The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2708-2026·Announced 2026-07-22

Arterial Line Kit with Lidocaine HCL Injection Fails Sterility Testing

Argon Medical Devices is recalling an Arterial Line Kit containing Lidocaine HCL Injection USP because the kits do not meet sterility release criteria, creating a risk of infection from non-sterile medical injection.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this recall as Class I, which per the rubric requires a severity score of at least 4. Sterility failure in an invasive medical device carries risk of serious infection, meeting the Severe threshold.

Plain-English summary

Argon Medical Devices, Inc is recalling Arterial Line Kit 20ga x 6 (REF: 400115A) containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules. The kits were subject to another recall and were found to not meet release criteria for sterility.

The recall affects 440 units distributed nationwide in the United States, including Puerto Rico, and internationally to Trinidad and Tobago. The affected lot numbers are 11655174, 11655183, 11655185, and 11659131, all with an expiration date of 7/19/2027.

Patients or healthcare providers who have received or are using these kits should stop use immediately and contact their healthcare provider or Argon Medical Devices for instructions on return or replacement. Non-sterile medical devices used in arterial line placement pose a risk of infection.

The recalled product

Product
Arterial Line Kit 20ga x 6, REF: 400115A
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Arterial Access / Injection
Hazard
Affected units
440

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 (3)

  • 11655183(7/19/2027)
  • 11655185(7/19/2027)
  • 11659131(7/19/2027)

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same manufacturer · Argon Medical Devices, Inc

See all →

Same hazard · sterility failure

See all →

Similar recalls