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Argon Medical Devices Recalls
50 recalls on record · July 18, 2012 to August 5, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 5, 2026Medical DevicesFDA
Argon Medical Devices, Inc recalls L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
Hazard: 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.
August 5, 2026Medical DevicesFDA
Argon Medical Devices, Inc recalls L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60c
Hazard: 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.
July 22, 2026Medical DevicesFDA
Argon Medical Devices, Inc recalls Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
July 22, 2026Medical DevicesFDA
Argon Medical Devices, Inc recalls Arterial Line Kit 20ga x 6, REF: 400115A
Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
July 22, 2026Medical DevicesFDA
Argon Medical Devices, Inc recalls T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
July 22, 2026Medical DevicesFDA
Argon Medical Devices, Inc recalls General Biospy Tray, REF: GUTS1000
Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
July 22, 2026Medical DevicesFDA
Argon Medical Devices, Inc recalls One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
July 22, 2026Medical DevicesFDA
Argon Medical Devices, Inc recalls Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
Hazard: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
December 3, 2025Medical DevicesFDA
Argon Medical Devices, Inc recalls Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicate
Hazard: 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
October 2, 2024Medical DevicesFDA
Argon Medical Devices, Inc recalls BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-1580-01, 360-1580-02, 3
Hazard: 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.
August 21, 2024Medical DevicesFDA
Argon Medical Devices, Inc recalls L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
Hazard: 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.
August 2, 2023Medical DevicesFDA
Argon Medical Devices, Inc recalls Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Deliver
Hazard: There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
February 16, 2022Medical DevicesFDA
Argon Medical Devices, Inc recalls 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
Hazard: 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.
December 15, 2021Medical DevicesFDA
Argon Medical Devices, Inc recalls SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERC
Hazard: Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
September 29, 2021Medical DevicesFDA
Argon Medical Devices, Inc recalls Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool
Hazard: As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
February 17, 2021Medical DevicesFDA
Argon Medical Devices, Inc recalls Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Intr
Hazard: 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.
February 17, 2021Medical DevicesFDA
Argon Medical Devices, Inc recalls Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Intr
Hazard: 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.
February 17, 2021Medical DevicesFDA
Argon Medical Devices, Inc recalls Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Intr
Hazard: 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.
February 17, 2021Medical DevicesFDA
Argon Medical Devices, Inc recalls Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Intr
Hazard: 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.
February 17, 2021Medical DevicesFDA
Argon Medical Devices, Inc recalls Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introdu
Hazard: 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.
February 17, 2021Medical DevicesFDA
Argon Medical Devices, Inc recalls Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Intro
Hazard: 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.
August 26, 2020Medical DevicesFDA
Argon Medical Devices, Inc recalls ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introd
Hazard: Sterile introducer sheath set manufactured under one lot with different expiration dates.
July 1, 2020Medical DevicesFDA
Argon Medical Devices, Inc recalls BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Us
Hazard: Incorrect product labeling.
June 3, 2020Medical DevicesFDA
Argon Medical Devices, Inc recalls Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: Th
Hazard: Tungsten coils of the guidewire included in the introducer kit were detaching.
May 20, 2020Medical DevicesFDA
Argon Medical Devices, Inc recalls PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The intr
Hazard: 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.
May 20, 2020Medical DevicesFDA
Argon Medical Devices, Inc recalls Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters
Hazard: 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.
May 20, 2020Medical DevicesFDA
Argon Medical Devices, Inc recalls Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheter
Hazard: 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.
May 13, 2020Medical DevicesFDA
Argon Medical Devices, Inc recalls 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE E
Hazard: The stiffness of the soft end of the guidewire caused tissue perforation.
May 13, 2020Medical DevicesFDA
Argon Medical Devices, Inc recalls 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE E
Hazard: The stiffness of the soft end of the guidewire caused tissue perforation.
November 13, 2019Medical DevicesFDA
Argon Medical Devices, Inc recalls Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices,
Hazard: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.