Argon Medical Devices, Inc

Complete recall history across all FDA and CPSC categories — 42 total recalls

Argon Medical Devices, Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (42)

FDA medical device enforcement actions by Argon Medical Devices, Inc

Date Product Reason Class
Sep 12, 2025 Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 0088633321... Due to complaints of increased resistance when advancing the dilator within t... Class II
Jul 2, 2024 BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-0... Holes have been identified in biopsy instrument packaging trays compromising ... Class II
Jun 14, 2024 L-CATH PICC S/L Peripherally Inserted Central Catheter, 26Ga (1.9F) 0.60mm x ... Peripherally Inserted Central Catheter (PICC) is labeled 26G/1.9Fr x 30cm but... Class II
Jun 8, 2023 Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Fil... There is the potential that the vena Cava Filter may not perform as intended ... Class II
Jan 24, 2022 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6" Guidewire included with two lots of Arterial Line Kits would not fit through ... Class II
Oct 4, 2021 SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE... Due to component (housing and plunger) detaching from the semi-automatic biop... Class II
Jul 8, 2021 Scorpion Portal Vein Access Set - Product Usage: used to gain access to the h... As a result of design changes, sheaths have exhibited cracking/breaking at th... Class II
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18S,... Due to a manufacturing error their is a potential that the sheath within the ... Class II
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19N,... Due to a manufacturing error their is a potential that the sheath within the ... Class II
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18N,... Due to a manufacturing error their is a potential that the sheath within the ... Class II
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19, ... Due to a manufacturing error their is a potential that the sheath within the ... Class II
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 19S,... Due to a manufacturing error their is a potential that the sheath within the ... Class II
Dec 10, 2020 Argon Medical Devices TLAB, Transjugular Liver Biopsy System, REF: TL - 18C,... Due to a manufacturing error their is a potential that the sheath within the ... Class II
Jun 19, 2020 ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. ... Sterile introducer sheath set manufactured under one lot with different expir... Class II
Apr 26, 2020 Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 65550... Tungsten coils of the guidewire included in the introducer kit were detaching. Class II
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498411B, Rx Only, Sterile EO, UDI: 008863... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-sil... Class II
Apr 8, 2020 Arterial Line Kit 20ga X 3", Model 498106, Rx Only, Sterile EO, UDI: 0088633... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-sil... Class II
Apr 8, 2020 PAC Tray/5 Catheter Introducer Tray 8F, Model 497424, Rx Only, STERILE EO, UD... Arterial Line Kits include thicker curved reverse-cutting needle with a 0-sil... Class II
Dec 4, 2019 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 1141... The stiffness of the soft end of the guidewire caused tissue perforation. Class I
Dec 4, 2019 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114... The stiffness of the soft end of the guidewire caused tissue perforation. Class I
Dec 2, 2019 BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial... Incorrect product labeling. Class II
Oct 16, 2018 (1) Argon Medical Devices Stopcocks, Clear 4-Way Stopcock w/Male Luer Lock, R... The seal formed on the edge of the pouch may be incomplete, which could resul... Class II
Oct 16, 2018 Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/b... The seal formed on the edge of the pouch may be incomplete, which could resul... Class II
Oct 16, 2018 Argon Medical Devices Septishield II, 80 cm, REF 497302, 25/box, Sterile, Rx.... The seal formed on the edge of the pouch may be incomplete, which could resul... Class II
Oct 16, 2018 Argon Medical Devices Hemostasis Valve, 7F-9F, REF 049297, Single Use Only, N... The seal formed on the edge of the pouch may be incomplete, which could resul... Class II
Oct 16, 2018 Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm n... The seal formed on the edge of the pouch may be incomplete, which could resul... Class II
Oct 16, 2018 Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-steri... The seal formed on the edge of the pouch may be incomplete, which could resul... Class II
Oct 16, 2018 (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Conver... The seal formed on the edge of the pouch may be incomplete, which could resul... Class II
Oct 16, 2018 Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Sto... The seal formed on the edge of the pouch may be incomplete, which could resul... Class II
Oct 16, 2018 (1) Argon Medical Devices Vascuclamp, Radiopaque Vascular Clamp, Small Straig... The seal formed on the edge of the pouch may be incomplete, which could resul... Class II
May 11, 2017 Clear Flashback Needle 7cm x 18G AMC/4; Clear Flashback Needle 2.5 cm x 21G A... Argon Medical has received a complaint from one of their distributors of a po... Class II
Jan 18, 2017 BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for... The recalling firm received a complaint from one of their customers of a pote... Class II
Jan 18, 2017 T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEED... The recalling firm received a complaint from one of their customers of a pote... Class II
Jan 18, 2017 HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or... The recalling firm received a complaint from one of their customers of a pote... Class II
Sep 8, 2016 MicroStic Plus w/SS Wire 5F and MicroStic Plus w/NiTi Wire & Echo Needle 4F. ... The supplier initiated a recall because affected lots of the micro-introducer... Class II
Feb 17, 2016 ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and... The incorrect sheath was assembled to the device so that the size 7 products ... Class II
Jun 18, 2015 Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Ma... Potential defect in the forming of the primary package of the blister that ma... Class II
Jun 18, 2015 T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lo... Potential defect in the forming of the primary package of the blister that ma... Class II
Jun 5, 2014 UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 320... UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arte... Class II
Jun 5, 2014 UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 3... UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arte... Class II
Jun 5, 2014 UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524... UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arte... Class II
May 4, 2012 Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek ba... Some of the kits may exhibit a potential defect with the pouch seal. The pou... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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