Z-1120-2025Class II

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

Name: Z-1120-2025 (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD...
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: labeling and UDI

FDA source

CareFusion 303, Inc. began a recall of (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD... on 2025-01-08. FDA classified it as Class II and gives the reason as "Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1120-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-08
Posted: 2025-02-07
Recalling firm: CareFusion 303, Inc
Product: (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338
Product code: BRY Cabinet, Table And Tray, Anesthesia
Reason for recall: Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On January 8, 2025, the firm notified customers through an "Urgent Medical Device Correction" letter sent via email and mailed notices. In addition to explaining software issues affecting the device (covered in RES 96055), the letter also provided customers with a list of mitigations that address device downtime as a result of power failure, network failure, or hardware failure. The firm will be updating product labeling and product guides to further strengthen recommendations. On September 25, 2025, additional correction notices were distributed identifying additional affected devices. If you require further assistance contact the firm: Technical Support for technical questions: bd.com/self-service, 1-800-727-6102, Hours: 24 hours, 7 days a week; BD Recall Operations to return the customer response form: [email protected], Fax: (312) 949-0229
Quantity in commerce: 193067
Distribution: Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.
Product codes and lots: (1)BD Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) BD Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; ALL serial numbers; software versions v1.10 and prior. (4) BD Pyxis MedStation 4000 Console, Catalog No. 309, All serial numbers and all software versions, UDI-DI: 10885403512636; (5) BD Pyxis MedStation 4000, Catalog No. 303, All serial numbers and all software versions, UDI-DI: 10885403512629 (HW), 10885403513787 (SW); (6) BD Pyxis Anesthesia System 4000, Catalog No. 338, All serial numbers and all software versions, UDI-DI: 10885403477829 (HW), 10885403513787 (SW)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1120-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1120-2025	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)