BD Pyxis MedStation 4000 System
Medical device recall Z-1928-2024. 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
- 91,933 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 MedStation 4000 System, REF: 303, Medication Cabinet
91,933 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 10885403512629/Serial numbers added 8/27/2025: 13811918 13811919 8000118765 8000118766 12761424 12761425 12740622 12731265 12558708 15686451 15686452 15686453 15686454 15616386 15616388 15563539 15544140 15544141 15544142 15406815…
Every code shown here, 2,000 characters
UDI: 10885403512629/Serial numbers added 8/27/2025: 13811918 13811919 8000118765 8000118766 12761424 12761425 12740622 12731265 12558708 15686451 15686452 15686453 15686454 15616386 15616388 15563539 15544140 15544141 15544142 15406815 15406817 15076403 15067076 15067081 15067083 15067085 15067088 15067091 15067095 15067096 15067098 15067099 15067100 15067103 15067104 15067108 15067109 15067110 15067111 15053373 15053374 15026036 15026038 14838460 14808782 14808783 14791224 14785171 14785172 14785173 14785174 14785175 14785176 14785177 14785178 14785179 14785180 14785181 14773852 14773853 14773855 14760077 14755527 14755528 14755529 14755530 14755531 14755532 14755533 14755534 14755535 14755536 14754778 14740957 14740958 14740959 14740960 14740961 14740962 14731697 14731699 14731700 14731701 14731702 14731703 14731704 14731705 14731706 14731707 14731708 14731709 14728147 14728148 14728149 14728150 14728151 14707852 14707853 14707854 14690161 14690162 14690163 14690165 14690167 14690168 14689034 14689041 14689042 14689043 14689044 14689045 14689046 14689047 14689048 14671931 14671932 14671933 14671934 14671935 14671936 14671937 14671938 14671939 14671943 14661055 14661056 14661057 14659557 14659558 14659559 14659560 14659561 14659562 14659565 14659566 14659567 14659568 14637284 14637285 14637292 14637293 14637295 14637297 14637298 14633424 14633425 14633426 14633427 14633428 14633429 14633437 14633439 14633440 14608821 14608822 14607298 14607300 14607301 14607302 14607303 14607304 14607305 14607315 14607317 14591184 14591187 14591188 14591189 14591190 14591191 14591192 14591193 14591194 14591195 14591196 14591197 14580305 14580307 14580310 14580314 14580315 14580316 14580317 14580318 14580319 14580320 14565979 14565980 14565998 14565999 14566000 14566001 14566002 14566003 14566004 14566005 14566006 14566007 14518498 14598304 14598305 14598306 14598307 14598308 13534422 14906228 14906230 14906232 14906234 14906236 14724815 14724816 14724817 14724818 14724819 14724820…
FDA’s list runs to 915,697 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 915,697 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.