Argon Medical Devices Recalls L-Cath PICC Catheters

Source: FDA · United States

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Argon Medical Devices, Inc. is recalling 6,928 units of L-Cath PICC catheters due to potential leaking or cracking at the hub.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 13, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.

What Happened

Argon Medical Devices, Inc. initiated a voluntary recall of certain L-Cath PICC catheters after reports that the devices may experience leaking and/or cracking at the hub. This could result in catheter replacement, inability to flush or aspirate, occlusion, therapy interruption, blood loss, tissue irritation, or bloodstream infection.

Which Products Are Affected

The recall covers 6,928 units of the following products distributed in the 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) and internationally (MYS, CAN, SAU):

  • 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 Affected lots include specific expiration dates through December 2026. Recall number Z-2803-2026. Classification: Class II.

What You Should Do

Healthcare providers and facilities should identify and quarantine affected units. Contact Argon Medical Devices, Inc. for return or replacement instructions.

Why This Matters

The defect may interrupt critical intravenous therapies or lead to infection risks in patients requiring central venous access.

Source

FDA recall Z-2803-2026, Argon Medical Devices, Inc., Athens, TX.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Argon Medical Devices, Inc. is recalling 6,928 units of L-Cath PICC catheters due to potential leaking or cracking at the hub.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.