Official recall notice

FDA DeviceClass INotable

FDA Recall: General Biospy Tray, REF: GUTS1000

Recall date
2026-07-22
FDA class
Class I

Why it was recalled

Hazard

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

Product description

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

Affected products

REF/UDI-DI Box:Unit/Lot(Expiration): GUTS1000/20886333001594:00886333001590/11649760(3/31/2028)

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