Manufacturer

CareFusion 303, Inc.

103 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 103

HighFDA (Devices)·Z-1552-2025·2025-04-23
BD Pyxis MedBank Receiving Cabinet Software Medication Dispensing Safety Issue
CareFusion 303 is recalling certain BD Pyxis MedBank Receiving Cabinet Software versions because a "Clear All" function may bypass pharmacist validation, potentially allowing incorrect medication dispensing without authorization.
Product
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK MINI MAIN, REF: 1147-00 BD PYXIS MEDBANK Facility Software, REF: 139090-01; BD PYXS MEDBNK TWR MN 2HH1FH2HM2FM2FG1FF, REF: 169-100; BD PYXIS MEDBANK MINI 1HH-1F
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1550-2025·2025-04-16
BD Pyxis MedBank CUBIE Replenishment Station software issue
A software issue in the BD Pyxis MedBank CUBIE Replenishment Station prevents medication restocking when users receive an error message, potentially delaying patient access to medications.
Product
BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P / 155140-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FH / 155142-01 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P / 155143-01 BD PYXI
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-1545-2025·2025-04-16
BD Pyxis automated dispensing cabinets recalled for software dosing bug
CareFusion 303 is recalling BD Pyxis MedBank and MedFlex automated dispensing cabinets due to a software bug that prevents accurate tracking of medication quantities, potentially causing patients to receive more than the intended dose.
Product
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1375-2025·2025-03-26
BD Pyxis Medication Dispensing Systems Software Sync Error Recall
BD Pyxis medication dispensing systems may disconnect from their server due to a software error, preventing them from receiving medication updates. This could lead to incorrect medication administration or delayed access to medications.
Product
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Desktop PC, REF: 1156-00, CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01, CII Safe ES Desktop PC, W-less SCNR, REF: 107-255-01,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1305-2025·2025-03-19
BD Care Coordination Engine Software May Send Outdated Programming Requests
BD Care Coordination Engine infusion software may send outdated automated programming requests to care units. Healthcare facilities in affected US states should review their systems.
Product
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software
Category
Medical Device
Distribution
21 states
SevereFDA (Devices)·Z-1304-2025·2025-03-19
BD Alaris Systems Manager Infusion Software Affected by Programming Request Issue
BD Alaris Systems Manager software may transmit outdated automated programming requests to progressive care units. The FDA has classified this as a Class I recall.
Product
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software
Category
Medical Device
Distribution
21 states
HighFDA (Devices)·Z-1206-2025·2025-03-05
BD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk
FDA is requiring labeling updates for BD Pyxis automated medication dispensing devices to address the risk of delays in medication access due to power loss or device malfunctions. The recall affects approximately 1,521 units distributed nationwide.
Product
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Category
Medical Device
Distribution
Distributed nationwide
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-1230-2025·2025-03-05
BD Pyxis MedBank medication cabinets recalled for operating room contraindication labeling
CareFusion is recalling BD Pyxis MedBank medication management cabinets due to inadequate labeling. A contraindication statement must be added to warn against use in procedure and operating rooms.
Product
139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS
Category
Medical Device
Distribution
Distributed nationwide
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-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
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
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
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-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
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-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
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
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-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-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
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-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-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