FDA-Device2026-07-22Class IPROCESSING DEFECT
Argon Medical Devices bone marrow tray kits recalled for sterility failure
OTHERNationwide distribution
Argon Medical bone marrow tray recalled for sterility failure
Argon Medical Devices is recalling bone marrow tray kits (models CB0033TL and CB0355TLA) that contain lidocaine injections. The lidocaine ampules in these kits did not meet sterility standards required for safe use. The kits were distributed nationwide and internationally.
- Check if you have a bone marrow tray kit with lot numbers 11650820, 11652276, or 11651977.
- Do not use the kit if you have one of the affected lots.
- Contact Argon Medical Devices or your supplier for instructions on returns or replacement.
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
680
Manufactured in
1445 Flat Creek Rd, Athens, TX, United States
Products
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2709-2026More Argon Medical Devices, Inc recalls
- FDA-Device2026-07-22Argon Medical Devices General Biopsy Tray recalled for sterility concerns
- FDA-Device2026-07-22Argon Medical Devices Arterial Line Kit recalled for sterility test failure
- 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
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