Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GETINGE 46-SERIES Medical Washer-Disinfector Recalled by Getinge Disinfection Ab Due to Getinge Disinfection AB received complaints regarding sediment residuals...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Getinge Disinfection Ab directly.
Affected Products
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from 510(k) requirements. For use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Quantity: 551 total: USA: 547 units, Canada: 4 units
Why Was This Recalled?
Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS 300/350 control. After performing detailed root cause analysis, the firm has identified the problem as insufficient water flow throughout the manifold due to formation of air pockets where sedimentation may occur.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Getinge Disinfection Ab
Getinge Disinfection Ab has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report