FDA Recall Open, Classified

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

Recall: Z-0962-2026 · Initiated November 20, 2025

Recall

Recall Number
Z-0962-2026
Event Number
97712
Firm
CareFusion 303, Inc.
FEI Number
2016493
Product Code
BRY
Status
Open, Classified
Root Cause
Device Design
Initiated
November 20, 2025
Posted
December 19, 2025
Address
10020 Pacific Mesa Blvd, San Diego, CA, 92121-4386

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

Reason

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.

Action

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

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.

Quantity

53669