BD Pyxis” Anesthesia Station ES
Medical device recall Z-1931-2024. Published in FDA’s Enforcement Report on Jun 5, 2024.
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 Jun 5, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 53 states named
- 71,569 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?
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BD Pyxis” Anesthesia Station ES, REF: 327
71,569 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 10885403512636/Serial numbers added 8/27/2025: 15662739 15662740 15662741 15662743 15662745 15662746 15662747 15662749 15662752 15662753 15662754 15662756 15662758 15662759 15662760 15662761 15662762 15662763 15662764 15662765…
Every code shown here, 1,996 characters
UDI: 10885403512636/Serial numbers added 8/27/2025: 15662739 15662740 15662741 15662743 15662745 15662746 15662747 15662749 15662752 15662753 15662754 15662756 15662758 15662759 15662760 15662761 15662762 15662763 15662764 15662765 15662767 15662768 15662769 15662770 15662771 15662772 15662773 15662774 15662775 15375059 15757979 15757980 15755213 15755214 15755215 15755216 15755217 15755218 15022893 15022894 15022895 15022896 14284496 14284498 17700227 17414413 17276726 17215411 15689985 15689986 15566064 15566065 15566067 15566068 15566069 15566070 15566071 15566072 15566073 15566074 15566075 15566076 15566077 15566078 15566079 15540267 15540268 15540270 15540271 15540272 15540273 15540274 15540276 15540277 15540278 15540279 15540280 15540282 15540283 15540284 15540285 15519753 15519754 15519755 15519756 15519757 15519758 15519759 15519760 15519761 15519762 15519763 15519764 15519765 15519766 15519767 15503435 15503437 15503439 15503441 15503443 15503444 15503445 15503447 15503448 15503450 15503452 15503453 15503454 15503456 15503457 15248264 15248266 15248267 15106149 15106150 15106151 15106152 15087939 15087940 15087941 15087942 15087943 15087944 15087945 15087947 15087948 15087951 15087952 15087954 15087955 15087956 15087957 15087958 15087959 15087960 15087961 15087962 15087963 15052089 15052090 14914250 14826833 14826834 14826835 14826836 14826837 14826838 14597398 14597399 15603399 15603401 15603402 15603403 15603404 15581896 17356056 17356058 17356060 17356061 17356062 14782343 14487085 14487091 14487092 14487095 14487096 14487097 14487098 14487099 14487101 14487102 14487103 14487104 14487105 14487106 14487108 14486068 14486069 14486070 14486071 14486072 14486073 14486074 14486075 14486076 15492383 14520920 14520921 14520922 14520924 14520925 14520926 14520927 14520928 14520929 14520930 14520931 14520932 14520933 14520934 14520935 14520937 15592931 15592932 15592933 15592934 15592937 15592938 15592939 15592941 15592943 15592944 15592945 15592946 15592947…
FDA’s list runs to 650,415 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.
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of South Africa, Kuwait, Qatar, Singapore, Bermuda, United Arab Emirates, Argentina, Australia, Belgium, Bahrain, Brazil, Bahamas, Canada, Chile, China, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Italy, Japan, South Korea, Lebanon, Morocco, Mexico, New Zealand, Oman, Portugal, Thailand, Taiwan.
The states and territories these words name
53 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Northern Mariana Islands
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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?
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 Apr 15, 2024.
- FDA classified it on May 30, 2024.
- FDA’s Enforcement Report published it on Jun 5, 2024.
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.
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 650,415 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
-
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.