HIGHFDA DEVICE

Arterial Line Kit 20ga x 6, REF: 400115A

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

Argon Medical DevicesHealth & Personal CareMedical DevicesREF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027)11655183(7/19/2027)11655185(7/19/2027)

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
June 1, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
June 1, 2026
Hazard Level
HIGH
Brand
Argon Medical Devices
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Argon Medical Devices
Model numbers
REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027), 11655183(7/19/2027), 11655185(7/19/2027), 11659131(7/19/2027)
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    June 1, 2026

  2. Reported by FDA DEVICE

    July 22, 2026

  3. RecallRadar source check

    July 28, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Argon Medical Devices, Inc or your healthcare provider for instructions. Notification method: Letter

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Full Description

Arterial Line Kit 20ga x 6, REF: 400115A. Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.. Classification: Class I. Quantity: 440. Distribution: Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
REF/UDI-DI Box:Unit/Lot(Expiration): 400115A/20886333212884:00886333212880/11655174(7/19/2027)
11655183(7/19/2027)
11655185(7/19/2027)
11659131(7/19/2027)
Affected States
ALL
Report Date
July 22, 2026
Recall Status
ACTIVE

Related Recalls

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Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

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