Lower risk Medical device recall · FDA · Published January 16, 2020

Getinge 46-Series Washer Disinfector Missing Water Intake Risk

Getinge 46-Series Washer Disinfector Model 46-4 (serials WAA090630 etc.) may not be properly installed due to missing deionized water intake. No serious injuries reported.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1390-2020Medical device Getinge ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMaquet Cardiovascular Us Sales, Llc45 Barbour Pond Dr · Wayne, NJ 07470-2094

✎ GovInfoNow plain-language explainer

Getinge 46-Series Washer Disinfector Model :46-4 (serials WAA090630, WAA090724, etc.) lacks required deionized water intake components. This could prevent proper installation, but no serious injuries have been reported. Read more at govinfonow.com/recall/65987-getinge-46-series-washer-disinfector-missing-water-intake-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65987-getinge-46-series-washer-disinfector-missing-water-intake-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1390-2020

Cite this page

“Getinge 46-Series Washer Disinfector Missing Water Intake Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65987-getinge-46-series-washer-disinfector-missing-water-intake-risk. Based on FDA recall #Z-1390-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2020%22&limit=1).

Maquet Cardiovascular Us Sales, Llc recalled Getinge 46-Series Washer Disinfectors due to a missing water intake for deionized water, according to the FDA. The Food and Drug Administration announced the Class III recall on Jan. 16, 2020.

How to tell if you have it

Getinge 46-Series Washer Disinfector Model # 46-4
Part Number: 46-4-502
Serial Numbers: WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, WAA092596
UDI Code 07340153700031

The hazard

The units could not be properly installed because there were no valve, hose, or clamps included for the deionized water intake option. There have been no adverse events reported resulting in serious illness or injuries.

Context

GovInfoNow's records show Maquet Cardiovascular Us Sales, Llc has 14 other recalls on record since Oct. 25, 2018. Other recent recalls of similar products include Maquet HLS Set Advanced 5.0 Recall (Nov. 20, 2020) and Maquet BMU 40 Blood Monitor Recall (Sept. 30, 2020).

How to tell if you have this one

Check for serial numbers: WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, WAA092596. The product is used in hospitals, dental clinics, or operating rooms for cleaning surgical equipment.

Brand
Getinge
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class III
Status
Terminated
Distribution
U.S. Distribution: CA, CO, IA, MN, NY, SC, VA

Recall number	Product, codes & lots	Quantity
Z-1390-2020	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.; Serial Numbers: WAA090630, WAA090724, WAA091212, WAA091456, WAA091468, WAA092596. UDI Code 07340153700031	4 units
Z-1391-2020	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.; Serial Numbers: WAA090094, WAA090112, WAA090409, WAA090521, WAA090757, WAA090805, WAA091170, WAA091288, WAA091292, WAA091454, WAA091460 WAA091463, WAA091477. UDI Code 07340153700048	7 units

Based on the official FDA remedy

What to do — step by step

Check Installation
Verify if the device has the required deionized water intake components (valves, hoses, clamps) for proper installation.

Where it went and when

Where it was distributed

Distributed in 7 states.

FDA distribution: “U.S. Distribution: CA, CO, IA, MN, NY, SC, VA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Colorado, Iowa, Minnesota, New York, South Carolina, Virginia.

Recall timeline

FDA terminated this recall 3.8 years after the firm started it.

Jan 16, 2020Firm started the recall
Feb 27, 2020FDA classified it Class III
Mar 4, 2020Published in FDA’s Enforcement Report
Oct 23, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/65987-getinge-46-series-washer-disinfector-missing-water-intake-risk">Getinge 46-Series Washer Disinfector Missing Water Intake Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1390-2020 (January 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1390-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.