BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow
Medical device recall Z-2487-2024. Published in FDA’s Enforcement Report on Aug 14, 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 Aug 14, 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 41 states named
- 61 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?
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
61 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 10885403512568/ Serial Number: 16139674 16124908 16063924 16084467 16221549 16139675 16220875 16237258 16284001 15940400 15940104 15941703 15941654 15943750 15943749 15500696 15654711 15654721 15631099 15631104 15775749 15383480…
Every code shown here, 584 characters
UDI: 10885403512568/ Serial Number: 16139674 16124908 16063924 16084467 16221549 16139675 16220875 16237258 16284001 15940400 15940104 15941703 15941654 15943750 15943749 15500696 15654711 15654721 15631099 15631104 15775749 15383480 15383481 15383475 15383486 15383487 15366328 15606170 15575974 15575976 15490745 15422133 15853047 15902413 15598095 15550853 15437809 15437812 15518269 15518273 15518270 15872432 15872429 15662816 15504833 15504836 15503511 15430948 15430963 15639687 15639724 15639720 15639718 15328493 15442794 15442789 15761398 15761401 15937579 15786154 15684803
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 distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV.
The states and territories these words name
41 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- 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 Jun 24, 2024.
- FDA classified it on Aug 2, 2024.
- FDA’s Enforcement Report published it on Aug 14, 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.
- 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.”
- 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.