FDA-Device2026-07-22Class IPACKAGING DEFECT
Argon Medical Devices Arterial Line Kit recalled for sterility test failure
OTHERNationwide distribution
Argon Medical Arterial Line Kit recalled for sterility failure
Argon Medical Devices is recalling certain Arterial Line Kits (model 20ga x 6, REF: 400115A) that contain Lidocaine HCL Injection. These kits failed sterility testing and do not meet safety release criteria. The affected kits have specific lot numbers with expiration dates in July 2027.
- Check if you have one of the affected lots: 11655174, 11655183, 11655185, or 11659131
- Do not use kits from these lots
- Contact your healthcare provider or Argon Medical Devices for instructions on how to return or dispose of the product
Hazard
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Sold states
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
Affected count
440
Manufactured in
1445 Flat Creek Rd, Athens, TX, United States
Products
Arterial Line Kit 20ga x 6, REF: 400115A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2708-2026More Argon Medical Devices, Inc recalls
- FDA-Device2026-07-22Argon Medical Devices General Biopsy Tray recalled for sterility concerns
- FDA-Device2026-07-22Argon Medical Devices pacing electrode trays recalled for sterility failure in lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices One-Piece Introducer Tray recalled for sterility failure in Lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices T-Lok Bone Marrow Tray recalled for sterility failure
- FDA-Device2026-07-22Argon Medical Devices bone marrow tray kits recalled for sterility failure
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