Athens, TX, United States
Argon Medical Devices, Inc recalls
16 recalls recorded since 2018, most recently on 15 June 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.
Recalls16
Ongoing (FDA)9
Terminated or completed7
Class I (FDA)2
Ongoing Class II Medical devices
- Recall started
- 15 June 2026
- Reason
- Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
- Distribution
- US: AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OR, TN, TX, UT, VA, WA. OUS: MYS, CAN, SAU
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2804-2026, Z-2803-2026
- L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
- L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 38
Ongoing Class I Medical devices
- Recall started
- 1 June 2026
- Reason
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Distribution
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2706-2026, Z-2708-2026, Z-2704-2026, Z-2705-2026, Z-2707-2026, Z-2709-2026
- General Biospy Tray, REF: GUTS1000
- Arterial Line Kit 20ga x 6, REF: 400115A
- Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
- One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
- T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
- Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Ongoing Class II Medical devices
- Recall started
- 12 September 2025
- Reason
- Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
- Distribution
- U.S. (nationwide) distribution to states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S. (international) to countries of: China, Panama and Trinidad and
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0589-2026
- Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior
Ongoing Class II Medical devices
- Recall started
- 2 July 2024
- Reason
- Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.
- 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, IA, RI, NM, VT and the countries of ITA, TUN, ROU, LTU, BEL,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3192-2024
- BioPince Ultra Full Core Biopsy Instrument: REF: 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, 370-1580-0
Ongoing Class II Medical devices
- Recall started
- 14 June 2024
- Reason
- Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but package contains incorrect 26G/1.9Fr x 50cm PICC, which could lead to procedural delay.
- Distribution
- US distribution to the states of: TX, WA, CA, IL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2638-2024
- L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Ongoing Class II Medical devices
- Recall started
- 8 June 2023
- Reason
- There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
- Distribution
- US Nationwide distribution in the state of TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2239-2023
- Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
Ongoing Class II Medical devices
- Recall started
- 24 January 2022
- Reason
- Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.
- Distribution
- US Nationwide distribution in the states of AL, CA, DE, IL, IN, LA, MT, NV, OH, TX, VA, TN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0563-2022
- 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Ongoing Class II Medical devices
- Recall started
- 4 October 2021
- Reason
- Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
- 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 WV. The countries of ALB, ARE, ARG, AUS, AUT, BEL, BGD, BRA,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0354-2022
- SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIO
Ongoing Class II Medical devices
- Recall started
- 8 July 2021
- Reason
- As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
- Distribution
- U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2501-2021
- Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Terminated Class II Medical devices
- Recall started
- 10 December 2020
- Terminated
- 31 January 2023
- Reason
- 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.
- 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, T
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1076-2021, Z-1075-2021, Z-1073-2021, Z-1077-2021, Z-1074-2021, Z-1072-2021
- 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
- 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,
- 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,
- 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,
- 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,
- 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,
Terminated Class II Medical devices
- Recall started
- 19 June 2020
- Terminated
- 12 April 2023
- Reason
- Sterile introducer sheath set manufactured under one lot with different expiration dates.
- Distribution
- US Nationwide distribution including in the state of MS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2806-2020
- ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits built to user specifica
Terminated Class II Medical devices
- Recall started
- 26 April 2020
- Terminated
- 16 December 2022
- Reason
- Tungsten coils of the guidewire included in the introducer kit were detaching.
- Distribution
- International distribution to the countries of China, Taiwan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2109-2020
- Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System with radiopaque marker is intended for fine needle puncture and tissue di
Terminated Class II Medical devices
- Recall started
- 8 April 2020
- Terminated
- 14 December 2022
- Reason
- Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
- Distribution
- US Nationwide distribution including the states of CA, IL, ND, SC, TX, VA. OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1938-2020, Z-1937-2020, Z-1936-2020
- PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use in arterial and venous procedures requiring percutaneous introduction
- Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or fr
- Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when in instances where continuous invasive blood pressure readings and/or f
Terminated Class I Medical devices
- Recall started
- 4 December 2019
- Terminated
- 1 April 2024
- Reason
- The stiffness of the soft end of the guidewire caused tissue perforation.
- Distribution
- No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1792-2020, Z-1791-2020
- 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
- 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Terminated Class II Medical devices
- Recall started
- 2 December 2019
- Terminated
- 9 November 2022
- Reason
- Incorrect product labeling.
- Distribution
- Worldwide distribution - US Nationwide including in the states of TX, IL, FL, KS, MD, CA, WA, NY, WI, PA and the countries of United Arab Emirates (Dubai), Spain, Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2427-2020
- BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automatic BioPince Full Core Biopsy Instrument is used to obtain multiple core
Terminated Class II Medical devices
- Recall started
- 16 October 2018
- Terminated
- 15 June 2021
- Reason
- The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
- Distribution
- Distribution was nationwide. There was military/government distribution. Foreign distribution was made to Canada, Australia, the Netherlands, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0293-2020, Z-0291-2020, Z-0288-2020, Z-0289-2020, Z-0296-2020, Z-0294-2020, Z-0295-2020, Z-0292-2020, Z-0290-2020
- (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Sterile, Rx; (2) Argon Medical Devices Vascuclamp, Radiopaque Vascular C
- Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter t
- Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed in a box. The firm name on the label is Argon Medical Devices, Inc., At
- Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.
- and 1 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.