BD Pyxis MedStation ES (Med ES Main)
Medical device recall Z-1122-2025. 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 ES (Med ES Main) REF: 323. 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: 0885403212667/Serial Numbers: 16160944 16142237 16188205 16188207 16188212 16188216 16188220 16188229 16130230 16130231 16183872 16184152 16180604 16155071 16172476 16161355 16184716 16184717 16155208 16155209 16155210 16155211…
Every code shown here, 1,997 characters
UDI: 0885403212667/Serial Numbers: 16160944 16142237 16188205 16188207 16188212 16188216 16188220 16188229 16130230 16130231 16183872 16184152 16180604 16155071 16172476 16161355 16184716 16184717 16155208 16155209 16155210 16155211 16155212 16155213 16156000 16156004 16156006 16156008 16156018 16145933 16180546 16180547 16180548 16161088 16183862 16173683 16173684 16173685 16173686 16173687 16173696 16173698 16173701 16173702 16173703 16168000 16173704 16173705 16164513 16164517 16155941 16155943 16167578 15925963 16145929 16145930 16130236 16145931 16145932 16183776 16183781 16183784 16183789 16183792 16183801 16183804 16161294 16184711 16184713 16187331 16190475 16161087 16173513 16173514 16173515 16179685 16173518 16179683 16173529 16179596 16168002 16177915 16188887 16177921 16190561 16185661 16185662 16188555 16188556 16188557 16188558 16188559 16188562 16188564 16188565 16188566 16188567 16188568 16188569 16188570 16188571 16173435 16173436 16173438 16173440 16160946 16161016 16161060 16161065 16183829 16183830 16183832 16183833 16183835 16183836 16183837 16183848 16173517 16173679 16173682 16173690 16173692 16173693 16173694 16173695 16173697 16173699 16173700 16173706 16173709 16173713 16177907 16177908 16177909 16194589 16164428 16185637 16185639 16185640 16195920 16188597 16188598 16188599 16192623 16192624 16192632 16192633 16192635 16155435 16182337 16183778 16183782 16183791 16183797 16183798 16195917 16195918 16186373 16186375 16186376 16167488 16167489 16167490 16155336 16168907 16188870 16188878 16188879 16188885 16188888 16188889 16188890 16188904 16172996 16172997 16190471 16162843 16162844 16162845 16162796 16162797 16162798 16163232 16162799 16193839 16155217 16155218 16155220 16155222 16155224 16155225 16145934 16161406 16161384 16161387 16161388 16161389 16161390 16161395 16161397 16161398 16161336 16161337 16161321 16161323 16162753 16162754 16162756 16162761 16162762 16162768 16162726 16195804 16188871 16188872 16188873 16188874 16188875…
FDA’s list runs to 128,386 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 128,386 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.