Argon Medical Devices recalls
Argon Medical Devices appears in 50 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-05.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 50 |
|---|---|
| Published | 2012-07-18 to 2026-08-05 |
| By agency | FDA Device (50) |
| By classification | Class II (42), Class I (8) |
| By status | terminated (35), ongoing (15) |
| Distribution named in notices | 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, US, UT, VA, WA, WI, WV, WY |
Recalls
- L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA Device · Class II · 2026-08-05 · Argon Medical Devices
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 le… - L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
FDA Device · Class II · 2026-08-05 · Argon Medical Devices
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 le… - General Biospy Tray, REF: GUTS1000
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
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. - Arterial Line Kit 20ga x 6, REF: 400115A
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
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. - One-Piece Introducer Tray, REF: 497455, 497434 cardiovascular
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
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. - T-Lok Bone Marrow Tray, REF: BMT1104STL
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
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. - Bone Marrow Tray, REF: CB0033TL
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
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. - Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A, 008566A
FDA Device · Class I · 2026-07-22 · Argon Medical Devices
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. - Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of…
FDA Device · Class II · 2025-12-03 · Argon Medical Devices
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 appl… - 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, 360-208…
FDA Device · Class II · 2024-10-02 · Argon Medical Devices
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 a… - L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539
FDA Device · Class II · 2024-08-21 · Argon Medical Devices
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. - Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly…
FDA Device · Class II · 2023-08-02 · Argon Medical Devices
Reason: There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism. - 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
FDA Device · Class II · 2022-02-16 · Argon Medical Devices
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. - SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM
FDA Device · Class II · 2021-12-15 · Argon Medical Devices
Reason: Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. - 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…
FDA Device · Class II · 2021-09-29 · Argon Medical Devices
Reason: As a result of design changes, sheaths have exhibited cracking/breaking at the tips. - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices
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 t… - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices
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 t… - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices
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 t… - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices
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 t… - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curve…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices
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 t… - Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved M…
FDA Device · Class II · 2021-02-17 · Argon Medical Devices
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 t… - ClosureFast Micro Introducer Sheath Set, REF MIS-7F11
FDA Device · Class II · 2020-08-26 · Argon Medical Devices
Reason: Sterile introducer sheath set manufactured under one lot with different expiration dates. - BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable,…
FDA Device · Class II · 2020-07-01 · Argon Medical Devices
Reason: Incorrect product labeling. - Skater Introducer Set 6F x 18cm
FDA Device · Class II · 2020-06-03 · Argon Medical Devices
Reason: Tungsten coils of the guidewire included in the introducer kit were detaching. - Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for…
FDA Device · Class II · 2020-05-20 · Argon Medical Devices
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 nee… - Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for u…
FDA Device · Class II · 2020-05-20 · Argon Medical Devices
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 nee… - PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicat…
FDA Device · Class II · 2020-05-20 · Argon Medical Devices
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 nee… - 0.035"(.89mm)x150 cm guidewire
FDA Device · Class I · 2020-05-13 · Argon Medical Devices
Reason: The stiffness of the soft end of the guidewire caused tissue perforation. - 0.035"(.89mm)x80 cm guidewire
FDA Device · Class I · 2020-05-13 · Argon Medical Devices
Reason: The stiffness of the soft end of the guidewire caused tissue perforation. - (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. - (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. - (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. - Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which i…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. - Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. - Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical D…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. - Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on t…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. - Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. - Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., At…
FDA Device · Class II · 2019-11-13 · Argon Medical Devices
Reason: The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product. - Clear Flashback Needle 7cm x 18G AMC/4
FDA Device · Class II · 2017-06-14 · Argon Medical Devices
Reason: Argon Medical has received a complaint from one of their distributors of a potential packaging defect. The product is sealed in a pouch and the defect if present shows as a potential void or unsealed edge of the pouch. - T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN
FDA Device · Class II · 2017-02-22 · Argon Medical Devices
Reason: The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. - BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
FDA Device · Class II · 2017-02-22 · Argon Medical Devices
Reason: The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. - HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
FDA Device · Class II · 2017-02-22 · Argon Medical Devices
Reason: The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. - MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. A sheath used to facilitate placing a catheter through the ski…
FDA Device · Class II · 2016-10-12 · Argon Medical Devices
Reason: The supplier initiated a recall because affected lots of the micro-introducer have an outer diameter of the dilator hub that is slightly smaller than is capable of securing the dilator to the sheath - ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF I…
FDA Device · Class II · 2016-03-09 · Argon Medical Devices
Reason: The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths. - Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501
FDA Device · Class II · 2015-07-29 · Argon Medical Devices
Reason: Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. - T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL
FDA Device · Class II · 2015-07-29 · Argon Medical Devices
Reason: Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. - UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm)
FDA Device · Class II · 2014-10-01 · Argon Medical Devices
Reason: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. - UltraStream Peel Away Kit
FDA Device · Class II · 2014-10-01 · Argon Medical Devices
Reason: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. - UltraStream Chronic Hemodialysis Catheter Standard Kit
FDA Device · Class II · 2014-10-01 · Argon Medical Devices
Reason: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. - Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Sing…
FDA Device · Class II · 2012-07-18 · Argon Medical Devices
Reason: Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.