1) Pyxis MedStation ES, Catalog No. 323 recallZ-1119-2025 · 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
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
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-1119-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 8, 2025
- Posted by the FDA
- Feb 7, 2025
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 137,741 total
- Product code
- BRY
- Distribution
- Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
Product description
(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
Code information (models, lots, serial numbers)
(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
Devices named in this recall
3 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
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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