Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Caviwave Pro Ultrasonic Cleaning System Recalled by Steris Corporation Due to Should the Caviwave Pro Ultrasonic Cleaning System experience...

Date: February 19, 2015
Company: Steris Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Steris Corporation directly.

Affected Products

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.

Quantity: 491 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Steris Corporation

Steris Corporation has 109 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report