Getinge recalled 788 units of its 88-Series Washer-Disinfector on August 29, 2025. The device may overheat if the circulation pressure calibration is incorrect and the low-pressure alarm fails. This recall affects devices distributed worldwide, including several U.S. states.
Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Getinge Disinfection Ab or your healthcare provider for instructions. Notification method: Letter
The recalled product is the Getinge 88-Series Washer-Disinfector, Model Number 88-5. It is identified by UDI-DI Numbers: 07340153700109 and 07340153700116. The devices were sold worldwide, including in the U.S. states of Colorado, Massachusetts, New Mexico, and New Hampshire.
The recalled Washer-Disinfector poses a high risk of overheating during operation. This can occur if the circulation pressure calibration is not performed correctly or if the low-pressure alarm is not triggered.
No specific incidents or injuries have been reported at this time. The potential for overheating presents a serious safety risk.
Stop using the Washer-Disinfector immediately. Follow the recall instructions provided by the manufacturer. Contact Getinge Disinfection Ab or your healthcare provider for further guidance.
For further assistance, contact Getinge Disinfection Ab. Visit their website or call the customer service line for more information.
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