Recall Z-0016-2026— Getinge Disinfection Ab
Class II · Ongoing
Class II FDA medical device recall by Getinge Disinfection Ab, initiated 2025-08-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Getinge 88-Series Washer- Disinfector. Model Number: 88-5.. Reason: 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
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-08-29
- Firm location
- Vaxjo, N/A, Sweden
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.