Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying
Medical device recall Z-1475-2020. Published in FDA’s Enforcement Report on Mar 18, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 18, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 146 US how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential leakage that may occur due to ruptured spot welds in the chamber, could generate a situation for the user such as risk for slipping or infection from contaminated water
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and drying Model Number: 88-5 Part Number: 88-103; 88-203
146 US, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
ITEM: 88-103: Serial Numbers: SEV0725124 SEV0745196 SEV0832057 SEV0832058 SEV0833080 SEV0833081 SEV0910147 SEV0912065 W50010582 W50010772 W50010773 W50010774 W50011211 W50011212 W50011809 W50011810 W50011811 W50012589 W50013228 W50013359…
Every code shown here, 1,619 characters
ITEM: 88-103: Serial Numbers: SEV0725124 SEV0745196 SEV0832057 SEV0832058 SEV0833080 SEV0833081 SEV0910147 SEV0912065 W50010582 W50010772 W50010773 W50010774 W50011211 W50011212 W50011809 W50011810 W50011811 W50012589 W50013228 W50013359 W50013362 W50013363 W50013983 W50013984 W50014009 W50014080 W50014081 W50014082 W50014338 W50014339 W50014340 W50014425 W50014426 W50015254 W50015255 W50015480 W50015782 W50015964 W50015965 W50015966 W50015967 W50015968 W50017020 W50017021 W50017773 W50017953 W50017954 W50018081 W50018082 W50018188 W50018936 W50018937 W50019170 W50019172 W50020826 W50020827 W50021010 W50021068 W50021080 W50021115 W50021137 W50021169 W50021223 W50021224 W50021225 W50021228 W50021229 W50021326 W50021478 W50021526 W50021527 W50021528 W50021690 W50021723 W50022115 W50022118 W50023119 W50023347 W50023431 W50023468 W50023682 W50023712 W50023723 W50023770 W50023800 W50023801 W50023901 W50023933 W50023963 W50023989 W50024559 W50024606 W50025054 W50025079 W50025083 W50025142 W50025170 W50025204 W50025250 W50026016 W50026072 W50026778 W50026815 W50026954 W50026978 W50026996 W50027987 W50028001 W50028317 W50028353 W50028695 W50028733 W50028854 W50029123 W50029171 W50029201 W50030086 W50030180 W50030184 W50030715 W50031399 W50031975 W50032013 W50032606 W50032634 W50032635 W50032713 W50032773 W50032877 W50032977 W50032978 W50033103 W50033133 W50033645 W50033842 W50033930 W50033998 W50034018 Item Number: 88-203: Serial Numbers: W50034751 W50035168 W50035183 W50035196 W50035635 W50035651 W50035687 W50035704 W50036689 W50036719 W50037076 UDI Code: 88-103 07340153700109; 88-203 07340153700116
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Foreign: Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Iraq, Iran, Ireland, Israel, Italy, Japan, Kenya, Lithuania, Netherlands, New Zealand, Norway, Poland, Qatar, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 10, 2020.
- FDA classified it on Mar 11, 2020.
- FDA’s Enforcement Report published it on Mar 18, 2020.
- FDA terminated it on Sep 13, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Maquet Cardiovascular Us Sales, Llc, of Wayne, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.