Facility
ARGON MEDICAL DEVICES INC.
23 recall(s) on record — most severe on record: Class I.
Activity by year
- Recalls (23)
- Inspections (2)
Devices registered here (1)
- Injector And Syringe, AngiographicProduct code DXT (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1650
Recalls & enforcement
20262 records
- Class IIOngoing2026-06-15Catheters, 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, cath…
- Class IOngoing2026-06-01Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
20251 record
- Class IIOngoing2025-09-12Due 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
20242 records
- Class IIOngoing2024-07-02Holes 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.
- Class IIOngoing2024-06-14Peripherally 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.
20231 record
- Class IIOngoing2023-06-08There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
20221 record
- Class IIOngoing2022-01-24Guidewire 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.
20212 records
- Class IIOngoing2021-10-04Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.
- Class IIOngoing2021-07-08As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
20204 records
- Class IITerminated2020-12-10Due 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 …
- Class IITerminated2020-06-19Sterile introducer sheath set manufactured under one lot with different expiration dates.
- Class IITerminated2020-04-26Tungsten coils of the guidewire included in the introducer kit were detaching.
- Class IITerminated2020-04-08Arterial 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…
20192 records
- Class ITerminated2019-12-04The stiffness of the soft end of the guidewire caused tissue perforation.
- Class IITerminated2019-12-02Incorrect product labeling.
20181 record
- Class IITerminated2018-10-16The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
20172 records
- Class IITerminated2017-05-11Argon 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.
- Class IITerminated2017-01-18The 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.
20162 records
- Class IITerminated2016-09-08The 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
- Class IITerminated2016-02-17The 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.
20151 record
- Class IITerminated2015-06-18Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.
20141 record
- Class IITerminated2014-06-05UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
20121 record
- Class IITerminated2012-05-04Some of the kits may exhibit a potential defect with the pouch seal. The pouch issue may compromise the sterile barrier.
FDA inspections (2)
- NAI2021-11-04No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
- VAI2016-05-27Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “ARGON MEDICAL DEVICES INC. (FEI 1625425) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1625425-argon-medical-devices-inc/
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