BD Pyxis MedBank System - Product Label/labeling pending
Medical device recall Z-0928-2023. Published in FDA’s Enforcement Report on Jan 18, 2023.
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 Jan 18, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 40 states named
- 6,796 systems 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 customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BD Pyxis MedBank System - Product Label/labeling pending
6,796 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
BD Pyxis” MedBank Tower Main UDI Code: 10885403512568 Catalog Numbers: 169-23 to 169-81, 169-100, 169-132, 169-138, 169-139 BD Pyxis” MedBank Mini Main UDI Code: 10885403512544 Catalog Numbers: 169-101 - 169-113, 169-137 BD Pyxis” MEDFLEX…
Every code shown here, 1,992 characters
BD Pyxis” MedBank Tower Main UDI Code: 10885403512568 Catalog Numbers: 169-23 to 169-81, 169-100, 169-132, 169-138, 169-139 BD Pyxis” MedBank Mini Main UDI Code: 10885403512544 Catalog Numbers: 169-101 - 169-113, 169-137 BD Pyxis” MEDFLEX BD Pyxis” MEDFLEX 2.0 UDI Codes:10885403512704 Catalog Numbers: 1119-00 1139-00 MedBank 200/500 UDI Code: N/A Catalog Numbers: 1137-00 BD Pyxis MEDPASS v1.0 or prior UDI Code: 10885403513817 Catalog Number: Not Provided BD Pyxis” MedBank Cabinet Software v2.2 or prior UDI Codes: 10885403513794 Catalog Number: N/A Affected Serial Numbers: 12940473 12971999 12972001 12972004 12972006 12972007 12982486 12982487 12982488 12982489 12982490 12982491 12982492 12982493 13517006 13523350 13598718 13629024 13727050 13739164 13754724 13766710 13766711 13767953 13769979 13770265 13770291 13789575 13792769 13801727 13802400 13817034 13819501 13826187 13829362 13829363 13829364 13832440 13843251 13849951 13853916 13853918 13856246 13873024 13875126 13875127 13877499 13877712 13877713 13877714 13877715 13879543 13879544 13880558 13883357 13884040 13884382 13884848 13884851 13885104 13885635 13889874 13889875 13889876 13889877 13896746 13905178 13908407 13909109 13909805 13909807 13909811 13909812 13920301 13920929 13921844 13922339 13922383 13923418 13923419 13923420 13926990 13929455 13929458 13931363 13931627 13933837 13934472 13939322 13939327 13939451 13941235 13941263 13943281 13944200 13944201 13945364 13945365 13945495 13945496 13945498 13946708 13947011 13947037 13947040 13947516 13947517 13947572 13947846 13948724 13949142 13950437 13954824 13956160 13961110 13961111 13961120 13963180 13963181 13963182 13964429 13965052 13966639 13973538 13977588 13985115 14005805 14006853 14007599 14008329 14011497 14011500 14017694 14032802 14036852 14037891 14045577 14054190 14054191 14062430 14075911 14083989 14085448 14087128 14095393 14095395 14101518 14101521 14101910 14101916 14112317 14112319 14112706 14112707 14125212 14128591 14133084…
FDA’s list runs to 61,743 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.
U.S. Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV.
The states and territories these words name
40 states and territories.
Every one of them
- Alaska
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Washington
- Wisconsin
- West Virginia
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.
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 Dec 12, 2022.
- FDA classified it on Jan 10, 2023.
- FDA’s Enforcement Report published it on Jan 18, 2023.
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 61,743 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.