Servo-i Ventilator
Medical device recall Z-0092-2021. Published in FDA’s Enforcement Report on Oct 21, 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 Oct 21, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 15 states named in where it went
- 431 units 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?
A potentially shorter than specified nebulizer connector may result in difficulty in installing the Aeroneb Nebulizer module to the Servo-i device successfully.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for Neonates, Pediatric and Adults.
431 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot 6487800 Serial numbers 95160 95283 95284 95285 95286 95287 95288 95289 95290 95291 95292 95293 95294 95295 95296 95297 95363 95364 95365 95366 95367 95368 95369 95370 95371 95372 95373 95374 95431 95432 95433 95374 95435 95436 95437…
Every code shown here, 1,995 characters
Lot 6487800 Serial numbers 95160 95283 95284 95285 95286 95287 95288 95289 95290 95291 95292 95293 95294 95295 95296 95297 95363 95364 95365 95366 95367 95368 95369 95370 95371 95372 95373 95374 95431 95432 95433 95374 95435 95436 95437 95438 95439 95440 95441 95442 95455 95456 95457 95458 95459 95460 95461 95462 95463 95464 95465 95466 95467 95468 95469 95470 95471 95472 95473 95474 95475 95476 95477 95478 95880 95881 95882 95883 95884 95885 95886 95887 95888 95889 95890 95891 95892 95893 95894 95895 95896 95897 95898 95899 95900 95901 95902 95903 95904 95905 95906 95907 95908 95909 95910 95911 95912 95913 95914 95915 95916 95917 95918 95919 95920 95921 95922 95923 95924 95925 95926 95927 95928 95929 95930 95931 95932 95933 95934 95935 95946 95947 96018 96019 96020 96021 96022 96023 96024 96025 96026 96027 96028 96029 96050 96051 96052 96053 96054 96055 96056 96057 96058 96059 96060 96061 96062 96063 96064 96065 96066 96067 96068 96069 96070 96071 96072 96073 96145 96146 96147 96148 96149 96150 96151 96152 96153 96154 96155 96156 96157 96158 96159 96160 96161 96162 96163 96164 96165 96166 96167 96168 96169 96170 96171 96172 96173 96174 96796 96797 96798 96799 96800 96801 96802 96803 96804 96885 96886 96887 96888 96889 96890 96891 96892 96893 96894 96895 96896 96897 96898 96899 96900 96901 96902 96903 96904 96905 96906 96907 96908 96909 96910 96911 96912 96913 96914 96915 96916 96917 96918 96919 96920 97045 97046 97047 97048 97049 97050 97051 97052 97053 97054 97055 97056 97057 97058 97059 97060 97061 97062 97063 97064 97065 97066 97067 97068 97069 97070 97071 97072 97073 97074 97075 97076 97077 97078 97079 97080 97149 97150 97151 97152 97153 97154 97155 97156 97157 97158 97159 97160 97161 97162 97163 97164 97165 97166 97167 97168 97169 97170 97171 97172 97173 97174 97175 97176 97177 97178 97179 97180 97181 97182 97183 97184 97185 97186 97187 97188 97189 97190 97191 97192 97193 97194 97195 97196 97197 97198 97199 97200 97201 97202 97203 97204 97205 97206 97207…
FDA’s list runs to 2,612 characters. The first part is shown; the rest is on FDA’s record.
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.
Domestic distribution to AZ CA GA IL MN MO NC NJ NY RI SC TX VA WI WV Foreign distributed to Bosnia and Herzegovina, Czech Republic, France, Germany, India, Indonesia, Iraq, Italy, Kenya, Republic of Korea, Lebanon, Libyan Arab Jamahiriya, Norway, Palestine, Peru, Qatar, Saudi Arabia,Slovakia, Sri Lanka, Sweden Thailand, Turkmenistan, Ukraine and United Arab Emirates.
The states and territories these words name
15 states and territories.
Every one of them
- Arizona
- California
- Georgia
- Illinois
- Minnesota
- Missouri
- North Carolina
- New Jersey
- New York
- Rhode Island
- South Carolina
- Texas
- Virginia
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Sep 17, 2020.
- FDA classified it on Oct 9, 2020.
- FDA’s Enforcement Report published it on Oct 21, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Getinge Group Logistics America, 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.”
- FDA’s list of codes runs to 2,612 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.