FDA recall record · openFDA
CareFusion 303, Inc.
101 FDA recalls on record (2023–2026) — 101 device. 101 still ongoing.
9
Class I (most serious)
91
Class II
1
Class III
101
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispens 19
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. 11
Fingerprint scanner may overheat to a temperature to cause 1st degree burn. 8
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which d 6
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in 5
Recalls
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Class I 2025-09-11 BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software Class I 2025-02-18 BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, Class I 2025-10-17 BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60 Class I 2025-07-08 BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software Class I 2025-02-18 BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions Class I 2025-07-08 Alaris PCA Module 8120 Class I 2023-09-15 BD Alaris Syringe Module, REF 8110 Class I 2023-09-15 BD Alaris PCU REF 8015 Class I 2023-09-15 BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet Class II 2026-04-30 BD Pyxis Mini Main REF: 349 Medication cabinet Class II 2026-04-30 BD Alaris" System with Guardrails" Suite MX with Point of Care Unit Class II 2026-02-11 BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet Class II 2026-04-30 BD Pyxis MedStation ES REF: 323 Medication cabinet Class II 2026-04-30 BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet Class II 2026-04-30 BD Pyxis MedStation 4000 REF: 303 Medication cabinet Class II 2026-04-30 BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet Class II 2026-04-30 BD Pyxis MedStation ES Tower REF: 352 Medication cabinet Class II 2026-04-30 BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD Pyxis MedStation ES Tower Class II 2025-11-20 BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispen Class II 2025-03-11 BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitorin Class II 2025-01-23 BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, Class II 2025-12-03 BD Pyxis Pro MedStation Main, REF: 1155-00 Class II 2025-09-30 (1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Class II 2025-01-08 Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 13 Class II 2025-09-30 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 Class II 2025-01-08 Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4 Class II 2025-05-08 139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053-01 BD PYXIS MEDFLEX MN 1000 2 Class II 2025-01-08 Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00 Class II 2025-09-30 BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P / 155141-01 Class II 2025-03-11 BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF Class II 2025-02-06 155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD PYXIS MEDBANK MINI 1FH-2HH 13 Class II 2025-01-08 139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2H Class II 2025-01-08 BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis use Class II 2025-01-10 BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH- Class II 2025-03-11 (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedSta Class II 2025-01-08 BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated Dispensing Class II 2025-01-23 BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" Class II 2025-05-08 BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a Class II 2025-11-06 All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 Class II 2025-09-30 Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903- Class II 2025-09-30 Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system Class II 2024-08-15 BD Pyxis(TM) Anesthesia Station 4000, REF: 338 Class II 2024-04-15 BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352; Class II 2024-02-01 BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9 Class II 2024-06-24 BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9 Class II 2024-06-24 Alaris Pump Module Model 8100, a modular infusion pump and monitoring system Class II 2024-08-15 BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, MEDBANK MINI 1HH-1FH-1HM/ Class II 2024-05-13 BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9 Class II 2024-06-24 BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 1 Class II 2024-05-13 BD Pyxis CII Safe ES, REF: 1116-00 Class II 2024-11-14 BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 Class II 2024-11-14 Alaris PCA Module Model 8120, a modular infusion pump and monitoring system Class II 2024-08-15 BD Pyxis" Anesthesia Station ES, REF: 327 Class II 2024-04-15 BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9 Class II 2024-06-24 Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system Class II 2024-08-15 BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units Class II 2024-05-21 BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES Class II 2024-05-02 BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system Class II 2024-07-09 BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet Class II 2024-04-15 BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to a qualified and authorized he Class II 2024-02-23 BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis MedStation ES, REF: 323 Class II 2024-11-14 BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis MedStation ES, REF: 323, Medication Cabinet Class II 2024-04-15 Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system Class II 2024-08-15 BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306 Class II 2024-04-15 BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9 Class II 2024-06-24 BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 Class II 2024-06-24 BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system Class II 2024-07-09 BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9 Class II 2024-06-24 BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medications to a qualified and aut Class II 2024-02-23 BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9 Class II 2024-06-24 BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9 Class II 2024-06-24 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9 Class II 2024-06-24 BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense medications to a qualified and Class II 2024-02-23 BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medications to a qualified and autho Class II 2024-02-23 BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324 Class II 2024-04-15 BD Pyxis Med ES Auxiliary (AUX), REF 343 Class II 2023-02-14 Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards, with IP addresses from x.x.x.224 to x.x Class II 2023-01-24 BD Pyxis MedBank MedPass Software, REF: 139088-01 Class II 2023-08-18 MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWER MAIN, REF: 1145-00; MEDBANK Class II 2023-10-05 BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis" MedStation ES Class II 2023-02-14 BD Pyxis MedStation 4000 Main, REF 303 Class II 2023-02-14 BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main Tower), REF: 352 Class II 2023-04-05 BD Pyxis Med 4000 Auxiliary (AUX), REF 314 Class II 2023-02-14 BD Pyxis MedStation ES (Med ES Main), REF 323 Class II 2023-02-14 BD Pyxis MedStation 4000 AUX, REF 306 Class II 2023-02-14 BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224 Class II 2023-05-22 BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesi Class II 2023-04-05 BD Pyxis MedStation ES AUX, REF 324 Class II 2023-02-14 BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desk Class II 2023-09-06 BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Class II 2023-02-14 Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, BD PYXIS MEDBANK MINI 4HH Class III 2025-07-10
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.