FDA-Device2026-07-22Class IPROCESSING DEFECT
Argon Medical Devices T-Lok Bone Marrow Tray recalled for sterility failure
What this means
Argon Medical Devices is recalling T-Lok Bone Marrow Tray kits that contain Lidocaine HCL Injection ampules. These kits failed to meet sterility standards during quality testing. The affected kits were distributed nationwide and internationally.
- Check if you have one of the affected kits (REF: BMT1104STL, BMET1104TL, or BMT1104CATL).
- Do not use the kit if the lot number matches those listed in the recall.
- Contact Argon Medical Devices or your supplier for instructions on return 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
850
Manufactured in
1445 Flat Creek Rd, Athens, TX, United States
Products
T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2707-2026More Argon Medical Devices recalls
- FDA-Device2026-07-22Argon Medical Devices bone marrow tray kits recalled for sterility failure
- FDA-Device2026-07-22Argon Medical Devices One-Piece Introducer Tray recalled for sterility failure in Lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices pacing electrode trays recalled for sterility failure in lidocaine ampules
- FDA-Device2026-07-22Argon Medical Devices Arterial Line Kit recalled for sterility test failure
- FDA-Device2026-07-22Argon Medical Devices General Biopsy Tray recalled for sterility concerns
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