Class II

Medical Device Recall: Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

Getinge Disinfection Ab · August 29, 2025

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.

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.

States Affected

NATIONWIDE

Quantity Affected

902 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0016-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Getinge Disinfection Ab Medical Device Recall: Getinge 88-Series Washer- Disinfector. Model Number: 88-5. | SafeCheck