FDAClass IJuly 22, 2026

Arterial Line Kit 20ga x 6 recall: Sterility Concern

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

Why was Arterial Line Kit 20ga x 6 recalled?

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 should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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);

Product
Arterial Line Kit 20ga x 6, REF: 400115A
Recalling firm
Argon Medical Devices, Inc
Quantity
440
Distribution
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Recall date
July 22, 2026
Classification
Class I
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls