Argon Medical Devices, Inc
Argon Medical Devices, Inc appears in FDA public data with 48 recalls — including 8 Class I (most serious) —, 25 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2709-2026, Class I) was initiated on June 1, 2026. Its most recent 510(k) clearance was granted on February 23, 2026.
Summary
- Total Recalls
- 48 (8 Class I)
- 510(k) Clearances
- 25
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2709-2026 | Class I | Bone Marrow Tray, REF: CB0033TL; CB0355TLA | June 1, 2026 |
| Z-2707-2026 | Class I | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL | June 1, 2026 |
| Z-2705-2026 | Class I | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular | June 1, 2026 |
| Z-2706-2026 | Class I | General Biospy Tray, REF: GUTS1000 | June 1, 2026 |
| Z-2708-2026 | Class I | Arterial Line Kit 20ga x 6, REF: 400115A | June 1, 2026 |
| Z-2704-2026 | Class I | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A | June 1, 2026 |
| Z-0589-2026 | Class II | Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELIT | September 12, 2025 |
| Z-3192-2024 | Class II | BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-158 | July 2, 2024 |
| Z-2638-2024 | Class II | L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539 | June 14, 2024 |
| Z-2239-2023 | Class II | Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugula | June 8, 2023 |
| Z-0563-2022 | Class II | 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" | January 24, 2022 |
| Z-0354-2022 | Class II | SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9C | October 4, 2021 |
| Z-2501-2021 | Class II | Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a | July 8, 2021 |
| Z-1077-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biop | December 10, 2020 |
| Z-1072-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biops | December 10, 2020 |
| Z-1076-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biop | December 10, 2020 |
| Z-1074-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biop | December 10, 2020 |
| Z-1073-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biops | December 10, 2020 |
| Z-1075-2021 | Class II | Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biop | December 10, 2020 |
| Z-2806-2020 | Class II | ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - P | June 19, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm wit | February 23, 2026 |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspi | February 5, 2026 |
| K251318 | VariFuse Adjustable Infusion Catheter | January 20, 2026 |
| K253741 | VStick Vascular Access Set | December 15, 2025 |
| K242612 | Option ELITE Vena Cava Filter System (352506070E 352506100E) | September 10, 2024 |
| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C) | August 1, 2024 |
| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner Plus 18F Han | March 28, 2024 |
| K232679 | Cleaner Pro Thrombectomy System; Cleaner Pro Aspiration Catheter with Handpiece; Cleaner Pro Aspi | January 19, 2024 |
| K233432 | 10F Sheath and Dilator Set | December 8, 2023 |
| K230669 | L-Cath Single and Dual Lumen Catheters, L-Cath Midline Catheters | November 30, 2023 |
| K232443 | Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit | September 7, 2023 |
| K230631 | Kodiak Dual Port Coaxial Introducer Kit | May 22, 2023 |
| K223176 | Cleaner Plus Thrombectomy System, Cleaner Plus Aspiration Catheter, Cleaner Plus Handpiece with 6 | April 10, 2023 |
| K213232 | NovaCore Semi-Automatic Biopsy Instrument | July 1, 2022 |
| K211798 | Cleaner Plus Thrombectomy System | February 24, 2022 |
| K213638 | Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS0 | December 10, 2021 |
| K213002 | SCORPION Portal Vein Access Set | October 14, 2021 |
| K202141 | Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set | January 15, 2021 |
| K200963 | Halo Single-Loop Microsnare Kit | January 5, 2021 |
| K201489 | Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Trave | December 22, 2020 |