Z-0906-2025Class II

BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352

Name: Z-0906-2025 BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Creator: CareFusion 303, Inc.
Published: 2023-04-05
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2023-04-05 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352 on 2023-04-05. FDA classified it as Class II and gives the reason as "Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0906-2025
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-05
Posted: 2025-01-14
Recalling firm: CareFusion 303, Inc
Product: BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.
Root cause tag: software
FDA root cause: Software design
Action: On 4/5/2023, correction notices were sent to customers who were asked to do the following: A permission-based feature called "Global Find" can be used to obtain alternate storage locations of medication(s) not loaded (by pharmacy) or depleted at that device and is not impacted by this issue. 1) Review and confirm that backup procedures (which may include but may not necessarily be limited to keys, emergency medication supplies, alternate devices in proximity, etc.) are in place and staff have all been properly trained on them to avoid delays in access to medications. 2) Ensure this letter is forwarded to applicable facilities if devices have been transferred and that all appropriate personnel have been made aware of this issue. 3) Complete and return the enclosed Customer Response Form via email to [email protected] 4) Adverse health consequences experienced with the use of this product should be reported to BD at 1-800-727-6102 or via bd.com/self-service. Recall/Letter Questions: BD Customer Support, Phone: 1-866-583-8783, Phone Hours: 5:00am PST to 4:00pm PST (8:00am ET to 7:00pm ET), Monday - Friday A software update is available. BD will contact you to schedule a time to install the software update.
Quantity in commerce: 622
Distribution: US Nationwide distribution in the states of NY, NC, LA.
Product codes and lots: Software v1.7.3. REF/UDI-DI: 323/10885403512667, 352/10885403512674

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0906-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0906-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)