FDA Device recall Z-2374-2024

BD Pyxis: MedStation ES (Main), REF: 323

FDA Device
Class II
ongoing
Published 2024-07-24

On 2024-07-24 the FDA classified a Class II recall of BD Pyxis: MedStation ES (Main), REF: 323 by Carefusion 303, citing if automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the prod….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2374-2024
Classification	Class II
Status	ongoing
Initiated	2024-05-02
Published	2024-07-24
Last updated	2026-09-13 11:57 UTC
Company	Carefusion 303
Distribution	US

Product

BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

Reason

If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.

Identifiers

code_info	REF/UDI-DI: 323/10885403512667, 352/10885403512674, 327/10885403477836, 1116-00/10885403512605 Software Version: ES 1.… REF/UDI-DI: 323/10885403512667, 352/10885403512674, 327/10885403477836, 1116-00/10885403512605 Software Version: ES 1.7.x Serial Numbers: 13534745, 16220738, 16446299, 16446303, 16446302, 16247443, 16247440, 15962990, 16417275, 16446297, 16446296, 16242783, 16234266, 15425093, 16446295, 16446291, 16242784, 16417277, 15644176, 14019332, 16212329, 16221517, 16395857, 16059358, 16254191, 15319466, 15154945, 15153602, 16215325, 15154942, 14959051, 16395855, 16395853, 16215313, 16361893, 14826969, 14826972, 14826971, 14826973, 14232856, 16241342, 13877154, 15148881, 15148860, 15148880, 15148882, 15854601, 15148883, 15148865, 15148885, 15160417, 16212961, 15854595, 15148859, 15148862, 15148861, 15148863, 15148866, 15148868, 15854596, 15854600, 15148870, 15854597, 15854598, 15854599, 15148873, 15148864, 15148867, 15148884,15148878, 15148879, 16324054, 16223557, 15136666, 13841400, 14138516, 15519749, 16446315, 16141586, 16416617, 16416618, 16416622, 16416619, 16416621, 16416623, 16416616, 1

code_info

REF/UDI-DI: 323/10885403512667, 352/10885403512674, 327/10885403477836, 1116-00/10885403512605 Software Version: ES 1.…

REF/UDI-DI: 323/10885403512667, 352/10885403512674, 327/10885403477836, 1116-00/10885403512605 Software Version: ES 1.7.x Serial Numbers: 13534745, 16220738, 16446299, 16446303, 16446302, 16247443, 16247440, 15962990, 16417275, 16446297, 16446296, 16242783, 16234266, 15425093, 16446295, 16446291, 16242784, 16417277, 15644176, 14019332, 16212329, 16221517, 16395857, 16059358, 16254191, 15319466, 15154945, 15153602, 16215325, 15154942, 14959051, 16395855, 16395853, 16215313, 16361893, 14826969, 14826972, 14826971, 14826973, 14232856, 16241342, 13877154, 15148881, 15148860, 15148880, 15148882, 15854601, 15148883, 15148865, 15148885, 15160417, 16212961, 15854595, 15148859, 15148862, 15148861, 15148863, 15148866, 15148868, 15854596, 15854600, 15148870, 15854597, 15854598, 15854599, 15148873, 15148864, 15148867, 15148884,15148878, 15148879, 16324054, 16223557, 15136666, 13841400, 14138516, 15519749, 16446315, 16141586, 16416617, 16416618, 16416622, 16416619, 16416621, 16416623, 16416616, 1

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2374-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.