FDAClass IIApril 16, 2025

BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower recall: Software Issue

BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended…

Why was BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended…
Recalling firm
CareFusion 303, Inc.
Quantity
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.
Recall date
April 16, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls