Getinge 88-Series Washer- Disinfector. Model Number: 88-5.

FDA device recall Z-0016-2026 · posted 2025-10-01 · Open, Classified

Recall details

Recalling firm

Getinge Disinfection Ab

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MEC

Quantity affected

902 units

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, Cze

Date initiated

2025-08-29

Date posted

2025-10-01

Location

Vaxjo, Sweden