Home / Recalls / Getinge Disinfection Ab / Z-0016-2026

Z-0016-2026 Class II Ongoing

Recalled by Getinge Disinfection Ab — Vaxjo, N/A

FDA device recall Z-0016-2026 was initiated by Getinge Disinfection Ab on August 29, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 902 units.

Recall Details

Product Type: Devices
Report Date: October 8, 2025
Initiation Date: August 29, 2025
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 902 units

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.

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, 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.

Other recalls by Getinge Disinfection Ab

Z-1720-2025 Class II — Washer Disinfector Aquadis 56; Model Number: 56A (April 2, 2025)
Z-1721-2025 Class II — Washer Disinfector Aquadis 56; Model Number: 56M (April 2, 2025)
Z-1379-2018 Class II — Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: (March 2, 2018)
Z-1380-2018 Class II — Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: (March 2, 2018)
Z-2419-2015 Class III — Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 (June 26, 2015)
Z-0852-2015 Class II — GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 30 (November 26, 2014)
Z-0018-2014 Class II — Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usag (July 30, 2013)