CareFusion 303, Inc.
Complete recall history across all FDA and CPSC categories — 164 total recalls
CareFusion 303, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (164)
FDA medical device enforcement actions by CareFusion 303, Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 11, 2026 | BD Alaris" System with Guardrails" Suite MX with Point of Care Unit | Due to product labeling not indicating which Transport Layer Security (TLS) v... | Class II |
| Dec 3, 2025 | BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 1... | Due a software issue that may result in equipment not receiving timely update... | Class II |
| Nov 20, 2025 | BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliar... | Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmw... | Class II |
| Nov 6, 2025 | BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD Alar... | Due to a number of modules flashed with a date and time associated with the d... | Class II |
| Oct 17, 2025 | BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF... | If infusion pump is dropped or severely jarred this may damage the pump modul... | Class I |
| Sep 30, 2025 | Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 11... | Potential fluid ingress of anesthesia station or med station may result in sm... | Class II |
| Sep 30, 2025 | All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 | Potential fluid ingress of anesthesia station or med station may result in sm... | Class II |
| Sep 30, 2025 | Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-0... | Potential fluid ingress of anesthesia station or med station may result in sm... | Class II |
| Sep 30, 2025 | Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139... | Potential fluid ingress of anesthesia station or med station may result in sm... | Class II |
| Sep 30, 2025 | BD Pyxis Pro MedStation Main, REF: 1155-00 | Potential fluid ingress of anesthesia station or med station may result in sm... | Class II |
| Sep 11, 2025 | BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, ... | Infusion pump module used with compatible pump infusion sets may perform ou... | Class I |
| Jul 10, 2025 | Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MI... | Reports of delayed access to medication in automated dispensing cabinets beca... | Class III |
| Jul 8, 2025 | BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions | Infusion pump module used with compatible pump infusion sets may perform ou... | Class I |
| Jul 8, 2025 | BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, B... | Infusion pump module used with compatible pump infusion sets may perform ou... | Class I |
| May 8, 2025 | BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 400... | Antivirus software was not consistently installed on impacted devices during ... | Class II |
| May 8, 2025 | Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD P... | During automated dispensing cabinet upgrade/installation/reimaging, component... | Class II |
| Mar 11, 2025 | BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-... | Users trying to restock a single bin location of an automated dispensing cabi... | Class II |
| Mar 11, 2025 | BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYX... | Due to a software issue, when attempting to restock the automated dispensing ... | Class II |
| Mar 11, 2025 | BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD P... | Due to a software bug, automated dispensing cabinet is unable to calculate co... | Class II |
| Feb 18, 2025 | BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software | Software issue that may result in outdated automated programming request(APR)... | Class I |
| Feb 18, 2025 | BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software | Software issue that may result in outdated automated programming request(APR)... | Class I |
| Feb 6, 2025 | BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedSt... | Sync timeout may occur between the server and automated dispensing device, du... | Class II |
| Jan 23, 2025 | BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The B... | Due to fingerprint scanner failing resulting in the scanner heating up. | Class II |
| Jan 23, 2025 | BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite ... | Due to User Manual/Direction for Use incorrectly instructing user to leave th... | Class II |
| Jan 10, 2025 | BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass,... | Automated dispensing device labeling is being updated to strengthen labeling ... | Class II |
| Jan 8, 2025 | (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station ... | Labeling is insufficient regarding delays in access to medication. The firm i... | Class II |
| Jan 8, 2025 | 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2... | Labeling update to include a contraindication statement against the use of me... | Class II |
| Jan 8, 2025 | 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM... | Labeling update to include a contraindication statement against the use of me... | Class II |
| Jan 8, 2025 | 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 100... | Labeling update to include a contraindication statement against the use of me... | Class II |
| Jan 8, 2025 | 138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR... | Labeling update to include a contraindication statement against the use of me... | Class II |
| Jan 8, 2025 | (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS)... | Software issues could potentially result in: 1) delays in accessing dispensin... | Class II |
| Nov 14, 2024 | BD Pyxis MedStation ES, REF: 323 | Due to a software issue, automated dispensing cabinet devices may open the wr... | Class II |
| Nov 14, 2024 | BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 | Due to a software issue, automated dispensing cabinet devices may open the wr... | Class II |
| Nov 14, 2024 | BD Pyxis CII Safe ES, REF: 1116-00 | Due to a software issue, automated dispensing cabinet devices may open the wr... | Class II |
| Aug 15, 2024 | Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not b... | Class II |
| Aug 15, 2024 | Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not b... | Class II |
| Aug 15, 2024 | Alaris Pump Module Model 8100, a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not b... | Class II |
| Aug 15, 2024 | Alaris PCA Module Model 8120, a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not b... | Class II |
| Aug 15, 2024 | Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system | Due to affected devices that may have bent female IUI connector and may not b... | Class II |
| Jul 9, 2024 | BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jul 9, 2024 | BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet... | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version... | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software ver... | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.... | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software versio... | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version... | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software ver... | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jun 24, 2024 | BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3... | Due to software issue, there is a potential when a restock label is printed f... | Class II |
| Jun 24, 2024 | BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version... | Due to software issue, there is a potential when a restock label is printed f... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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