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BD Pyxis MedStation ES, REF: 323 recallZ-0962-2026 · CareFusion 303, Inc. · initiated Nov 20, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.

FDA root cause category: Device Design

What the company is doing

On 11/20/2025, correction notices were mailed and emailed to customers: 1) If a pocket fails with the error message of "Duplicate Address Detected," users with the proper permissions can leverage the "Recover Storage Space" functionality to eject the affected pocket and clear the error. Note: This does not resolve the Firmware v1.48 issue. This only clears the error message from the "Recover Storage Space" screen. Content stored within the affected CUBIE pocket will still need to be manually accessed once the CUBIE pocket is ejected. 2) Facilities should have comprehensive policies and procedures that outline alternative ways to access items, which may include removing from a different device or from pharmacy. 3. A redundant supply of all life sustaining medication should be kept in a nearby location to help mitigate the length of delay. 4. Firm recommends making a "code-box" or "crash cart" of medications that are readily available outside of an automated storage device in the event of an emergency. Facility policies and procedures should clearly identify when it is appropriate to access emergency medications. Refer to product user guide for additional information. 5. Keys can be used to manually access unavailable drawers. Keys must be readily available and retrievable to constitute risk mitigation. Hospital policies and procedures should be devised by the facility indicating location of keys along with how they are to be obtained and used in downtime scenarios. 6. Share and disseminate this notice within your facility network. 7. Complete and return the response form via email to [email protected] Firm will install the firmware 1.49 upgrade either remotely or via a field service visit. Note: Firmware updates to main devices will update the Aux when connected to the main device. Firm contacts: Remediation Support: [email protected] Technical Support: bd.com/self-service, Phone:1-800-727-6102

Recall details

Recall number
Z-0962-2026
Status
Open, Classified
Initiated by the company
Nov 20, 2025
Posted by the FDA
Dec 19, 2025
Recalling firm
CareFusion 303, Inc.
Quantity
53669
Product code
BRY
Distribution
Worldwide - US Nationwide distribution including in the states of CO, IN, OH, TX, KS, FL, GA, NC, CA, HI, IL, NY, MI, VA, AL, LA, NE, KY, OK, AR, TN, WY, NJ, WI, SD, AZ, NV, MO, MA, ID, WV, DE, PA, WA, MT, CT, IA, MD, PR, MN, NM, OR, VT, MS, ME, AK, UT, DC, GU, SC, NH, RI, ND, AS and the countries of CH, CA, KW, QA, NL, GB, UY, AU, NZ, BH, TH, SG, CN, FR, LB, BS, HK, TR, PL, AR, BR, CL, CO, MX, ES, BM, SA, IL.

Product description

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower, REF: 352, BD Pyxis Pro 7-Drawer Auxiliary, REF: 1149-00, BD Pyxis Pro 7- Drawer Auxiliary with Secure Tower, REF: 1152-00, BD Pyxis Pro MedStation Main, REF: 1155-00, BD Pyxis CII Safe ES, REF: 1116-00

Code information (models, lots, serial numbers)

Firmware Version: 1.48. REF/UDI-DI: 323/10885403512667, 324/10885403512681, 352/10885403512674, 1149-00/10885403517822, 1152-00/10885403517839, 1155-00/10885403521300, 1116-00/10885403512605

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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