SeriousFDAOngoing
Can cause serious harm or death.
General Biospy Tray, REF: GUTS1000
Check the device or its packaging for
REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)
- Why
- Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.
- Distributed
- Distribution US nationwide including Puerto Rico; OUS to Trinidad and Tobago.
- Company
- Argon Medical Devices, Inc
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2706-2026 · retrieved 10 July 2026
Read the official notice