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BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPa...

FDA Device Recall #Z-1545-2025 — Class II — March 11, 2025

Recall Summary

Recall Number Z-1545-2025
Classification Class II — Moderate risk
Date Initiated March 11, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CareFusion 303, Inc.
Location San Diego, CA
Product Type Devices
Quantity 7357

Product Description

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.

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.

Distribution Pattern

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.

Lot / Code Information

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; 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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

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Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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