139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS…
Medical device recall Z-1229-2025. Published in FDA’s Enforcement Report on Mar 5, 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 Mar 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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFLEX MN 1000 4HH-1FM 139049-01 BD PYXIS MEDFLEX MN 1000 4HH-4FM 139044-01 BD PYXIS MEDFLEX MN 1000 6FM 139039-01 BD PYXIS MEDFLEX MN 1000 6HH 139051-01 BD PYXIS MEDFLEX MN 1000 6HH-3FM 139164-01 BD PYXIS MEDFLEX MN 1000 8HH-2FH 139052-01 BD PYXIS MEDFLEX MN 1000 8HH-2FM 139070-01 BD PYXIS MEDFLEX MN 2000 10HH-1FM 139071-01 BD PYXIS MEDFLEX MN 2000 12HH 139061-01 BD PYXIS MEDFLEX MN 2000 2HH-2FM 139066-01 BD PYXIS MEDFLEX MN 2000 2HH-3FM-1DD 139065-01 BD PYXIS MEDFLEX MN 2000 2HH-5FM 139058-01 BD PYXIS MEDFLEX MN 2000 3FM 139060-01 BD PYXIS MEDFLEX MN 2000 4HH-1FM 139067-01 BD PYXIS MEDFLEX MN 2000 4HH-4FM 139064-01 BD PYXIS MEDFLEX MN 2000 6FM 139059-01 BD PYXIS MEDFLEX MN 2000 6HH 139068-01 BD PYXIS MEDFLEX MN 2000 6HH-3FM 139165-01 BD PYXIS MEDFLEX MN 2000 8HH-2FH 139069-01 BD PYXIS MEDFLEX MN 2000 8HH-2FM 1139-00 MEDFLEX 2.0 1119-00 MEDFLEX
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
MEDFLEX 1119-00 10885403512704 MEDFLEX 2.0 1139-00 10885403512704 MEDBANK TOWER MAIN 1145-00 10885403517167 MEDBANK MINI MAIN 1147-00 10885403517181 BD PYXIS MEDBANK MINI 2FH 138902-01 N/A BD PYXIS MEDBANK MINI 2FM 138903-01 N/A BD Pyxis…
Every code shown here, 1,989 characters
MEDFLEX 1119-00 10885403512704 MEDFLEX 2.0 1139-00 10885403512704 MEDBANK TOWER MAIN 1145-00 10885403517167 MEDBANK MINI MAIN 1147-00 10885403517181 BD PYXIS MEDBANK MINI 2FH 138902-01 N/A BD PYXIS MEDBANK MINI 2FM 138903-01 N/A BD Pyxis MedBank Twr Mn 4HH-8HM-1FM 138905-01 N/A BD PYXIS MEDBANK MINI 2HH-1FM 138906-01 N/A BD PYXIS MEDBANK MINI 2HH-2HM 138907-01 N/A BD PYXIS MEDBANK MINI 2HH-1FH 138908-01 N/A BD PYXIS MEDBANK MINI 3HH-1HM 138909-01 N/A BD PYXIS MEDBANK MINI 4HH 138910-01 N/A BD PYXIS MEDBANK MINI CR-4HH-P 138911-01 N/A BD PYXIS MEDBANK MINI 1HH-3HM 138912-01 N/A BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138913-01 N/A BD Pyxis MedBank Twr Mn 5HH-9HM 138914-01 N/A BD PYXIS MEDBANK MINI 4HM 138915-01 N/A BD PYXIS MEDBANK TWR MN 4HM-5FM 138916-01 N/A BD PYXIS MEDBANK TWR MN 4HH-5FH 138917-01 N/A BD PYXIS MEDBANK TWR MN 4HH-5FM 138918-01 N/A BD PYXIS MEDBANK TWR MN 2HH-6FM 138919-01 N/A BD PYXIS MEDBANK TWR MN 7FH 138920-01 N/A BD PYXIS MEDBANK MINI 1HH-1FH-1HM 138921-01 N/A BD PYXIS MEDBANK TWR MN 6HH-4FM 138922-01 N/A BD PYXIS MEDBANK TWR MN 8HH-3FM 138923-01 N/A BD PYXIS MEDBANK TWR MN 10HH-2FM 138924-01 N/A BD PYXIS MEDBANK TWR MN 12HH-1FM 138926-01 N/A BD PYXIS MEDBANK TWR MN 14HH 138927-01 N/A BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM 138929-01 N/A BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM 138930-01 N/A BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM 138931-01 N/A BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM 138932-01 N/A BD PYXIS MEDBANK TWR MN 3FH-4FM 138933-01 N/A BD PYXIS MEDBANK TWR MN 4HH-1FH-4FM 138934-01 N/A BD PYXIS MEDBANK TWR MN 6HH-1FH-3FM 138936-01 N/A BD PYXIS MEDBANK TWR MN 7FM 138937-01 N/A BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF 138938-01 N/A BD PYXIS MEDBANK TWR MN 8HH-2HM-2FM 138939-01 N/A BD PYXIS MEDBANK TWR MN 4HH-4FH-1FM 138940-01 N/A BD PYXIS MEDBANK TWR MN 4HH-6HM-2FM 138941-01 N/A BD PYXIS MEDBANK TWR MN 8HH-1FH-2FM 138942-01 N/A BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM 138943-01 N/A BD PYXIS MEDBANK TWR MN 6HH-2FH-2HM-1FM 138944-01 N/A BD PYXIS MEDBANK TWR MN…
FDA’s list runs to 18,021 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 distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
The states and territories these words name
48 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- 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.
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 Jan 8, 2025.
- FDA classified it on Feb 21, 2025.
- FDA’s Enforcement Report published it on Mar 5, 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 18,021 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.