BD Pyxis MedStation Auxiliary ES
Medical device recall Z-1123-2025. Published in FDA’s Enforcement Report on Feb 19, 2025.
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 Feb 19, 2025. Copied from openFDA on Oct 20, 2026.
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?
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 10885403512681/ Serial Numbers: 16183869 16183877 16181308 16181309 16184719 16184720 16155214 16167998 16173711 16173716 16173724 16173725 16173726 16173727 16173728 16156524 16156529 16163412 16163413 16163416 16163417 16163418…
Every code shown here, 1,999 characters
UDI: 10885403512681/ Serial Numbers: 16183869 16183877 16181308 16181309 16184719 16184720 16155214 16167998 16173711 16173716 16173724 16173725 16173726 16173727 16173728 16156524 16156529 16163412 16163413 16163416 16163417 16163418 16163420 16155945 16182183 16182295 16182298 16184712 16187332 16173521 16173523 16190551 16190552 16190553 16190554 16167592 16185663 16188550 16188551 16188560 16188561 16173437 16173439 16103949 16173522 16177055 16177056 16173680 16173681 16173714 16173717 16173718 16173719 16173721 16173722 16173723 16177910 16185638 16188602 16188603 16192625 16192634 16182181 16182185 16200812 16169401 16167449 16167996 16162741 16162739 16162742 16162743 16162744 16162745 16161320 16161322 16161324 16167522 16194353 16183841 16183843 16195336 16156521 16144089 16144090 16144095 16144096 16145983 16167581 16167583 16167585 16167587 16167589 16192307 16192309 16192622 16192627 16192631 16102579 16196727 16196729 16196626 16195229 16192630 16196649 16192240 16173615 16173616 16177914 16198683 16194363 16195232 16182179 16182180 16182182 16182292 16182296 16182297 16164498 16192308 16155092 16153374 16155093 16155086 16149567 16149568 16168891 16168893 16161075 16161077 16109954 16161082 16161083 16183881 16184147 16184177 16195332 16195334 16195338 16155966 16155967 16155968 16187307 16187312 16187314 16187318 16167351 16195841 16183868 16183879 16200806 16167457 16187702 16187716 16187718 16187720 16187722 16187725 16187732 16187736 16190308 16196664 16198551 16200827 16200828 16200831 16080977 16167445 16167446 16172514 16162529 16161071 16161073 16161076 16188224 16188225 16184150 16184162 16161349 16161350 16183849 16183850 16146702 16187738 16187739 16187742 16187743 16187744 16187745 16187746 16048532 16048533 16176335 16176336 16177014 16177020 16177021 16177026 16177041 16177042 16177043 16188975 16188978 16185612 16185613 16185616 16185619 16185620 16185622 16177830 16177833 16177835 16177836 16177837 16177842 16177844 16167650 16167340…
FDA’s list runs to 56,242 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.
US: Nationwide OUS:JP IT IN DE GB KR NL TW ES BE AU BH CA BR NZ FR AR QA MX CL TR SA MY CH IL IE TH SG KW MA FI AE EG BS BM GR MC PL LB MO IQ TN NO PH CN HK CO JO OM
These words name no state.
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 Feb 23, 2024.
- FDA classified it on Feb 11, 2025.
- FDA’s Enforcement Report published it on Feb 19, 2025.
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 56,242 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.