Argon Medical Devices, Inc: Instrument, Biopsy

Recalling firm
Argon Medical Devices, Inc
Product
General Biospy Tray, REF: GUTS1000
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/d7e74b24-e221-46c3-89a3-b1c419800989