Getinge Disinfection Ab: Device Recall

Recall #Z-0016-2026 · 08/29/2025

Class II: Risk

Recall Details

Recall Number
Z-0016-2026
Classification
Class II
Product Type
Device
Recalling Firm
Getinge Disinfection Ab
Status
Ongoing
Date Initiated
08/29/2025
Location
Vaxjo, N/A, Sweden
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
877 units

Reason for Recall

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.

Product Description

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

Distribution Pattern

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, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Kenya, Korea, Republic of, Kuwait, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.