Getinge Disinfection Ab — Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 29, 2025
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.
What's affected?
- Product
- Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
- Lot code
- with
Additional details
Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 902 units.
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