Data Foundry

Medical device recalls 2023

BD Pyxis Anesthesia ES System — Class II medical device recall Z-1207-2023

Ongoing recall by CareFusion 303, Inc., reported 2023-03-29, distributed nationwide. Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of d

Recall numberZ-1207-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCareFusion 303, Inc., San Diego, CA, United States
Recall initiated2023-02-14
Classified2023-03-17
Reported by FDA2023-03-29
DistributedNationwide (US)
Countries outside the USCA
Quantity7,914
Reason classessoftware
UPC / GTIN / UDI-DI10885403477836, 10885403512667, 10885403512674
Model numbers323, 327, 352

Product

BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES Tower (Med ES Tower), REF: 352; all with BD Pyxis ES version 1.6.1 drawer firmware (version 1.10.2.5). Pyxis MedStation Enterprise Server (ES) System is an automated medication dispensing system supporting decentralized medication management in a pharmaceutical environment.

Reason for recall

Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1207-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.