The Recall Desk
LowFDA (Devices)·Z-1391-2020·Announced 2020-03-04

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

Maquet Cardiovascular is recalling 7 Getinge 46-Series Washer Disinfector units because they lack the necessary water intake components for 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 text explicitly states that no adverse events or injuries have been reported. The issue is a missing component preventing proper installation, which fits the criteria for a low-severity documentation or packaging-only problem.

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling 7 units of the Getinge 46-Series Washer Disinfector Model # 46-4 (Part Number: 46-4-503). 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 required valve, hose, or clamps for this option, meaning they could not be properly installed. The affected units are 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 associated with this recall. Users should contact the manufacturer for instructions on how to resolve the installation issue.

The recalled product

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
Manufacturer
Maquet Cardiovascular Us Sales, Llc
Category
Medical Device — Washer Disinfector
Hazard
Affected units
7

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 (12)

  • Serial Numbers: WAA090094
  • WAA090112
  • WAA090409
  • WAA090521
  • WAA090757
  • WAA090805
  • WAA091170
  • WAA091288
  • WAA091292
  • WAA091454
  • WAA091460 WAA091463
  • WAA091477. UDI Code 07340153700048

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 →

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Same manufacturer · Maquet Cardiovascular Us Sales, Llc

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Same hazard · installation defect

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