BD Pyxis MedStation ES
Medical device recall Z-1927-2024. Published in FDA’s Enforcement Report on Jun 5, 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 Jun 5, 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 53 states named
- 212,367 units 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?
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BD Pyxis MedStation ES, REF: 323, Medication Cabinet
212,367 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 10885403512667/New Serial Numbers reported 8/27/25: 14879021 15683381 15683382 15683385 15683386 15683387 15683388 15683389 15683390 15674988 15674992 15674993 15674994 15674995 15674996 15674998 15674999 15675000 15675001 15675036…
Every code shown here, 1,992 characters
UDI: 10885403512667/New Serial Numbers reported 8/27/25: 14879021 15683381 15683382 15683385 15683386 15683387 15683388 15683389 15683390 15674988 15674992 15674993 15674994 15674995 15674996 15674998 15674999 15675000 15675001 15675036 15758077 15758078 15758079 15755497 15755499 15755501 15754424 17269762 13625680 13625681 13625682 13625684 13611196 13611198 13611204 13467008 13336011 13336013 13336014 13336015 13336016 14386862 14265629 14265630 14202688 14202689 14202690 14202691 14202692 14194839 14194841 14194842 14157202 14157203 14157204 14157205 14157206 14157207 14157208 14157209 14157210 14157211 14157212 13785825 13593077 13192143 13137112 13074966 13074968 13055699 13055700 13055726 13054792 13054060 13054061 13054101 12698939 17332556 17122344 16995995 16995997 16995998 16996016 16747803 16747804 16747805 16747843 16747844 16747988 15616385 15664565 15607464 15607465 15607466 15607495 15607497 15607498 15607499 15607501 15607503 15604320 15604321 15604323 15604324 15604326 15604327 15604328 15604329 15604330 15604331 15604332 15604333 15604334 15604336 15604363 15581091 17338599 17338602 16721620 16721621 16721623 16721625 16721627 15284381 15284382 15222320 15174016 15174029 15174030 14895248 14852791 14666440 14665877 14653429 14653430 14649023 14649024 14649026 14649027 14648431 14648432 14648433 14639938 14639940 14639160 14639162 14639315 14639316 14634709 14634710 14632403 14630545 14629441 14629442 14619333 14617921 14617922 14617923 14617926 14617927 14618342 14604018 14592478 14592479 14592480 14592481 14592482 14592483 14543160 14543161 14543162 14543163 14543164 14543166 14543167 14541637 14541639 14541658 14541661 14541663 14541664 14539223 14537571 14537572 14537573 14537574 14537578 14537579 14537580 14537583 14537589 14537590 14529072 14529073 14518470 14518471 14518475 14518480 14486061 14522390 14522391 14522392 14522393 14522397 14522398 14522399 14522401 14522402 14522403 14522405 14522406 14522407 14522409 14522410 14522416…
FDA’s list runs to 1,919,449 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 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of South Africa, Kuwait, Qatar, Singapore, Bermuda, United Arab Emirates, Argentina, Australia, Belgium, Bahrain, Brazil, Bahamas, Canada, Chile, China, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Italy, Japan, South Korea, Lebanon, Morocco, Mexico, New Zealand, Oman, Portugal, Thailand, Taiwan.
The states and territories these words name
53 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
- 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 Apr 15, 2024.
- FDA classified it on May 30, 2024.
- FDA’s Enforcement Report published it on Jun 5, 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.
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 1,919,449 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.