Z-1119-2025Class II

(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis...

Name: Z-1119-2025 (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis...
Creator: CareFusion 303, Inc.
Published: 2025-01-08
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2025-01-08 / Open, Classified / root cause: software

FDA source

CareFusion 303, Inc. began a recall of (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII... on 2025-01-08. FDA classified it as Class II and gives the reason as "Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues". 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-1119-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-08
Posted: 2025-02-07
Recalling firm: CareFusion 303, Inc
Product: (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
Root cause tag: software
FDA root cause: Software design
Action: On January 8, 2025, the firm notified customers via email and mailed letter titled "Urgent Medical Device Correction". Firm states customers can continue to use Pyxis products in accordance with their labeling and any previously provided field action notifications, including the following guidance: 1. Facilities should establish policies and procedures for when an automated dispensing system is unavailable. 2. Device Keys can manually access unavailable drawers, but must be readily available and retrievable to adequately mitigate the risk. 3. Emergency supplies should be physically available in care areas for critical or urgent medications. 4. If using critical override mode to access contents of the device, users must use extra precautions and verify correct medications are selected. The firm anticipates releasing software update ES 1.11 beginning June 2025, which will address these software issues.
Quantity in commerce: 137,741 total
Distribution: Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
Product codes and lots: (1) Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00, UDI-DI 10885403512605; All Serial Numbers; Software Versions v1.10 and prior Affected

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1119-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1119-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-02-19	2025-02-07

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)