BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR...
FDA Device Recall #Z-1550-2025 — Class II — March 11, 2025
Recall Summary
| Recall Number | Z-1550-2025 |
| 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 | 404 systems |
Product Description
BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 155144-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 155145-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 155156-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 155157-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P / 155151-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 155152-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 155153-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 155154-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 155155-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 155146-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 155147-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 155148-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 155149-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 155150-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 169-114 BD PYXIS MEDBANK MINI CR-4HH-P / 169-115 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 169-82 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 169-83 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 169-84 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 169-85 BD PYXIS MEDBANK TWR MN CR-14HH-P / 169-86 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 169-87 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 169-88 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 169-89 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 169-90 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 169-91 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 169-92 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /169-93 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 169-94 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 169-95 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 169-96 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 169-97 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 169-98 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 169-99 BD PYXIS MEDBANK MINI CR-2HH-1FH-P / 138913-01 BD PYXIS MEDBANK MINI CR-4HH-P / 138911-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P / 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P / 139002-01 BD PYXIS MEDBANK MN 200 CR-4HH-P / 139000-01 BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P / 139020-01 BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P / 139018-01 BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P / 139019-01 BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P / 139021-01 BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P / 139022-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 138973-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 138975-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 139073-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 138976-01 BD PYXIS MEDBANK TWR MN CR-14HH-P / 138977-01 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM / 138951-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH / 139072-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FM / 139085-01 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P / 138968-01 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P / 138964-01 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P / 138966-01 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P /138967-01 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P / 138969-01 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P / 138965-01 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P / 138971-01 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P / 138972-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P / 138974-01 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P / 138970-01 BD Pyxis QFill Replenishment Station / 138904-01 KIT BD PYXIS QFILL REPLENISHMENT STATION / 155197-01 MEDBANK UPOS211 AIO WIN10 QFILL 1.5 / 155215-05 OPT,MEDBANK,HD,WIN10,QFILL,CR / 131944-04 The BD Pyxis" MedBank" CUBIE" Replenishment Station is an Automated Dispensing Cabinet (ADC) that is intended to be used by a qualified and authorized user to replenish medications and supplies to a BD Pyxis" MedBank" cabinet.
Reason for Recall
Due to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has passed, or item has been removed from purchase order. Please contact Pharmacy for assistance". When this occurs, the medication cannot be restocked and can potentially lead to delays in accessing medication for patients.
Distribution Pattern
U.S.: AL,AZ, CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, TN, TX, UT, VA, WA, WI and WV. O.U.S.: None
Lot / Code Information
Product / Material ID / GTIN OPT,MEDBANK,HD,WIN10,QFILL,CR 131944-04 N/A BD Pyxis QFill Replenishment Station 138904-01 N/A BD PYXIS MEDBANK MINI CR-4HH-P 138911-01 N/A BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138913-01 N/A BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 138951-01 N/A BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 138964-01 N/A BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 138965-01 N/A BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 138966-01 N/A BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 138967-01 N/A BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 138968-01 N/A BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 138969-01 N/A BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 138970-01 N/A BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 138971-01 N/A BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 138972-01 N/A BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 138973-01 N/A BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 138974-01 N/A BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 138975-01 N/A BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 138976-01 N/A BD PYXIS MEDBANK TWR MN CR-14HH-P 138977-01 N/A BD PYXIS MEDBANK MN 200 CR-4HH-P 139000-01 N/A BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139001-01 N/A BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139002-01 N/A BD PYXIS MEDBANK MN 500 CR-2HH-5FM-P 139018-01 N/A BD PYXIS MEDBANK MN 500 CR-4HH-1FH-3FM-P 139019-01 N/A BD PYXIS MEDBANK MN 500 CR-2HH-1FM-2DD-P 139020-01 N/A BD PYXIS MEDBANK MN 500 CR-4HH-4FM-P 139021-01 N/A BD PYXIS MEDBANK MN 500 CR-6HH-3FM-P 139022-01 N/A BD PYXIS MEDBANK TWR MN CR-2HH-6FH 139072-01 N/A BD PYXIS MEDBANK TWR MN CR-12HH-1FH 139073-01 N/A BD PYXIS MEDBANK TWR MN CR-2HH-6FM 139085-01 N/A BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 155140-01 10885403504440 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 155141-01 10885403503580 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 155142-01 10885403504457 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 155143-01 10885403504464 BD PYXIS MEDBANK TWR MN CR-14HH-P 155144-01 10885403504471 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 155145-01 10885403504488 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 155146-01 10885403504754 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 155147-01 10885403504761 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 155148-01 10885403504778 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 155149-01 10885403504785 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 155150-01 10885403504792 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 155151-01 10885403504709 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 155152-01 10885403504716 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 155153-01 10885403504723 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 155154-01 10885403504730 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 155155-01 10885403504747 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 155156-01 10885403504624 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 155157-01 10885403504631 KIT BD PYXIS QFILL REPLENISHMENT STATION 155197-01 N/A MEDBANK UPOS211 AIO WIN10 QFILL 1.5 155215-05 N/A BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 10885403512544 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 10885403512544 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P 169-82 10885403512568 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P 169-83 10885403512568 BD PYXIS MEDBANK TWR MN CR-12HH-1FH 169-84 10885403512568 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P 169-85 10885403512568 BD PYXIS MEDBANK TWR MN CR-14HH-P 169-86 10885403512568 BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM 169-87 10885403512568 BD PYXIS MEDBANK TWR MN CR-2HH-6FH 169-88 10885403512568 BD PYXIS MEDBANK TWR MN CR-2HH-6FM 169-89 10885403512568 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P 169-90 10885403512568 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P 169-91 10885403512568 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P 169-92 10885403512568 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P 169-93 10885403512568 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P 169-94 10885403512568 BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P 169-95 10885403512568 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P 169-96 10885403512568 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P 169-97 10885403512568 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P 169-98 10885403512568 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P 169-99 10885403512568
Other Recalls from CareFusion 303, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1645-2026 | Class II | BD Alaris" System with Guardrails" Suite MX wit... | Feb 11, 2026 |
| Z-1028-2026 | Class II | BD Pyxis ES Enterprise Server Catalog Numbers 1... | Dec 3, 2025 |
| Z-0962-2026 | Class II | BD Pyxis MedStation ES, REF: 323, BD Pyxis M... | Nov 20, 2025 |
| Z-1217-2026 | Class II | BD Alaris" Pump Module model 8100 UDI-DI code:... | Nov 6, 2025 |
| Z-0430-2026 | Class I | BD Alaris infusion Pump Module 8100, REF: 8100;... | Oct 17, 2025 |
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.