Manufacturer

CareFusion 303, Inc.

95 recalls in our database name CareFusion 303, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 95

HighFDA (Devices)·Z-1231-2025·2025-03-05
Infusion Pump Manual Instructs Users to Leave Safety Clamp Open
BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.
Product
BD Alaris Pump Module REF 8100 The BD Alaris 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 administra
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1207-2025·2025-03-05
Automated Medication Cabinet Recalled Due to Fingerprint Scanner Overheating Risk
CareFusion's BD Pyxis MedFlex automated medication cabinet is being recalled due to fingerprint scanner failure and overheating, posing a potential fire hazard in clinical settings.
Product
BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Cabinet (ADC) intended to securely store and dispense medications and supplies to a qualified and authorized user in a clinical setting.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1229-2025·2025-03-05
BD PYXIS medication cabinets labeling update: operating room contraindication
CareFusion is updating labeling for BD PYXIS medication management cabinets to add a contraindication statement prohibiting use in procedure and operating rooms.
Product
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2HH-2FH-3FM 139041-01 BD PYXIS MEDFLEX MN 1000 2HH-2FM 139046-01 BD PYXIS MEDFLEX MN 1000 2HH-5FM 139038-01 BD PYXIS MEDFLEX MN 1000 3FM 139040-01 BD PYXIS MEDFL
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1228-2025·2025-03-05
BD PYXIS MEDBANK Medication Systems: Labeling Update for Operating Room Restriction
CareFusion is updating labeling for BD PYXIS MEDBANK medication systems to include a contraindication against use in procedure and operating rooms. Healthcare facilities should review updated labeling and ensure appropriate device placement.
Product
155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 138921-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 155159-01 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 169-101 BD PYXIS MEDBANK MINI 1HH-1FH-1HM 139122-01 BD PYXIS MEDBANK MINI
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1227-2025·2025-03-05
BD PYXIS MEDBANK systems operating room contraindication labeling update
BD PYXIS MEDBANK medication management systems are subject to a labeling update adding a contraindication against use in procedure and operating rooms. Approximately 6,075 units were distributed nationwide.
Product
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 138911-01 BD PYXIS MEDBANK MINI CR-4HH-P 169-115 BD PYXIS MEDBANK MINI CR-4HH-P 139001-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FH-P 139002-01 BD PYXIS MEDBANK MN 200 CR-2HH-1FM-P 139000-01 BD PYXIS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1122-2025·2025-02-19
BD Pyxis MedStation ES Medication Cabinet Drawer and Door Failures Recalled
The FDA is recalling BD Pyxis MedStation ES medication cabinets due to potential drawer and door failures that could delay medication access. Affected healthcare facilities should check their devices and contact the manufacturer if malfunctions occur.
Product
BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2025·2025-02-19
Medication Cabinet Recall: BD Pyxis MedStation Auxiliary 4000 Drawer and Door Failures
The BD Pyxis MedStation Auxiliary 4000 medication cabinet may experience drawer and door failures, potentially delaying medication access in healthcare facilities.
Product
BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1119-2025·2025-02-19
Pyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities
CareFusion recalls Pyxis medication dispensing systems due to software issues that could delay access to medications, result in incorrect doses, or allow unauthorized access.
Product
(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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1123-2025·2025-02-19
BD Pyxis MedStation Auxiliary ES medication cabinet drawer and door failures
BD Pyxis MedStation Auxiliary ES medication cabinets are being recalled due to potential drawer and door failures following increased complaints. The failures could delay access to medications stored in the cabinet.
Product
BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1125-2025·2025-02-19
BD Pyxis MedStation 4000 Recalled for Drawer and Door Failures
CareFusion 303, Inc. is recalling the BD Pyxis MedStation 4000 medication cabinet due to potential drawer and door failures that could delay access to stored medications.
Product
BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized healthcare provider.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1120-2025·2025-02-19
BD Pyxis Medication Dispensing Systems Recalled for Insufficient Labeling
CareFusion is recalling six models of BD Pyxis medication management systems due to insufficient labeling regarding potential delays in medication access. The manufacturer is strengthening product labeling to address this risk.
Product
(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 Anesthes
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1050-2025·2025-02-05
BD Pyxis MedStation Door Latch Assembly Failures in Automated Dispensing Cabinets
The FDA is recalling approximately 33,589 BD Pyxis MedStation automated dispensing cabinets due to door latch assembly failures that may leave doors open, potentially delaying medication access and enabling medication diversion.
Product
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES and Pyxis" MedStation 4000 are automated dispensing cabinets (ADC) that are intended to securely store and dispense medications to a qualified and authorized he
Category
Medical Device
Distribution
54 states
HighFDA (Devices)·Z-0976-2025·2025-01-29
BD Pyxis Med 4000 Auxiliary Drawer and Door Failures Delay Medication Access
CareFusion 303, Inc. is recalling 5 units of the BD Pyxis Med 4000 Auxiliary medication dispensing system due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.
Product
BD Pyxis Med 4000 Auxiliary (AUX), REF 314
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0971-2025·2025-01-29
BD Pyxis MedStation ES Medication Dispenser Drawer and Door Failure Recall
BD Pyxis MedStation ES medication dispensing units may experience drawer and door failures due to latch failure, cable ribbon damage, or magnet displacement. These failures could delay access to medications in healthcare facilities.
Product
BD Pyxis MedStation ES (Med ES Main), REF 323
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0973-2025·2025-01-29
BD Pyxis MedStation 4000 Medication Dispenser Recalled for Door Failures
BD Pyxis MedStation 4000 medication dispensers are recalled due to drawer and door failures that may delay medication access. The recall affects 13,055 units distributed worldwide.
Product
BD Pyxis MedStation 4000 Main, REF 303
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0972-2025·2025-01-29
BD Pyxis MedStation ES AUX medication dispenser drawer and door failures
The BD Pyxis MedStation ES AUX medication dispenser may experience drawer and door failures due to latch, cable, or magnet defects, potentially delaying access to medications. Approximately 39,615 units are affected worldwide.
Product
BD Pyxis MedStation ES AUX, REF 324
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0974-2025·2025-01-29
BD Pyxis MedStation 4000 Medication Cabinet Drawer and Door Failures
CareFusion 303 is recalling 5,056 BD Pyxis MedStation 4000 AUX units worldwide due to drawer and door failures that may delay medication access. Failures include door latch failure, cable ribbon damage, and magnet falling out.
Product
BD Pyxis MedStation 4000 AUX, REF 306
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0975-2025·2025-01-29
BD Pyxis Med ES Medication Cabinet Drawer and Door Failure Recall
CareFusion recalls the BD Pyxis Med ES Auxiliary medication cabinet due to drawer and door failures that may delay access to medications. Three failure modes identified: door latch failure, cable ribbon damage, and magnet falling out.
Product
BD Pyxis Med ES Auxiliary (AUX), REF 343
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0906-2025·2025-01-22
BD Pyxis MedStation ES software issue may delay medication dispensing
A software bug in BD Pyxis MedStation ES medication dispensing cabinets may prevent staff from locating alternate supply locations, potentially delaying patient therapy.
Product
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0672-2025·2024-12-18
BD Pyxis medication dispensing cabinet software issue risks wrong medication access
A software issue in the BD Pyxis CII Safe ES automated dispensing cabinet may cause it to open the wrong medication pocket, risking incorrect medication removal or refills.
Product
BD Pyxis CII Safe ES, REF: 1116-00
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0671-2025·2024-12-18
Automated Dispensing Cabinet Software Flaw May Cause Medication Dispensing Errors
The BD Pyxis MedStation ES automated dispensing cabinet may dispense the wrong medication due to a software issue, potentially causing medication errors and inventory shortages.
Product
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0670-2025·2024-12-18
BD Pyxis MedStation ES Automated Medication Cabinet Recalled for Software Defect
An automated medication dispensing cabinet may open the wrong storage pocket due to a software malfunction, potentially leading to incorrect medication removal. The manufacturer is recalling affected units.
Product
BD Pyxis MedStation ES, REF: 323
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3141-2024·2024-09-25
Alaris Syringe Module Model 8110 Infusion Pumps Recalled for Bent Connectors
CareFusion's Alaris Syringe Module Model 8110 infusion pumps are being recalled because affected units may have bent female connectors that can prevent device operation and delay infusions. Approximately 20,145 units have been distributed worldwide.
Product
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3142-2024·2024-09-25
Alaris Pump Module 8100 Recalled for Bent Connector That May Disable Device
CareFusion is recalling approximately 192,964 Alaris Pump Module Model 8100 infusion pumps that may have bent female connectors preventing device operation and delaying patient treatment.
Product
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3139-2024·2024-09-25
Alaris PCA Pump Module May Have Defective IUI Connector
CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.
Product
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
Category
Medical Device
Distribution
Distributed nationwide