Getinge 46-Series Washer Disinfector Model # 46-4 — Class III medical device recall Z-1390-2020

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-1390-2020`
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	4 units
UPC / GTIN / UDI-DI	`07340153700031`
Serial numbers	`WAA090630`, `WAA090724`, `WAA091212`, `WAA091456`, `WAA091468`, `WAA092596`
Model numbers	`46-4`, `46-4-502`

Product

Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 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-1390-2020. 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.