, Saudi Arabia, Hong Kong,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

Dec 10, 2020Firm started the recall
Feb 5, 2021FDA classified it Class II
Feb 17, 2021Published in FDA’s Enforcement Report
Jan 31, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63683-argon-medical-devices-tlab-system-recall-sheath-separation-risk">Argon Medical Devices TLAB System Recall: Sheath Separation Risk (GovInfoNow)</a>

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-1076-2021 (December 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1076-2021 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.