CLASS II ONGOING Device recall · Reported 8 Oct 2025 · FDA Enforcement Report
Getinge 88-Series Washer- Disinfector recalled
Getinge Disinfection Ab is recalling Getinge 88-Series Washer- Disinfector, distributed nationwide in the US. The recall was initiated on 29 Aug 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0016-2026
- FDA event ID
- 97535
- Recalling firm
- Getinge Disinfection Ab, Vaxjo, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Aug 2025
- FDA classified
- 1 Oct 2025
- Reported
- 8 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 29 Aug 2025 | Recall initiated by company | |
| 1 Oct 2025 | Classified by FDA | +33 days |
| 8 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Getinge Disinfection Ab
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Washer Disinfector Aquadis recalled by Getinge Disinfection Ab | Getinge Disinfection Ab | Packaging Defects | Nationwide |
| Device | CLASS II | Washer Disinfector Aquadis recalled by Getinge Disinfection Ab | Getinge Disinfection Ab | Packaging Defects | Nationwide |
| Device | CLASS II | Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled | Getinge Disinfection Ab | Other | Nationwide |
| Device | CLASS II | Getinge Ags, Fslc, Fsuc, RC accessory to Washer recalled | Getinge Disinfection Ab | Other | Nationwide |
| Device | CLASS III | Getinge 86 Series Washer/Disinfector with G1 control system recalled | Getinge Disinfection Ab | Foreign Material | 12 states |
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