FDA-Device2026-07-22Class IPROCESSING DEFECT
Argon Medical Devices bone marrow tray kits recalled for sterility failure
What this means
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.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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-2709-2026Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.