Getinge 46-Series Medical Washer-Disinfectors — Class II medical device recall Z-0018-2014
Terminated recall by Getinge Disinfection, reported 2013-10-23, distributed nationwide. Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-h
| Recall number | Z-0018-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Getinge Disinfection, Vaxjo, Sweden |
| Recall initiated | 2013-07-30 |
| Classified | 2013-10-17 |
| Reported by FDA | 2013-10-23 |
| Terminated | 2015-05-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | device malfunction |
| Model numbers | 46-4 |
Product
Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes.
Reason for recall
Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0018-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.