FDA Device recall Z-0016-2026
Getinge 88-Series Washer- Disinfector
- FDA Device
- Class II
- ongoing
- Published 2025-10-08
On 2025-10-08 the FDA classified a Class II recall of Getinge 88-Series Washer- Disinfector by Getinge Disinfection Ab, citing 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 tr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0016-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-29 |
| Published | 2025-10-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Getinge Disinfection Ab |
| Distribution | US |
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.
Identifiers
| code_info | Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Getinge Disinfection Ab
- Washer Disinfector Aquadis 56
FDA Device · Class II · 2025-05-14 · Getinge Disinfection Ab - Washer Disinfector Aquadis 56
FDA Device · Class II · 2025-05-14 · Getinge Disinfection Ab - Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 88 Series UDI Info: 07340153700109, 07340153700116 Getinge automated loading/u…
FDA Device · Class II · 2018-04-25 · Getinge Disinfection Ab - Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 0734015370025…
FDA Device · Class II · 2018-04-25 · Getinge Disinfection Ab - Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668
FDA Device · Class III · 2015-08-26 · Getinge Disinfection Ab
All Getinge Disinfection Ab recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0016-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.