Medical device recalls Moderate risk

Getinge 88-Series Washer- Disinfector recalled over fire hazard

Recall date
August 29, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Getinge Disinfection Ab recalls Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Recall number
Z-0016-2026
FDA classification
Class II
Brand / firm
Getinge Disinfection Ab
Sold / distributed
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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

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