FDA Reports Class II Recall of Argon Medical Devices Catheters
The FDA published an enforcement report for a recall of 20 catheters due to potential cracking and leaking at the hub.
2 reports on this incident · first at Aug 20, 2026, 9:09 a.m. ET
Earlier reports
Aug 20, 2026, 9:09 a.m. ETFirst report
FDA Reports Class II Recall of Argon Medical Devices Catheters
On August 5, 2026, FDA records reported an ongoing, developing recall initiated on June 15, 2026, by Argon Medical Devices, Inc., located in Athens. The recall applies to 20 units of the product L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620.
According to FDA recall record Z-2804-2026, the impacted product carries the identifying code REF/UDI-DI/Lot(Expiration): 384620/00886333210008/11490543(7/28/2026). The catheters are indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling. The agency report states that the devices 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.
The agency classified the action under Class II. The FDA defines Class II as its middle category, used where the product may cause temporary or medically reversible harm, and where the chance of serious harm is remote. The affected units were distributed in the US to AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OR, TN, TX, UT, VA, WA, as well as internationally to CAN, MYS, and SAU. FDA database records record no other enforcement action by this firm, which says nothing about fault in the present recall.
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- Version 120 Aug 2026, 13:09current
First published.
- Version 120 Aug 2026, 13:24
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- Version 120 Aug 2026, 13:10current
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