FDAJune 26, 2020device
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provi...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
What to do
FDA enforcement status: Terminated
Brands named
steris
UPCs
111675398011116753980211167539803011675398041216753980611167440102011777359031116753981101177735902011777359010117773590601177735904
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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