Alaris EtCO2
Medical device recall Z-2443-2019. Published in FDA’s Enforcement Report on Sep 11, 2019.
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 Sep 11, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 10 states named in where it went
- 76 EtCO2 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?
Calibration; it has been determined that the capnographs may have been calibrated during manufacturing using a lower than specified concentration of CO2
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
76 EtCO2 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial #/Model # 15098573 11634567; 15111502 11634567; 15096360 11634567; 15098699 11634567; 15099681 11634567; 15096411 11634567; 15091045 11634567; 15095827 11634567; 15090452 11634567; 15091016 11634567; 15091061 11634567; 15102989…
Every code shown here, 1,511 characters
Serial #/Model # 15098573 11634567; 15111502 11634567; 15096360 11634567; 15098699 11634567; 15099681 11634567; 15096411 11634567; 15091045 11634567; 15095827 11634567; 15090452 11634567; 15091016 11634567; 15091061 11634567; 15102989 11634567; 15096388 11634567; 15098536 11634567; 15098577 11634567; 15099809 11634567; 15099880 11634567; 15100031 11634567; 15101644 11634567; 15101802 11634567; 15102453 11634567; 15102532 11634567; 15091069 11634567; 15091118 11634567; 15102694 11634567; 15095732 11634567; 15095813 11634567; 15095837 11634567; 15095838 11634567; 15095745 11634567; 15096145 11634567; 15096189 11634567; 15096165 11634567; 15096179 11634567; 15096789 11634567; 15098732 11634567; 15101800 11634567; 15101856 11634567; 15101878 11634567; 15101902 11634567; 15101956 11634567; 15101984 11634567; 15102450 11634567; 15102465 11634567; 15102463 11634567; 15102547 11634567; 15102604 11634567; 15102565 11634567; 15102627 11634567; 15102639 11634567; 15102674 11634567; 15102901 11634567; 15102911 11634567; 15104015 11634567; 15104017 11634567; 15104041 11634567; 15102955 11634567; 15090987 8300ADXEN933; 15091002 8300ADXEN933; 15091053 8300ADXEN933; 15091228 8300ADXEN933; 15091270 8300ADXEN933; 15091272 8300ADXEN933; 15091274 8300ADXEN933; 15091297 8300ADXEN933; 15091311 8300ADXEN933; 15091350 8300ADXEN933; 15091321 8300ADXEN933; 15091347 8300ADXEN933; 15091352 8300ADXEN933; 15095743 8300ADXEN933; 15095794 8300ADXEN933; 15095805 8300ADXEN933 15101540 8300ADXEN933; 14976629 8300ADXEN933
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.
US: KY, TX CA, IL, MN, NC, IA, SD, KS, DC OUS: Australia
The states and territories these words name
- California
- District of Columbia
- Iowa
- Illinois
- Kansas
- Kentucky
- Minnesota
- North Carolina
- South Dakota
- Texas
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?
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 Jul 1, 2019.
- FDA classified it on Aug 30, 2019.
- FDA’s Enforcement Report published it on Sep 11, 2019.
- FDA terminated it on Sep 9, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CareFusion 303, Inc., of San Diego, CA.
- 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
-
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.