Z-0962-2026Class II

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES...

Name: Z-0962-2026 BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES...
Creator: CareFusion 303, Inc.
Published: 2025-11-20
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-11-20 / Open, Classified / root cause: design

FDA source

CareFusion 303, Inc. began a recall of 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... on 2025-11-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0962-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-20
Posted: 2025-12-19
Recalling firm: CareFusion 303, Inc
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
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
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
Quantity in commerce: 53669
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 codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0962-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0962-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-19

Product code BRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)