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Recall Observatory FDA recall evidence

Device product

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

Z-0962-2026

November 20, 2025

Class II

Product summary

Firm
CareFusion 303, Inc.
Event
Event 97712
Status
Ongoing
Classification
Class II
Quantity
53669
Official record key
device-enforcement:Z-0962-2026

Official wording

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.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    software to generate a duplicate address, which causes an error