BD Pyxis CII Safe ES
Medical device recall Z-0672-2025. 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
- 218 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 CII Safe ES, REF: 1116-00
218, 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: 1116-00/10885403512605/ 15938609 15938608 15960426 15977244 15977243 15997587 15997584 15997586 16001276 16004167 16004170 16004168 16006959 16016028 16018286 16018285 16027068 16034363 16038606 16038608…
Every code shown here, 1,994 characters
All software versions. REF/UDI-DI: 1116-00/10885403512605/ 15938609 15938608 15960426 15977244 15977243 15997587 15997584 15997586 16001276 16004167 16004170 16004168 16006959 16016028 16018286 16018285 16027068 16034363 16038606 16038608 16042040 16043100 16051041 16052300 16056892 16081629 16089006 16107354 16121844 16124176 16124177 16124175 16124174 16124178 16142019 16142717 16147368 16150604 16150317 16154380 16154381 16179910 16185906 16186402 16186403 16188916 16188917 16189876 16191858 16191855 16192478 16192476 16198735 16205805 16205708 16210899 16211121 16211303 16211474 16216310 16216322 16216171 16216317 16216324 16216170 16217014 16217009 16217010 16217006 16222804 16229923 16234971 16234972 16234970 16234973 16234969 16235009 16236311 16238237 16238264 16239968 16247326 16253283 16262739 16267647 16273818 16273822 16277384 16280705 16282121 16282137 16282082 16283296 16287656 16291326 16292340 16294019 16295348 16295346 16297236 16297224 16299107 16300479 16309949 16315507 16317206 16317204 16317205 16317207 16319700 16319670 16322458 16322446 16323719 16327551 16335942 16337405 16338265 16338264 16344600 16344608 16349184 16349205 16354606 16380050 16381506 16381558 16411952 16411951 16412194 16413752 16413747 16415153 16415200 16415590 16416557 16416531 16418522 16418188 16418187 16418507 16423221 16425773 16426437 16433986 16444194 16445004 16444237 16445017 16460539 16461440 16460710 16460551 16468172 16468090 16468208 16468173 16468174 16469932 16474654 16479163 16484107 16487985 16490699 16507895 16507875 16529195 16538278 16550545 16554103 16554102 16554100 16554079 16582605 16585680 16585665 16585669 16585576 16585655 16595099 16595093 16601179 16627555 16626472 16627561 16626460 16630815 16641357 16664753 16672435 16685055 16685063 16706784 16706834 16712895 16719658 16719611 16719695 16755235 16755194 16764093 16767178 16769446 16773194 16785716 16785719 16790736 16808348 16808370 16808330 16811697 16826563 16832646 16832644 16832647…
FDA’s list runs to 2,020 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 2,020 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.