Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
FDA Recall #Z-0016-2026 — Class II — August 29, 2025
Product Description
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Reason for Recall
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.
Recalling Firm
Getinge Disinfection Ab — Vaxjo, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
902 units
Distribution
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.
Code Information
Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.