Getinge 88-Series Washer (Getinge) – Overheating Potential (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Brand
Getinge Disinfection Ab Ljungadalsgatan
Lot Codes / Batch Numbers
Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
Products Sold
Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
Getinge Disinfection Ab Ljungadalsgatan is recalling Getinge 88-Series Washer- Disinfector. Model Number: 88-5. due to Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for device to overheat during operation f the circulation pressure calibration was not performed or had been performed incorrectly, and the low-pressure alarm is not triggered.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026