Gyrus ACMI Corporation Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray
Brand
Gyrus ACMI Corporation
Lot Codes / Batch Numbers
Product distributed prior to May 7, 2007.
Products Sold
Product distributed prior to May 7, 2007.
Gyrus ACMI Corporation is recalling Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT Cyber due to Sterilization Instructions not adequate for sterilizing.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterilization Instructions not adequate for sterilizing.
Recommended Action
Per FDA guidance
Gyrus has informed their sales force to visit each customer that has a CyberWand system(s) and hand deliver a letter, dated May 23, 2007, that explains the situation and requests that the customer cease using the unit and segregate it to prevent accidental use. The letter also explains that the firm is collecting any sterilization trays with printed sterilization instructions and replacing them. The rep will assist the customer in complying. The customer will also be required to complete a reply form to track compliance.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026