Carefusion 303, Inc.
FDA adverse event reports naming Carefusion 303, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: CAREFUSION 303, INC..
- Total reports
- 90,065
- Deaths
- 38
- Injuries
- 157
- Malfunctions
- 89,823
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Cabinet, Table And Tray, AnesthesiaBRY82,768
- Pump, InfusionFRN5,810
- Set, Administration, IntravascularFPA1,094
- Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK218
- Pump, Infusion, PcaMEA156
- Syringe, PistonFMF4
- OximeterDQA2
- Biopsy NeedleFCG2
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ2
- Set, I.V. Fluid TransferLHI2
Recent recalls
- 2026-06-03Open, ClassifiedComponent design/selection
BD Pyxis MedStation 4000 REF: 303 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
- 2026-06-03Open, ClassifiedComponent design/selection
BD Pyxis MedStation ES REF: 323 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
- 2026-06-03Open, ClassifiedComponent design/selection
BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
- 2026-06-03Open, ClassifiedComponent design/selection
BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
- 2026-06-03Open, ClassifiedComponent design/selection
BD Pyxis Mini Main REF: 349 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
- 2026-06-03Open, ClassifiedComponent design/selection
BD Pyxis MedStation ES Tower REF: 352 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
- 2026-06-03Open, ClassifiedComponent design/selection
BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
- 2026-06-03Open, ClassifiedComponent design/selection
BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
- 2026-03-26Open, ClassifiedUnder Investigation by firm
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit
Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units
- 2026-01-29Open, ClassifiedUnder Investigation by firm
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia (PCA) Module, and associated software applications.
Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network
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