FDA Medical Device Recalls (openFDA)
Getinge Disinfection Ab: Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
- Recall number
- Z-0016-2026
- Recalling firm
- Getinge Disinfection Ab
- Product
- Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
- Status
- Open, Classified
- Initiated
- 2025-08-29
- Posted
- 2025-10-01
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 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, 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.
- Lot, serial or model codes
- Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MEC
- Firm FEI
- 3000231474
- Firm city
- Vaxjo
- Firm state
- not on file
- Firm country
- Sweden
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28