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Getinge Disinfection Ab recalls Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Recalled October 8, 2025 · FDA recall Z-0016-2026 · Getinge Disinfection Ab
Hazard
Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered. · FDA Class II
Units
902 units
Sold at
Worldwide - US Nationwide distribution in the states of Colorado, Massachusetts, New Mexico, New Hampshire and the countries of Algeria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Austria, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Kenya, Korea, Republic of, Kuwait, Lithuania, Mexico, Netherlands, Norway, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.
Description
Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Product
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Manufacturer(s)
Getinge Disinfection Ab
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →