(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 3...
FDA Device Recall #Z-1120-2025 — Class II — January 8, 2025
Recall Summary
| Recall Number | Z-1120-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 8, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CareFusion 303, Inc. |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 193067 |
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
Reason for Recall
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Distribution Pattern
Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.
Lot / Code Information
(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)
Other Recalls from CareFusion 303, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1645-2026 | Class II | BD Alaris" System with Guardrails" Suite MX wit... | Feb 11, 2026 |
| Z-1028-2026 | Class II | BD Pyxis ES Enterprise Server Catalog Numbers 1... | Dec 3, 2025 |
| Z-0962-2026 | Class II | BD Pyxis MedStation ES, REF: 323, BD Pyxis M... | Nov 20, 2025 |
| Z-1217-2026 | Class II | BD Alaris" Pump Module model 8100 UDI-DI code:... | Nov 6, 2025 |
| Z-0430-2026 | Class I | BD Alaris infusion Pump Module 8100, REF: 8100;... | Oct 17, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.