Argon Medical Devices, Inc recalls General Biospy Tray

Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.

On 6/1/2026, correction notices were sent to customers who were asked to do the following: 1) Do not use the affected Lidocaine vials included in affected Kits and Sets in scope of this notice 2) Review your inventory for any product covered by this Medical Device Notification. If any items from the affected lot are identified: - Place a copy of this notice with the affected product - Apply the enclosed stickers to the packaging (kit) to clearly identify the item and remind users to discard affected lidocaine. 3) At the point of use, upon opening the kit, discard the affected Lidocaine vials in accordance with your facility's procedures. 4) Obtain Lidocaine separately through your facility pharmacy and prepare / administer it per institutional protocols prior to the procedure. 5) Complete and return the response form via email Arbee.cummings@argonmedical.com

• FDA enforcement recordOfficial FDA database entry for Z-2706-2026
• FDA 510(k) clearance · K980196The device's official FDA premarket clearance record
• FDA device classification · KNWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1075The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Argon Medical Devices, IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.