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CareFusion 303, Inc.

159 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
BD Pyxis MedStation 4000 REF: 303 Medication cabinet recall (Z-2297-2026)CareFusion 303, Inc.2026-06-03
BD Pyxis MedStation ES REF: 323 Medication cabinet recall (Z-2298-2026)CareFusion 303, Inc.2026-06-03
BD Pyxis Anesthesia Station ES REF: 327 Medication cabinet recall (Z-2299-2026)CareFusion 303, Inc.2026-06-03
BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet recall (Z-2300-2026)CareFusion 303, Inc.2026-06-03
BD Pyxis Mini Main REF: 349 Medication cabinet recall (Z-2301-2026)CareFusion 303, Inc.2026-06-03
BD Pyxis MedStation ES Tower REF: 352 Medication cabinet recall (Z-2302-2026)CareFusion 303, Inc.2026-06-03
BD Pyxis MedBank Tower REF: 1145-00 Medication cabinet recall (Z-2303-2026)CareFusion 303, Inc.2026-06-03
BD Pyxis MedBank Mini REF: 1147-00 Medication cabinet recall (Z-2304-2026)CareFusion 303, Inc.2026-06-03
BD Alaris" System with Guardrails" Suite MX with Point of Care Unit recall (Z-1645-2026)CareFusion 303, Inc.2026-03-26
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with recall (Z-1217-2026)CareFusion 303, Inc.2026-01-29
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 1376 recall (Z-1028-2026)CareFusion 303, Inc.2026-01-08
BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324, BD recall (Z-0962-2026)CareFusion 303, Inc.2025-12-19
BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT recall (Z-0430-2026)CareFusion 303, Inc.2025-11-20
Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 114 recall (Z-0367-2026)CareFusion 303, Inc.2025-10-27
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 recall (Z-0368-2026)CareFusion 303, Inc.2025-10-27
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00 recall (Z-0369-2026)CareFusion 303, Inc.2025-10-27
BD Pyxis Pro MedStation Main, REF: 1155-00 recall (Z-0370-2026)CareFusion 303, Inc.2025-10-27
All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 recall (Z-0371-2026)CareFusion 303, Inc.2025-10-27
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 1 recall (Z-0035-2026)CareFusion 303, Inc.2025-10-08
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 108854 recall (Z-2477-2025)CareFusion 303, Inc.2025-08-28
Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI 4HM/169-113, recall (Z-2321-2025)CareFusion 303, Inc.2025-08-13
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions recall (Z-2179-2025)CareFusion 303, Inc.2025-08-06
BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, recall (Z-2180-2025)CareFusion 303, Inc.2025-08-06
Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistic recall (Z-2017-2025)CareFusion 303, Inc.2025-06-24
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1 recall (Z-1639-2025)CareFusion 303, Inc.2025-04-18
MEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK TOWE recall (Z-1552-2025)CareFusion 303, Inc.2025-04-11
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank recall (Z-1545-2025)CareFusion 303, Inc.2025-04-09
BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN recall (Z-1550-2025)CareFusion 303, Inc.2025-04-09
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, R recall (Z-1375-2025)CareFusion 303, Inc.2025-03-17
BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software recall (Z-1304-2025)CareFusion 303, Inc.2025-03-13
BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software recall (Z-1305-2025)CareFusion 303, Inc.2025-03-13
BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular recall (Z-1231-2025)CareFusion 303, Inc.2025-02-24
BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088- recall (Z-1206-2025)CareFusion 303, Inc.2025-02-21
BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is recall (Z-1207-2025)CareFusion 303, Inc.2025-02-21
138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 13 recall (Z-1227-2025)CareFusion 303, Inc.2025-02-21
155288-01 BD PYXIS MEDBANK MINI 1FH-1FM 169-137 BD PYXIS MEDBANK MINI 1FH-1FM 155311-01 BD recall (Z-1228-2025)CareFusion 303, Inc.2025-02-21
139054-01 BD PYXIS MEDFLEX MN 1000 10HH-1FM 139055-01 BD PYXIS MEDFLEX MN 1000 12HH 139053 recall (Z-1229-2025)CareFusion 303, Inc.2025-02-21
139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 16 recall (Z-1230-2025)CareFusion 303, Inc.2025-02-21
BD Pyxis MedStation ES (Med ES Main) REF: 323. Intended to securely store and dispense med recall (Z-1122-2025)CareFusion 303, Inc.2025-02-11
BD Pyxis MedStation Auxiliary ES REF: 324. Intended to securely store and dispense medicat recall (Z-1123-2025)CareFusion 303, Inc.2025-02-11
BD Pyxis MedStation Auxiliary 4000 REF: 306. Intended to securely store and dispense medic recall (Z-1124-2025)CareFusion 303, Inc.2025-02-11
BD Pyxis MedStation 4000 REF: 303. Intended to securely store and dispense medications to recall (Z-1125-2025)CareFusion 303, Inc.2025-02-11
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. recall (Z-1119-2025)CareFusion 303, Inc.2025-02-07
(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalo recall (Z-1120-2025)CareFusion 303, Inc.2025-02-07
BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The recall (Z-1050-2025)CareFusion 303, Inc.2025-01-30
BD Pyxis MedStation ES (Med ES Main), REF 323 recall (Z-0971-2025)CareFusion 303, Inc.2025-01-17
BD Pyxis MedStation ES AUX, REF 324 recall (Z-0972-2025)CareFusion 303, Inc.2025-01-17
BD Pyxis MedStation 4000 Main, REF 303 recall (Z-0973-2025)CareFusion 303, Inc.2025-01-17
BD Pyxis MedStation 4000 AUX, REF 306 recall (Z-0974-2025)CareFusion 303, Inc.2025-01-17
BD Pyxis Med ES Auxiliary (AUX), REF 343 recall (Z-0975-2025)CareFusion 303, Inc.2025-01-17
BD Pyxis Med 4000 Auxiliary (AUX), REF 314 recall (Z-0976-2025)CareFusion 303, Inc.2025-01-17
BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES (Med ES Main To recall (Z-0906-2025)CareFusion 303, Inc.2025-01-14
BD Pyxis MedStation ES, REF: 323 recall (Z-0670-2025)CareFusion 303, Inc.2024-12-11
BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324 recall (Z-0671-2025)CareFusion 303, Inc.2024-12-11
BD Pyxis CII Safe ES, REF: 1116-00 recall (Z-0672-2025)CareFusion 303, Inc.2024-12-11
Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system recall (Z-3138-2024)CareFusion 303, Inc.2024-09-13
Alaris PCA Module Model 8120, a modular infusion pump and monitoring system recall (Z-3139-2024)CareFusion 303, Inc.2024-09-13
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system recall (Z-3140-2024)CareFusion 303, Inc.2024-09-13
Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system recall (Z-3141-2024)CareFusion 303, Inc.2024-09-13
Alaris Pump Module Model 8100, a modular infusion pump and monitoring system recall (Z-3142-2024)CareFusion 303, Inc.2024-09-13
BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet system recall (Z-2947-2024)CareFusion 303, Inc.2024-08-30
BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet system recall (Z-2948-2024)CareFusion 303, Inc.2024-08-30
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, R recall (Z-1223-2024)CareFusion 303, Inc.2024-08-20
BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9 recall (Z-2485-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9 recall (Z-2486-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9 recall (Z-2487-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9 recall (Z-2488-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9 recall (Z-2489-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9 recall (Z-2490-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P, REF: 169-85 containing software version 3.9.1.9 recall (Z-2491-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9 recall (Z-2492-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9 recall (Z-2493-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-2HH-6FM, REF: 169-89 containing software version 3.9.1.9 recall (Z-2494-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9 recall (Z-2495-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9 recall (Z-2496-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9 recall (Z-2497-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9 recall (Z-2498-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9 recall (Z-2499-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P, REF: 169-96 containing software version 3.9.1.9 recall (Z-2500-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9 recall (Z-2501-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9 recall (Z-2502-2024)CareFusion 303, Inc.2024-08-02
BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9 recall (Z-2503-2024)CareFusion 303, Inc.2024-08-02
BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Statio recall (Z-2374-2024)CareFusion 303, Inc.2024-07-17
BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units recall (Z-2262-2024)CareFusion 303, Inc.2024-07-03
BD Pyxis, Name/REF: MEDBANK MINI 1FH-1FM/ 169-137, MEDBANK MINI 1FH-2HH MEDPASS/ 169-151, recall (Z-2255-2024)CareFusion 303, Inc.2024-07-02
BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, B recall (Z-2256-2024)CareFusion 303, Inc.2024-07-02
BD Pyxis MedStation ES, REF: 323, Medication Cabinet recall (Z-1927-2024)CareFusion 303, Inc.2024-05-30
BD Pyxis MedStation 4000 System, REF: 303, Medication Cabinet recall (Z-1928-2024)CareFusion 303, Inc.2024-05-30
BD Pyxis" MedStation ES 7-Drawer Auxiliary Tower, REF: 324 recall (Z-1929-2024)CareFusion 303, Inc.2024-05-30
BD Pyxis MedStation 4000 7-Drawer Auxiliary Tower, REF: 306 recall (Z-1930-2024)CareFusion 303, Inc.2024-05-30
BD Pyxis" Anesthesia Station ES, REF: 327 recall (Z-1931-2024)CareFusion 303, Inc.2024-05-30
BD Pyxis(TM) Anesthesia Station 4000, REF: 338 recall (Z-1932-2024)CareFusion 303, Inc.2024-05-30
BD Alaris PCU REF 8015 recall (Z-0184-2024)CareFusion 303, Inc.2023-11-07
BD Alaris Syringe Module, REF 8110 recall (Z-0185-2024)CareFusion 303, Inc.2023-11-07
Alaris PCA Module 8120 recall (Z-0186-2024)CareFusion 303, Inc.2023-11-07
BD Pyxis CII Safe ES, REF: 1116-00; and BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF recall (Z-0093-2024)CareFusion 303, Inc.2023-10-10
BD Pyxis MedBank MedPass Software, REF: 139088-01 recall (Z-2646-2023)CareFusion 303, Inc.2023-09-28
BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Softw recall (Z-2094-2023)CareFusion 303, Inc.2023-07-05
BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower) recall (Z-1579-2023)CareFusion 303, Inc.2023-05-11
BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), RE recall (Z-1207-2023)CareFusion 303, Inc.2023-03-17
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Every clearance here is in the API, with alerts when new ones post.