Argon Medical Devices, Inc: Instrument, Biopsy

Recall Summary Argon Medical Devices is recalling Bone Marrow Tray kits (models CB0033TL and CB0355TLA) distributed nationwide because they contain Lidocaine anesthetic ampules that failed sterility testing standards. The affected kits were distributed throughout the United States, Puerto Rico, Trinidad and Tobago, and Washington D.C.

Recalling firm
Argon Medical Devices, Inc
Product
Bone Marrow Tray, REF: CB0033TL; CB0355TLA
Reason
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
Classification
Class II
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-06-01
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/2edce941-8874-4ae5-a9a1-43b27ecde6cb