BD Pyxis MedStation ES
Medical device recall Z-0670-2025. Published in FDA’s Enforcement Report on Dec 18, 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 Dec 18, 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 54 states named
- 98,526 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?
Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BD Pyxis MedStation ES, REF: 323
98,526, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All software versions. REF/UDI-DI: 323/10885403512667/ 12441103 12440974 12440975 12441333 12441432 12447684 12455493 12455498 12455492 12455793 12458864 12463612 12470842 12476547 12482532 12483393 12486737 12499043 12499838 12499616…
Every code shown here, 1,999 characters
All software versions. REF/UDI-DI: 323/10885403512667/ 12441103 12440974 12440975 12441333 12441432 12447684 12455493 12455498 12455492 12455793 12458864 12463612 12470842 12476547 12482532 12483393 12486737 12499043 12499838 12499616 12499617 12499618 12505982 12508303 12514216 12514218 12514217 12514220 12515358 12522942 12527930 12528710 12528709 12530090 12531418 12537364 12537363 12537076 12540196 12540194 12540267 12540268 12540269 12561139 12568697 12569170 12570749 12570750 12570745 12570746 12570748 12570753 12585184 12585183 12586285 12589659 12589685 12589658 12589618 12589657 12593259 12594318 12594322 12596587 12596404 12597477 12597478 12597479 12597474 12597489 12597491 12597492 12597493 12597475 12598838 12599570 12599571 12599063 12599064 12599065 12599067 12599069 12599066 12599070 12599061 12599062 12599135 12599136 12599138 12599140 12599137 12599141 12599139 12599971 12600268 12599970 12600435 12600467 12600468 12600469 12600690 12600687 12600689 12600691 12602140 12602358 12602360 12602357 12602359 12602372 12602361 12605985 12606524 12608631 12611808 12611816 12611926 12612669 12612567 12615383 12616239 12624466 12626212 12629311 12629309 12629602 12629604 12629603 12629627 12630890 12632195 12633312 12638031 12637962 12637963 12637961 12638017 12638018 12639538 12650679 12650091 12652625 12653147 12653602 12655694 12656692 12656693 12656812 12658185 12659515 12662647 12662921 12666199 12666200 12676117 12678689 12681469 12681569 12683904 12685086 12685088 12685085 12685090 12685091 12685137 12685087 12685089 12686327 12687145 12687229 12688452 12688464 12688454 12690063 12693218 12693928 12693868 12693933 12693869 12693870 12695277 12695293 12695764 12696506 12696505 12696508 12696507 12696750 12696764 12696748 12696749 12696763 12697337 12697340 12697336 12697339 12697341 12697335 12698086 12698076 12697996 12698384 12699329 12699611 12701481 12702050 12702960 12702974 12703634 12703641 12704148 12704149 12704840 12704844 12705614 12705641…
FDA’s list runs to 886,930 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 OK, LA, FL, AR, VA, KY, PA, AL, NC, CA, MN, AK, TX, MI, ME, OH, OR, NY, IL, RI, GA, WI, NH, KS, CO, WA, MO, MD, AZ, SC, NV, WV, NM, IN, NJ, TN, DE, MT, MA, VT, DC, NE, CT, ID, WY, MS, UT, HI, IA, SD, ND, GU, MP, PR and the countries of CA, BR, JP, ES, NZ, AU, FR, AR, MX, IT, CL, TR, SA, MY, CH, IE, TH, SG, KW, BE, DE, PT, QA, MA, FI, AE, EG, BS, GB, BM, GR, BH, KR, MC, PL, LB, HK, IN, IL, MO, IQ, TN, NO, PH, CO, TW, CN, JO, OM.
The states and territories these words name
54 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
- Puerto Rico
- 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 Nov 14, 2024.
- FDA classified it on Dec 11, 2024.
- FDA’s Enforcement Report published it on Dec 18, 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.
- 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 886,930 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.