FDA recall Z-2706-2026

Argon Medical Devices, Inc · Class I · device

Product

General Biospy Tray, REF: GUTS1000

Reason for recall

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

Distribution

Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.

Key facts

Status: Ongoing
Initiation date: 2026-06-01
Report date: 2026-07-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Athens, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2706-2026