GETINGE 88-SERIES recallZ-0016-2026 · Getinge Disinfection Ab · initiated Aug 29, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Getinge Disinfection Ab or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company is doing
Getinge notified consignees on about 08/29/2025 via letter. Consignees were instructed that Getinge service technicians will be proactively reaching out to ensure affected devices are calibrated appropriately. In the meantime, Getinge has developed a verification procedure to ensure that the circulation pressure in standby mode is correctly calibrated to 0.0 kPa. If the value deviates, recalibration by a qualified technician is required. The verification of the circulation pressure shall be performed by the operator or Getinge technician. If the value deviates from 0.0 kPa out of allowed tolerances (1 kPa), stop using the device immediately and work with your Getinge service technician to arrange recalibration. Consignees were also instructed to ensure all caregivers and users of the affected product are made aware of the recall and to complete and return the provided response form. ***UPDATE 10/16/2025: Firm notified FDA of an expansion to include additional OUS units and one additional complaint. ***UPDATE 03/02/2026: Firm notified FDA of an expansion to include additional OUS units and one additional complaint.
Recall details
- Recall number
- Z-0016-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 29, 2025
- Posted by the FDA
- Oct 1, 2025
- Recalling firm
- Getinge Disinfection Ab
- Quantity
- 902 units
- Product code
- MEC
- 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.
Product description
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Code information (models, lots, serial numbers)
Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- GETINGE 88-SERIES 88-5Getinge Disinfection AB · Disinfector, Medical Devices3 recalls6 reports
- GETINGE 88-SERIES 88-5Getinge Disinfection AB · Disinfector, Medical Devices3 recalls0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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