BD Pyxis(TM) Anesthesia Station 4000
Medical device recall Z-1932-2024. 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
- 11,875 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(TM) Anesthesia Station 4000, REF: 338
11,875 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 10885403477829/ Serial Numbers provided 8/27/2025: 15549257 14897663 14895303 14895304 14895305 14895306 14895307 14895308 14895309 14895310 14895311 14877974 14819696 14956425 14956427 14956428 14956429 14956431 14956432 14622884…
Every code shown here, 2,000 characters
UDI: 10885403477829/ Serial Numbers provided 8/27/2025: 15549257 14897663 14895303 14895304 14895305 14895306 14895307 14895308 14895309 14895310 14895311 14877974 14819696 14956425 14956427 14956428 14956429 14956431 14956432 14622884 14622885 15091720 14546469 14361326 14361327 15019611 15019612 15019613 15019614 15019615 15019616 15019617 15019618 15019619 15019620 15289651 14558594 14558595 14558596 14558597 14558598 14558599 14558600 14558601 14558602 14558604 14558605 14558606 14558607 14384234 14384236 14384238 14384240 14384241 14384243 14384244 14384245 14384246 14384247 14384248 13932078 13932079 13932080 13932081 15507816 14379194 14379727 14379729 14379730 14379731 14379732 14379733 14379734 14379735 14379736 14379737 14379738 14379740 14379741 14379811 14379812 14379813 14379816 14379817 14379972 14379973 14379974 14379975 14379718 14379719 14379720 14379721 14379722 14379723 14379724 14379725 14379726 13859536 13859549 14544175 14544176 14544178 14544180 14544181 14567021 14544171 14544172 14544174 14544158 14544159 14544160 14544161 14544162 14544163 14544165 14544167 14544168 14544169 14544170 14385503 13970089 13970091 13970093 13970096 13970097 13970099 13970102 13970106 13970110 13970111 13970112 13970113 15159053 15159054 15159055 15159056 14292960 14292961 14292962 14292963 14292964 14292965 14292966 14292967 14292968 14292970 14292973 14292974 14292975 14292976 14292977 14292978 14292979 14292981 14292983 14292985 15263558 14472899 14380818 14039816 14039817 14039818 14039819 14039820 14039822 14039824 14039825 14039826 14039827 14039828 14039829 14039830 14039831 14039832 14039833 14039834 14039835 14039836 14039837 14039838 14039839 14039840 14039841 13908525 13908526 13908527 13908528 13908529 13908530 13908531 13908532 13888650 13888651 13888654 13888656 14956440 13908513 13908514 13908515 13908516 13908517 13908518 13908519 13908520 13908521 13908522 13908523 13908524 14628633 14627521 14610330 14610331 14610332 14610333 14610334 14610335…
FDA’s list runs to 118,321 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 118,321 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.