← FDA ENFORCEMENT
Z-2803-2026Class II

Argon Medical Devices, Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Argon Medical Devices, Inc
Product type
Device
Status
Ongoing
Report date
2026-08-05
Distribution
US: 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. OUS: MYS, CAN, SAU
Firm state
TX
Product quantity
6928
Initiated by
Voluntary: Firm initiated
Reason for recall

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 lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.

Product description

L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463

Code / lot info

REF/UDI-DI/Lot(Expiration): 384539/00886333209934/11488167(7/14/2026), 11488168(7/17/2026), 11494535E(8/1/2026), 11507766(11/13/2026), 11550780(12/12/2026), 11551487(12/15/2026), 11551488(12/15/2026); 384464/00886333209835/11490593(7/28/2026), 11494886(8/28/2026)11501150(10/6/2026); 384516/00886333209910/11500410(8/14/2026), 11501856(8/14/2026), 11504222(9/9/2026), 11506952(9/9/2026), 11523868(9/18/2026), 11551789(9/18/2026), 11553909(11/13/2026), 11559226(11/20/2026); 384463/00886333209828/11490797(8/1/2026), 11490959(8/11/2026)

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →