PlainRecalls

Argon Medical Devices, Inc

Compiled from official public sources by the editorial team.

42 recalls on record · Latest: Dec 3, 2025

Argon Medical Devices, Inc Recall Insight

Argon Medical Devices, Inc appears on 42 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.041% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 3, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 42 entries, severity tagging shows 2 critical, 40 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 42 of 42 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (42). The date window on this page runs from Jul 18, 2012 to Dec 3, 2025.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Dec 3, 2025

Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recur…

FDA Devices Moderate Oct 2, 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-…

FDA Devices Moderate Aug 21, 2024

L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x 30cm, REF: 384539

FDA Devices Moderate Aug 2, 2023

Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797

FDA Devices Moderate Feb 16, 2022

1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"

FDA Devices Moderate Dec 15, 2021

SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM;…

FDA Devices Moderate Sep 29, 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 Needl…

FDA Devices Moderate Feb 17, 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 …

FDA Devices Moderate Feb 17, 2021

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S, 1/19 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal …

FDA Devices Moderate Feb 17, 2021

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, 1/19 GA Flexcore Biopsy Needle, 7F Introducer Sheath W/Curved Metal Sti…

FDA Devices Moderate Feb 17, 2021

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal …

FDA Devices Moderate Feb 17, 2021

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N, 1/19 GA Flexcore Biopsy Needle, 1.7F Introducer Sheath W/Curved Metal …

FDA Devices Moderate Feb 17, 2021

Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S, 1/18 GA Flexcore Biopsy Needle, 1/7F Introducer Sheath W/Curved Metal S…

FDA Devices Moderate Aug 26, 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…

FDA Devices Moderate Jul 1, 2020

BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle MCXS1615BP. QTY.: 5/CS - Product Usage: The disposable, automati…

FDA Devices Moderate Jun 3, 2020

Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079 - Product Usage: The Skater Introducer System wi…

FDA Devices Moderate May 20, 2020

PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UDI: 00886333214440 - Product Usage: The introducers are indicated for use…

FDA Devices Moderate May 20, 2020

Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 00886333215577 - Product Usage: Arterial Catheters are indicated for use when i…

FDA Devices Moderate May 20, 2020

Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 00886333215652 - Product Usage: Arterial Catheters are indicated for use when …

FDA Devices Critical May 13, 2020

0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO

FDA Devices Critical May 13, 2020

0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO

FDA Devices Moderate Nov 13, 2019

(1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straight, REF 046-1-200, 2 clamps/package, 5 packages/box, 10 boxes/case, Ster…

FDA Devices Moderate Nov 13, 2019

Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label …

FDA Devices Moderate Nov 13, 2019

(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 …

FDA Devices Moderate Nov 13, 2019

Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, …

FDA Devices Moderate Nov 13, 2019

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 Devices Moderate Nov 13, 2019

Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, Non-Sterile-Further Processing Required, 250 valves/bag which is placed i…

FDA Devices Moderate Nov 13, 2019

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.

FDA Devices Moderate Nov 13, 2019

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, I…

FDA Devices Moderate Nov 13, 2019

(1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, REF 041210002A, 25/box, Sterile, Rx; (2) Argon Medical Devices Stopcoc…

FDA Devices Moderate Jun 14, 2017

Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G AMC/4; Winged Arterial Needle 7cm x 18G AMC/4; Clear Flashback Needle 7 c…

FDA Devices Moderate Feb 22, 2017

HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens

FDA Devices Moderate Feb 22, 2017

T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or…

FDA Devices Moderate Feb 22, 2017

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 Devices Moderate Oct 12, 2016

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 skin into …

FDA Devices Moderate Mar 9, 2016

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 IS-7F11. I…

FDA Devices Moderate Jul 29, 2015

T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bo…

FDA Devices Moderate Jul 29, 2015

Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow A…

FDA Devices Moderate Oct 1, 2014

UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32…

FDA Devices Moderate Oct 1, 2014

UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Me…

FDA Devices Moderate Oct 1, 2014

UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medic…

FDA Devices Moderate Jul 18, 2012

Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte.…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.