The Recall Desk
LowFDA (Devices)·Z-1390-2020·Announced 2020-03-04

Getinge 46-Series Washer Disinfector Recalled Due to Missing Water Intake Components

Maquet Cardiovascular is recalling four Getinge 46-Series Washer Disinfector units because they lack necessary water intake components, preventing proper installation.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, and the source explicitly states that no adverse events or injuries have been reported, fitting the criteria for a low-severity documentation or installation issue.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling four units of the Getinge 46-Series Washer Disinfector, Model # 46-4, Part Number 46-4-502. These devices are used in facilities such as Central Sterile Supply Departments, operating rooms, dental clinics, and hospital wards to clean, disinfect, and dry surgical goods.

The recall is due to a missing water intake for Deionized water. The units were shipped without the necessary valve, hose, or clamps for this option, which means they could not be properly installed. The affected units are identified by serial numbers WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, and WAA092596, and UDI Code 07340153700031.

The devices were distributed in California, Colorado, Iowa, Minnesota, New York, South Carolina, and Virginia. The FDA has not reported any adverse events resulting in serious illness or injuries. Users should contact the recalling firm for instructions on how to proceed.

The recalled product

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
Affected units
4

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Serial Numbers: WAA090630
  • WAA090724
  • WAA091212
  • WAA091456
  • WAA091468
  • WAA092596. UDI Code 07340153700031

Distribution

Distributed in 7 states:

Part of a larger recall action

This product is one of 2 recalled by Maquet Cardiovascular Us Sales, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →