Hearth Record

BD Pyxis MedStation ES AUX Tower

Medical device recall Z-1050-2025. Published in FDA’s Enforcement Report on Feb 5, 2025.

FDA’s own record, on accessdata.fda.gov

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 5, 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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory discrepancies, a delay in access to medication and/or diversion of medication.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis “ MedStation 4000 AUX Tower REF 314 The BD Pyxis” MedStation ES and Pyxis” MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized healthcare provider.

Initial: 27,666 Expansion: 5,923 = 33,589 systems, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

BD Pyxis MedStation ES AUX Tower Catalog Number: 343 UDI-DI code: 10885403512698 Serial Number/Equipment Number: 14535900 14535900 14535901 14535901 14535902 14535902 14535903 14535903 14535904 14535904 14535905 14535905 14535906 14535906…

Every code shown here, 1,994 characters

BD Pyxis MedStation ES AUX Tower Catalog Number: 343 UDI-DI code: 10885403512698 Serial Number/Equipment Number: 14535900 14535900 14535901 14535901 14535902 14535902 14535903 14535903 14535904 14535904 14535905 14535905 14535906 14535906 14535907 14535907 14535908 14535908 14535910 14535910 14535912 14535912 14535913 14535913 14535916 14535916 14535919 14535919 14535922 14535922 14535924 14535924 14535926 14535926 14535928 14535928 14535930 14535930 14535932 14535932 14535934 14535934 14535936 14535936 14535937 14535937 14535939 14535939 14535941 14535941 14535943 14535943 14535945 14535945 14535947 14535947 14535949 14535949 14535951 14535951 14535953 14535953 14535954 14535954 14535956 14535956 14535958 14535958 14535960 14535960 14535962 14535962 14535964 14535964 14535966 14535966 14549572 14549572 14549573 14549573 14549574 14549574 14549575 14549575 14549576 14549576 14549577 14549577 14651270 14651270 14651271 14651271 14651282 14651282 14651297 14651297 14651298 14651298 14651299 14651299 14651314 14651314 14651315 14651315 14651316 14651316 14651317 14651317 14651357 14651357 14651358 14651358 14651359 14651359 14651390 14651390 14703129 14703129 14703130 14703130 14703131 14703131 14735444 14735444 14735445 14735445 14735446 14735446 14735447 14735447 14735448 14735448 14753109 14753109 14753111 14753111 14753112 14753112 14753126 14753126 14753127 14753127 14753128 14753128 14753129 14753129 14753130 14753130 14753131 14753131 14753132 14753132 14753145 14753145 14753146 14753146 14753147 14753147 14753148 14753148 14753149 14753149 14753150 14753150 14753167 14753167 14753177 14753177 14753182 14753182 14753184 14753184 14768245 14768245 14891921 14891921 14891922 14891922 14891923 14891923 14891924 14891924 14916994 14916994 14916995 14916995 14916996 14916996 14916997 14916997 14916998 14916998 14916999 14916999 14917000 14917000 14917001 14917001 14917002 14917002 14917003 14917003 14917004 14917004 14917005 14917005 14917006 14917006 14917007…

FDA’s list runs to 1,095,129 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

U.S.: 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Germany and Japan

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

The words say it went outside the United States too.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Feb 14, 2023.
  • FDA classified it on Jan 30, 2025.
  • FDA’s Enforcement Report published it on Feb 5, 2025.
Source:

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.
Source:

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 1,095,129 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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