Argon Medical Devices TLAB — Class II medical device recall Z-1075-2021
Terminated recall by Argon Medical Devices, Inc, reported 2021-02-17, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Due to a manufacturing error their is a potential that the sheath within the biopsy kit can separate during us
| Recall number | Z-1075-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2020-12-10 |
| Classified | 2021-02-05 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2023-01-31 |
| Distributed | 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 |
| Countries outside the US | AT, BR, CA, CH, CO, DE, ES, HK, IT, NL, PT, SA, SG, SK, TH, TW |
| Quantity | 247 units |
| Lot numbers | 1439835, 1451429, 1486445 |
| Model numbers | 1/19GA, 19S |
Product
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,
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1075-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.