Z-1545-2025Class II

BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are...

Name: Z-1545-2025 BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are...
Creator: CareFusion 303, Inc.
Published: 2025-03-11
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-03-11 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to... on 2025-03-11. FDA classified it as Class II and gives the reason as "Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the...". 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-1545-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-11
Posted: 2025-04-09
Recalling firm: CareFusion 303, Inc
Product: BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.
Root cause tag: software
FDA root cause: Software design
Action: On 3/11/2025, "URGENT MEDICAL DEVICE CORRECTION" notices were mailed and emailed to Medical Director, Risk Manager, Medical Device Safety Officer, Lab Manager, Clinical Engineering, and other customers asking them to take the following actions: 1) Best practice is to verify the total dose being removed is accurate against the provider's order, and if available utilize barcode medication administration as an additional check to ensure the correct dose is retrieved prior to administration. 2) Customers can inventory the CUBIE pocket via a cycle count or blind count to correct the inventory when discrepancies occur. Customers can refer to the BD Pyxis MedBank Cabinet User Guide - 10000414987 Ver. 01, Version v2.4 for instructions. Refer to chapter six (6), page 103. 3)Customers should ensure backup procedures (which may include but are not limited to keys, emergency medication supplies, alternate devices in proximity, etc) are in place and staff have all been properly educated on them. 4) Share this letter with any facilities within your network that you may have distributed affected devices to. 5) Post this Recall Letter on or near affected products as a reminder of the recall and the steps/instructions that are needed to be followed. 6) Complete and return the Response Form via email to [email protected] Firm is in the process of contacting all customers to schedule an appropriate time for the software upgrade to MedBank software version 1.7. If you require further assistance, contact the firm's technical support: 1-866-930-9251 Phone Hours: 24 hours, 7 days a week Website: https://bdx.my.site.com/CC360/s/impactedproducts?rn=MMS-24-5163/MMS-25-5183/5184
Quantity in commerce: 7357
Distribution: US Nationwide distribution: CA, TX, WI, CO, AK, VA, TN, WA, NC, NY, MS, FL, KS, MI, IN, MN, MT, KY, MO, UT, NJ, OH, PA, ND, OR, NE, SD, NV, OK, GA, MA, IA, HI, ME, AZ, IL, SC, LA, WV, AL, ID, NM, DC, NH, VT, CT, MD, AR, WY.
Product codes and lots: REF/UDI-DI(GTIN)/Software Version: 169-143/10885403512568/2.4; 169-145/10885403512568/2.4; 169-144/10885403512568/2.4; 169-142/10885403512568/2.4; 139088-01/1.2.3.23; 155288-01/10885403508721/2.4; 169-137/10885403512544/2.4; 155311-01/10885403510847/2.4; 169-151/10885403512544/1.2.3.23; 138921-01/2.4; 155159-01/10885403504655/2.4; 169-101/10885403512544/2.4; 139122-01/2.4; 155160-01/10885403504662/2.4; 169-102/10885403512544/2.4; 138912-01/2.4; 155161-01/10885403504679/2.4; 169-103/10885403512544/2.4; 138902-01/2.4; 169-104/10885403512544/2.4; 138903-01/2.4; 155163-01/10885403504686/2.4; 169-105/10885403512544/2.4; 138908-01/2.4; 169-106/10885403512544/2.4; 138906-01/2.4; 155165-01/10885403504693/2.4; 169-107/10885403512544/2.4; 169-152/10885403512544/1.2.3.23; 138907-01/2.4; 155166-01/10885403504570/2.4; 169-108/10885403512544/2.4; 139131-01/2.4; 155167-01/10885403504587/2.4; 169-109/10885403512544/2.4; 139091-01/2.4; 155168-01/10885403504594/2.4; 169-110/10885403512544/2.4; 138909-01/2.4; 155169-01/10885403504600/2.4; 169-111/10885403512544/2.4; 138910-01/2.4; 155310-01/10885403510830/2.4; 169-112/10885403512544/2.4; 169-150/10885403512544/1.2.3.23; 138915-01/2.4; 155171-01/10885403504617/2.4; 169-113/10885403512544/2.4; 138943-01/2.4; 155081-01/10885403503870/2.4; 169-23/10885403512568/2.4; 138955-01/2.4; 155082-01/10885403503887/2.4; 169-24/10885403512568/2.4; 138924-01/2.4; 155083-01/10885403503894/2.4; 169-25/10885403512568/2.4; 138960-01/2.4; 155084-01/10885403503900/2.4; 169-26/10885403512568/2.4; 138961-01/2.4; 155085-01/10885403503917/2.4; 169-27/10885403512568/2.4; 138926-01/2.4; 155086-01/10885403503726/2.4; 169-28/10885403512568/2.4; 138927-01/2.4; 155087-01/10885403503733/2.4; 169-29/10885403512568/2.4; 155293-01/10885403509926/2.4; 169-138/10885403512568/2.4; 155303-01/10885403510779/2.4; 139082-01/2.4; 155088-01/10885403503740/2.4; 169-30/10885403512568/2.4; 155305-01/10885403510793/2.4; 139056-01/2.4; 155089-01/10885403503757/2.4; 169-31/10885403512568/2.4; 155304-01/10885403510786/2.4; 139045-01/2.4; 155090-01/10885403503764/2.4; 169-32/10885403512568/2.4; 138932-01/2.4; 155091-01/10885403503771/2.4; 169-33/10885403512568/2.4; 139084-01/2.4; 155092-01/10885403503788/2.4; 169-34/10885403512568/2.4; 138963-01/2.4; 155093-01/10885403503795/2.4; 169-35/10885403512568/2.4; 155294-01/10885403509933/2.4; 169-139/10885403512568/2.4; 138938-01/2.4; 155094-01/10885403503801/2.4; 169-36/10885403512568/2.4; 139125-01/2.4; 155095-01/10885403503818/2.4; 169-37/10885403512568/2.4; 138919-01/2.4; 155096-01/10885403503696/2.4; 169-38/10885403512568/2.4; 139126-01/2.4; 155097-01/10885403504198/2.4; 169-39/10885403512568/2.4; 139127-01/2.4; 155098-01/10885403503702/2.4; 169-40/10885403512568/2.4; 139043-01/2.4; 155099-01/10885403504204/2.4; 169-41/10885403512568/2.4; 138933-01/2.4; 155100-01/10885403504211/2.4; 169-42/10885403512568/2.4; 155299-01/10885403510526/2.4; 169-140/10885403512568/1.2.3.23; 139142-01/2.4; 155101-01/10885403504228/2.4; 169-43/10885403512568/2.4; 155302-01/10885403510762/2.4; 138959-01/2.4; 155102-01/10885403504235/2.4; 169-44/10885403512568/2.4; 138954-01/2.4; 155103-01/10885403504242/2.4; 169-45/10885403512568/2.4; 138934-01/2.4; 155104-01/10885403504259/2.4; 169-46/10885403512568/2.4; 138950-01/2.4; 155105-01/10885403503719/2.4; 169-47/10885403512568/2.4; 138947-01/2.4; 155106-01/10885403504266/2.4; 169-48/10885403512568/2.4; 138945-01/2.4; 155107-01/10885403504273/2.4; 169-49/10885403512568/2.4; 138931-01/2.4; 155108-01/10885403504280/2.4; 169-50/10885403512568/2.4; 138929-01/2.4; 155109-01/10885403504327/2.4; 169-51/10885403512568/2.4; 138946-01/2.4; 155110-01/10885403504297/2.4; 169-52/10885403512568/2.4; 138940-01/2.4; 155111-01/10885403504303/2.4; 169-53/10885403512568/2.4; 138952-01/2.4; 155112-01/10885403504099/2.4; 169-54/10885403512568/2.4; 138917-01/2.4; 155113-01/10885403504105/2.4; 169-55/10885403512568/2.4; 138918-01/2.4; 155114-01/10885403504112/2.4; 169-56/10885403512568/2.4; 138941-01/2.4; 155115-01/10885403504129/2.4; 169-57/10885403512568/2.4; 138905-01/2.4; 155116-01/10885403504136/2.4; 169-58/10885403512568/2.4; 138916-01/2.4; 155117-01/10885403504143/2.4; 169-59/10885403512568/2.4; 139141-01/2.4; 155118-01/10885403504150/2.4; 169-60/10885403512568/2.4; 138914-01/2.4; 155119-01/10885403504334/2.4; 169-61/10885403512568/2.4; 139063-01/2.4; 155120-01/10885403504167/2.4; 169-62/10885403512568/2.4; 138953-01/2.4; 155121-01/10885403504174/2.4; 169-63/10885403512568/2.4; 138936-01/2.4; 155122-01/10885403504181/2.4; 169-64/10885403512568/2.4; 138962-01/2.4; 155123-01/10885403504082/2.4; 169-65/10885403512568/2.4; 138944-01/2.4; 155124-01/10885403504075/2.4; 169-66/10885403512568/2.4; 138957-01/2.4; 155125-01/10885403503658/2.4; 169-67/10885403512568/2.4; 138922-01/2.4; 155126-01/10885403503665/2.4; 169-68/10885403512568/2.4; 138930-01/2.4; 155127-01/10885403503672/2.4; 169-69/10885403512568/2.4; 139128-01/2.4; 155128-01/10885403503689/2.4; 169-70/10885403512568/2.4; 138958-01/2.4; 155129-01/10885403504341/2.4; 169-71/10885403512568/2.4; 138920-01/2.4; 155130-01/10885403504358/2.4; 169-72/10885403512568/2.4; 138937-01/2.4; 155131-01/10885403504365/2.4; 169-73/10885403512568/2.4; 139086-01/2.4; 155132-01/10885403504372/2.4; 169-74/10885403512568/2.4; 138942-01/2.4; 155133-01/10885403503542/2.4; 169-75/10885403512568/2.4; 138949-01/2.4; 155134-01/10885403503559/2.4; 169-76/10885403512568/2.4; 139062-01/2.4; 155135-01/10885403503566/2.4; 169-77/10885403512568/2.4; 138939-01/2.4; 155136-01/10885403503573/2.4; 169-78/10885403512568/2.4; 138948-01/2.4; 155137-01/10885403503597/2.4; 169-79/10885403512568/2.4; 138956-01/2.4; 155138-01/10885403503603/2.4; 169-80/10885403512568/2.4; 138923-01/2.4; 155139-01/10885403503610/2.4; 169-81/10885403512568/2.4; 139163-01/2.4. 1119-00/10885403512704/2.4; 1139-00/10885403512704/2.4. 139054-01/2.4; 139055-01/2.4; 139053-01/2.4; 139041-01/2.4; 139046-01/2.4; 139038-01/2.4; 139040-01/2.4; 139049-01/2.4; 139044-01/2.4; 139039-01/2.4; 139051-01/2.4; 139164-01/2.4; 139052-01/2.4; 139070-01/2.4; 139071-01/2.4; 139061-01/2.4; 139066-01/2.4; 139065-01/2.4; 139058-01/2.4; 139060-01/2.4; 139067-01/2.4; 139064-01/2.4; 139059-01/2.4; 139068-01/2.4; 139165-01/2.4; 139069-01/2.4. 1144-00/2.4; 1137-00/2.4; 1147-00/10885403517181/2.4 1145-00/10885403517167/2.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1545-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1545-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-09

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)