The Recall Desk
HighFDA (Devices)·Z-2803-2026·Announced 2026-08-05

Peripherally Inserted Central Catheters Recalled Due to Hub Leaking and Cracking Risk

Argon Medical Devices is recalling certain L-Cath PICC catheters because the hub may leak or crack, potentially causing blood loss, infection, or therapy interruption.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with potential for blood loss and bloodstream infection. No injuries or deaths are reported in the notice, so it meets the High rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Argon Medical Devices, Inc. is recalling certain L-Cath PICC S/L Peripherally Inserted Central Catheters. The affected devices are identified by REF numbers 384539, 384464, 384516, and 384463, with specific lot numbers and expiration dates listed in the FDA recall notice. The FDA has classified this as a Class II recall.

The catheters may leak and/or crack at the hub. According to the notice, this could lead to catheter replacement, inability to flush or aspirate the catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, and bloodstream infection.

The affected devices were distributed in the United States and internationally. The recall notice does not state that any injuries or deaths have occurred. The notice does not provide specific consumer instructions; patients who have this catheter should discuss the recall with their healthcare provider.

The recalled product

Product
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
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Peripherally Inserted Central Catheter (PICC)
Hazard
Affected units
6,928

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 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)

Distribution

Distributed in 28 states:

Part of a larger recall action

This product is one of 2 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Argon Medical Devices, Inc

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Same hazard · device leak

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