Getinge 46-Series Washer Disinfector Model # 46-4 — Class III medical device recall Z-1391-2020
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2020-03-04, distributed in CA, CO, IA, MN, NY, SC, VA. Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no v
| Recall number | Z-1391-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2020-01-16 |
| Classified | 2020-02-27 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2023-10-23 |
| Distributed | CA, CO, IA, MN, NY, SC, VA |
| Quantity | 7 units |
| UPC / GTIN / UDI-DI | 07340153700048 |
| Serial numbers | WAA090094, WAA090112, WAA090409, WAA090521, WAA090757, WAA090805, WAA091170, WAA091288, WAA091292, WAA091454, WAA091460, WAA091463, WAA091477 |
| Model numbers | 46-4, 46-4-503 |
Product
Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-503 Product Usage: Used in facilities such as Central Sterile Supply Departments, next to the Operating Room, in dental clinics or hospital wards to clean, thermally or chemically disinfect and dry surgical goods.
Reason for recall
Due to a missing water intake for Deionized water on the Getinge 46-Series Washer Disinfector. There were no valve, hose, or clamps for this option included with the device therefore the units could not be properly installed. There have been no adverse events reported resulting in serious illness or injuries.
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-1391-2020. 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.