FDASeptember 3, 2015device
AMSCO 400 and AMSCO C Small Steam Sterilizers
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door.
What to do
FDA enforcement status: Terminated
Brands named
steris
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAALYON Surgical Lighting System2026-05-15
- FDAHarmonyAIR A-Series Surgical Lighting System2026-05-15
- FDAHarmonyAIR A-Series Surgical Lighting System2026-05-15
- FDAAMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (...2025-11-19
- FDAAMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the cleaning and intermediate-level disinfection of soiled reusable simple hard-surfaced rigid surgical instruments (such as forceps and clamps), utensils (...2025-11-19
- FDADual Flat Panel Monitor (DFPM) accessories for HarmonyAIR E-Series Surgical Lighting Systems2025-06-23
- FDADual Flat Panel Monitor (DFPM) accessories for HarmonyAIR A-Series Surgical Lighting Systems2025-06-23
- FDABarco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H2025-05-23
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