Summary
The FDA issued a Class II for Getinge 88-Series Washer- Disinfector. Model Number: 88-5. by Getinge Disinfection Ab. Reason: Potential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and the.
Details
Source
Device Recall
External ID
Z-0016-2026
Action Date
2025-10-08
Status
Ongoing
Category
device
Product Description
Getinge 88-Series Washer- Disinfector. Model Number: 88-5.
Lot/Code Info: Model Number: 88-5. UDI-DI Numbers: 07340153700109, 07340153700116. Software Version: GD 14080 Rev A. All Lot Numbers with electrical heating.
Quantity Affected: 902 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-29
Company
Vaxjo, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Getinge Disinfection Ab has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Getinge Disinfection Ab) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Getinge Disinfection Ab have FDA actions?
Getinge Disinfection Ab has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0016-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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