GETINGE 46-SERIES Medical Washer-Disinfector — Class II medical device recall Z-0852-2015
Terminated recall by Getinge Disinfection Ab, reported 2014-12-31, distributed nationwide. Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and dis
| Recall number | Z-0852-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Disinfection Ab, Vaxjo, Sweden |
| Recall initiated | 2014-11-26 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2017-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Serial numbers | SEV0515157, SEV0515159, SEV0521184, SEV0521186, SEV0521187, SEV0521190, SEV0521191, SEV0521192, SEV0524327, SEV0524333, SEV0524334, SEV0524337, SEV0524338, SEV0532062, SEV0533065, SEV0533067, SEV0533068, SEV0533069, SEV0533070, SEV0533071, SEV0534064, SEV0534069, SEV0534074, SEV0536194, SEV0536195 and 475 more |
| Model numbers | 46-4, 46-5 |
Product
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.
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.