1) BD Pyxis MedStation ES, Catalog No. 323 recallZ-1120-2025 · CareFusion 303, Inc. · initiated Jan 8, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
FDA root cause category: Labeling design
What the company is doing
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
Recall details
- Recall number
- Z-1120-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 8, 2025
- Posted by the FDA
- Feb 7, 2025
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 193067
- Product code
- BRY
- Distribution
- Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.
Product description
(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
Code information (models, lots, serial numbers)
(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)
Devices named in this recall
7 devices in the FDA device registry whose identifier appears in the recall's code information.
- BD Pyxis 323Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA14 recalls2 deaths24,375 reports
- Pyxis 327Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA10 recalls3,137 reports
- BD Pyxis 352Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA12 recalls898 reports
- Pyxis 303Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA7 recalls392 reports
- BD Pyxis 306Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA5 recalls134 reports
- Pyxis 338Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA3 recalls24 reports
- BD Pyxis SW-PAS-4000-V6Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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