Z-1552-2025Class II

MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF...

Name: Z-1552-2025 MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF...
Creator: CareFusion 303, Inc.
Published: 2023-10-05
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2023-10-05 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS... on 2023-10-05. FDA classified it as Class II and gives the reason as "If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1552-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-05
Posted: 2025-04-11
Recalling firm: CareFusion 303, Inc
Product: MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1FH- 1HM, REF: 169-101; BD PYXIS MEDBANK MINI 1HH-1HM- 1FM, REF: 169-102; BD PYXIS MEDBANK MINI 1HH-3HM, REF: 169-103; BD PYXIS MEDBANK MINI 2FH, REF: 169-104; BD PYXIS MEDBANK MINI 2FM, REF: 169-105; BD PYXIS MEDBANK MINI 2HH-1FH, REF: 169-106; BD PYXIS MEDBANK MINI 2HH-1FM , REF: 169-107; BD PYXIS MEDBANK MINI 2HH-2HM, REF: 169-108; BD PYXIS MEDBANK MINI 2HM-1FM, REF: 169-109; BD PYXIS MEDBANK MINI 3HH-1FG, REF: 169-110; BD PYXIS MEDBANK MINI 3HH-1HM, REF: 169-111; BD PYXIS MEDBANK MINI 4HH, REF: 169-112; BD PYXIS MEDBANK MINI 4HM, REF: 169-113; BD PYXIS MDBANK TWR MN 7HH-1HM-3FM RxNow, REF: 169-132; BD PYXIS MEDBANK MINI 1FH-1FM, REF: 169-137; BD PYXIS MEDBANK TWR MN 1FH- 10HM-1FM, REF: 169-138; BD PYXIS MEDBANK TWR MN 2HH- 4FH-2FM, REF: 169-139; OBS BD PYXIS MB TOWER MAIN, REF: 169-153; OBS BD PYXIS MB TWR RXNOW MAIN W/MED PRI, REF: 169-155; OBS BD PYXIS MB TWR RXNOW MAIN W/PAT PRI, REF: 169-156; OBS BD PYXIS MB MINI MAIN W/CUBIE DRWS, REF: 169-159; OBS BD PYXIS MB MINI MAIN W/MATRIX DRWS, REF: 169-160; OBS BD PYXIS MB MINI MAIN W/HH FALSE DRW, REF: 169-161; OBS BD PYXIS MB MINI MAIN W/FH FALSE DRW, REF: 169-162; BD PYXIS MEDBANK TWR MN 10HH- 1FH-1FM, REF: 169-23; BD PYXIS MEDBANK TWR MN 10HH- 2FH, REF: 169-24; BD PYXIS MEDBANK TWR MN 10HH- 2FM, REF: 169-25; BD PYXIS MEDBANK TWR MN 12HH- 1FF, REF: 169-26; BD PYXIS MEDBANK TWR MN 12HH- 1FH, REF: 169-27; BD PYXIS MEDBANK TWR MN 12HH- 1FM, REF: 169-28; BD PYXIS MEDBANK TWR MN 14HH, REF: 169-29; BD PYXIS MEDBANK TWR MN 1HH- 1HM-2FM-4FF, REF: 169-30; BD PYXIS MEDBANK TWR MN 2FH- 2HM-4FM, REF: 169-31; BD PYXIS MEDBANK TWR MN 2HH- 10HM-1FM, REF: 169-32; BD PYXIS MEDBANK TWR MN 2HH- 1FH-5FM, REF: 169-33; BD PYXIS MEDBANK TWR MN 2HH- 2FH-4FM, REF: 169-34; BD PYXIS MEDBANK TWR MN 2HH- 2FM-4FF, REF: 169-35; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FF, REF: 169-36; BD PYXIS MEDBANK TWR MN 2HH- 4HM-4FM, REF: 169-37; BD PYXIS MEDBANK TWR MN 2HH- 6FM, REF: 169-38; BD PYXIS MEDBANK TWR MN 2HH- 6HM-3FM, REF: 169-39; BD PYXIS MEDBANK TWR MN 2HH- 8HM-2FM, REF: 169-40; BD PYXIS MEDBANK TWR MN 2HM- 6FM, REF: 169-41; BD PYXIS MEDBANK TWR MN 3FH-4FM , REF: 169-42; BD PYXIS MEDBANK TWR MN 3HH- 7HM-2FM, REF: 169-43; BD PYXIS MEDBANK TWR MN 4HH- 10HM, REF: 169-44; BD PYXIS MEDBANK TWR MN 4HH- 1FH-2HM-3FM, REF: 169-45; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4FM, REF: 169-46; BD PYXIS MEDBANK TWR MN 4HH- 1FH-4HM-2FM, REF: 169-47; BD PYXIS MEDBANK TWR MN 4HH- 1FH-6HM-1FM, REF: 169-48; BD PYXIS MEDBANK TWR MN 4HH- 2FH-2HM-2FM, REF: 169-49; BD PYXIS MEDBANK TWR MN 4HH- 2FH-3FM, REF: 169-50; BD PYXIS MEDBANK TWR MN 4HH- 2HM-4FM, REF: 169-51; BD PYXIS MEDBANK TWR MN 4HH- 3FH-2FM, REF: 169-52; BD PYXIS MEDBANK TWR MN 4HH- 4FH-1FM, REF: 169-53; BD PYXIS MEDBANK TWR MN 4HH- 4HM-3FM, REF: 169-54; BD PYXIS MEDBANK TWR MN 4HH-5FH, REF: 169-55; BD PYXIS MEDBANK TWR MN 4HH- 5FM, REF: 169-56; BD PYXIS MEDBANK TWR MN 4HH- 6HM-2FM, REF: 169-57; BD PYXIS MEDBANK TWR MN 4HH- 8HM-1FM, REF: 169-58; BD PYXIS MEDBANK TWR MN 4HM- 5FM, REF: 169-59; BD PYXIS MEDBANK TWR MN 5HH- 3HM-3FM, REF: 169-60; BD PYXIS MEDBANK TWR MN 5HH- 9HM, REF: 169-61; BD PYXIS MEDBANK TWR MN 6FH-1FM, REF: 169-62; BD PYXIS MEDBANK TWR MN 6HH- 1FH-2HM-2FM, REF: 169-63; BD PYXIS MEDBANK TWR MN 6HH- 1FH-3FM, REF: 169-64; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2FM, REF: 169-65; BD PYXIS MEDBANK TWR MN 6HH- 2FH-2HM-1FM, REF: 169-66; BD PYXIS MEDBANK TWR MN 6HH-4FH, REF: 169-67; BD PYXIS MEDBANK TWR MN 6HH- 4FM, REF: 169-68; BD PYXIS MEDBANK TWR MN 6HH- 4HM-2FM, REF: 169-69; BD PYXIS MEDBANK TWR MN 6HH- 6HM-1FM, REF: 169-70; BD PYXIS MEDBANK TWR MN 6HH- 8HM, REF: 169-71; BD PYXIS MEDBANK TWR MN 7FH, REF: 169-72; BD PYXIS M
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal.
Root cause tag: software
FDA root cause: Software design
Action: 05OCT2023, Customer Release Notes were sent to customers informing them of system release v1.3.4. On 2/18/2025, correction notices were mailed and emailed to Customers, Directors of Pharmacy, and Facility Medication Management Administrators who were informed the following: 1) Customers with system administrator privileges can uncheck the option for the "Clear All" button in the BD Pyxis MedBank Facility Software, which will disable the feature and prevent the button from displaying on the patient profile selection screen. 2) Best practice is to verify the item being removed is accurate against the provider s order, and if available utilize barcode medication administration as an additional check to ensure the correct medication is retrieved prior to administration.1 3) Share and disseminate this notice within your facility network to ensure they are aware of the field action. 4) Complete and return the Customer Response Form via email to [email protected] BD Pyxis MedBank Facility Software version 2.5.1.4 within MedBank system release v1.7 is currently available and will address this issue. BD will contact impacted customers to schedule a time for software upgrade. If you have questions contact the firm's Technical Support at 1-866-930-9251 Phone Hours: 24 hours, 7 days a week.
Quantity in commerce: 2679
Distribution: US Nationwide distribution in the states of KS, TX, CA, PA, NJ, FL, IN, AZ, IL, MA, NY, KY, UT, MD, WA, OH, AL.
Product codes and lots: BD Pyxis MedBank Receiving Cabinet Software Software versions: 2.1.2.11, 2.2.1.8, 2.31.8, 2.3.2.1, 2.4.2.26 REF/UDI-DI: 1119-00/10885403512704; 1137-00; 1139-00/10885403512704; 1145-00/10885403517167; 1147-00/10885403517181; 139090-01; 169-100/10885403512568; 169-101/10885403512544; 169-102/10885403512544; 169-103/10885403512544; 169-104/10885403512544; 169-105/10885403512544; 169-106/10885403512544; 169-107/10885403512544; 169-108/10885403512544; 169-109/10885403512544; 169-110/10885403512544; 169-111/10885403512544; 169-112/10885403512544; 169-113/10885403512544; 169-132/10885403512568; 169-137/10885403512544; 169-138/10885403512568; 169-139/10885403512568; 169-153/10885403512568; 169-155/10885403512568; 169-156/10885403512568; 169-159/10885403512544; 169-160/10885403512544; 169-161/10885403512544; 169-162/10885403512544; 169-23/10885403512568; 169-24/10885403512568; 169-25/10885403512568; 169-26/10885403512568; 169-27/10885403512568; 169-28/10885403512568; 169-29/10885403512568; 169-30/10885403512568; 169-31/10885403512568; 169-32/10885403512568; 169-33/10885403512568; 169-34/10885403512568; 169-35/10885403512568; 169-36/10885403512568; 169-37/10885403512568; 169-38/10885403512568; 169-39/10885403512568; 169-40/10885403512568; 169-41/10885403512568; 169-42/10885403512568; 169-43/10885403512568; 169-44/10885403512568; 169-45/10885403512568; 169-46/10885403512568; 169-47/10885403512568; 169-48/10885403512568; 169-49/10885403512568; 169-50/10885403512568; 169-51/10885403512568; 169-52/10885403512568; 169-53/10885403512568; 169-54/10885403512568; 169-55/10885403512568; 169-56/10885403512568; 169-57/10885403512568; 169-58/10885403512568; 169-59/10885403512568; 169-60/10885403512568; 169-61/10885403512568; 169-62/10885403512568; 169-63/10885403512568; 169-64/10885403512568; 169-65/10885403512568; 169-66/10885403512568; 169-67/10885403512568; 169-68/10885403512568; 169-69/10885403512568; 169-70/10885403512568; 169-71/10885403512568; 169-72/10885403512568; 169-73/10885403512568; 169-74/10885403512568; 169-75/10885403512568; 169-76/10885403512568; 169-77/10885403512568; 169-78/10885403512568; 169-79/10885403512568; 169-80/10885403512568; 169-81/10885403512568; 139089-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1552-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1552-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-23	2025-04-11

Product code BRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)