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U.S. Department of Health and Human Services

Class 2 Device Recall Getinge 88Series Washer Disinfector

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 Class 2 Device Recall Getinge 88Series Washer Disinfectorsee related information
Date Initiated by FirmAugust 29, 2025
Date PostedOctober 01, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0016-2026
Recall Event ID 97535
Product Classification Disinfector, medical devices - Product Code MEC
ProductGetinge 88-Series Washer- Disinfector. Model Number: 88-5.
Code Information Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
FEI Number 3000231474
Recalling Firm/
Manufacturer		 Getinge Disinfection Ab
Ljungadalsgatan 11
Vaxjo Sweden
Manufacturer 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.
FDA Determined
Cause 2		Under Investigation by firm
ActionGetinge 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.
Quantity in Commerce902 units
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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