FDAFebruary 19, 2015device
Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. In addition, it is possible that the ultrasonic generator may stop working. The machine does not provide an alert notifying the user of this device malfunction.
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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