Getinge Disinfection Ab recalls Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0016-2026
• FDA device classification · MECOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.6992The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Getinge Disinfection AbSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.