CareFusion 303, Inc.
FDA Regulatory Profile
CareFusion 303, Inc. appears in FDA public data with 173 recalls — including 38 Class I (most serious) —, 7 510(k) clearances, 13 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2301-2026, Class II) was initiated on April 30, 2026. Its most recent 510(k) clearance was granted on April 25, 2025.
Summary
- Total Recalls
- 173 (38 Class I)
- 510(k) Clearances
- 7
- Inspections
- 13
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2301-2026 | Class II | BD Pyxis Mini Main REF: 349 Medication cabinet | April 30, 2026 |
| Z-2300-2026 | Class II | BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet | April 30, 2026 |
| Z-2302-2026 | Class II | BD Pyxis MedStation ES Tower REF: 352 Medication cabinet | April 30, 2026 |
| Z-2299-2026 | Class II | BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet | April 30, 2026 |
| Z-2298-2026 | Class II | BD Pyxis MedStation ES REF: 323 Medication cabinet | April 30, 2026 |
| Z-2303-2026 | Class II | BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet | April 30, 2026 |
| Z-2304-2026 | Class II | BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet | April 30, 2026 |
| Z-2297-2026 | Class II | BD Pyxis MedStation 4000 REF: 303 Medication cabinet | April 30, 2026 |
| Z-1645-2026 | Class II | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | February 11, 2026 |
| Z-1028-2026 | Class II | BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 13 | December 3, 2025 |
| Z-0962-2026 | Class II | BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis | November 20, 2025 |
| Z-1217-2026 | Class II | BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardr | November 6, 2025 |
| Z-0430-2026 | Class I | BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY O | October 17, 2025 |
| Z-0369-2026 | Class II | Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00 | September 30, 2025 |
| Z-0371-2026 | Class II | All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 | September 30, 2025 |
| Z-0368-2026 | Class II | Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 1390 | September 30, 2025 |
| Z-0367-2026 | Class II | Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 | September 30, 2025 |
| Z-0370-2026 | Class II | BD Pyxis Pro MedStation Main, REF: 1155-00 | September 30, 2025 |
| Z-0035-2026 | Class I | BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron | September 11, 2025 |
| Z-2321-2025 | Class III | Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PY | July 10, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243855 | BD Alaris Infusion System with Guardrails Suite MX | April 25, 2025 |
| K211218 | BD Alaris System with Guardrails Suite MX v12.1.2 | July 21, 2023 |
| K171957 | MaxZero Extension Sets with Needless Connector | July 19, 2017 |
| K163316 | Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System | June 22, 2017 |
| K133532 | ALARIS SYSTEM WITH GUARDRAILS SUITE MX | August 21, 2014 |
| K110535 | ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION | March 26, 2012 |
| K110809 | WIRELESS MONITORING SYSTEM | July 5, 2011 |