Unrated Medical device recall · FDA · Published September 6, 2023

BD Pyxis CII Safe ES Software Update Risk: Controlled Substances Diversion

BD Pyxis CII Safe ES software versions 1.7.3 and 1.7.4 may overwrite controlled substance properties without warning, risking diversion of controlled substances. Affected units include specific model numbers and software versions.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0093-2024Medical device BD Pyxis ›

Recall notice

When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.

Take action

Contact the company

Recalling firmCareFusion 303, Inc.10020 Pacific Mesa Blvd · San Diego, CA 92121-4386

✎ GovInfoNow plain-language explainer

BD Pyxis CII Safe ES software versions 1.7.3 and 1.7.4 may overwrite controlled substance properties without warning, potentially allowing diversion of controlled substances. This recall affects healthcare facilities using these systems for medication management. Read more at govinfonow.com/recall/57379-bd-pyxis-cii-safe-es-software-update-risk-controlled-substances.

Source Summary by GovInfoNow · govinfonow.com/recall/57379-bd-pyxis-cii-safe-es-software-update-risk-controlled-substances · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0093-2024

Cite this page

“BD Pyxis CII Safe ES Software Update Risk: Controlled Substances Diversion.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57379-bd-pyxis-cii-safe-es-software-update-risk-controlled-substances. Based on FDA recall #Z-0093-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0093-2024%22&limit=1).

CareFusion 303, Inc. recalled BD Pyxis CII Safe ES automated dispensing cabinets and related desktop PCs due to a software error that could allow diversion of controlled substances, the FDA said on Sept. 6, 2023.

How to tell if you have it

BD Pyxis CII Safe ES, REF: 1116-00
BD Pyxis : CII Safe ES Desktop PC, Wired SCNR, REF: 107-254-01; CII Safe ES Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01
Enterprise Server, REF: 1115-00, 134157-01, 137670-02, 134148-01, 135292-01, 136449-01, 133760-01; REF: 1116-00
UDI-DI: 10885403512605
Software Versions: 1.7.3 and 1.7.4

The hazard

The FDA reported that when global edit is used to update multiple formulary properties simultaneously, specific settings are overwritten to "NO" without user warning. This error could result in the diversion of controlled substances from the automated dispensing cabinet.

Context

GovInfoNow's records show CareFusion 303, Inc. has 64 other recalls on record since 2017-06-12. Other recent recalls include BD Pyxis MedStation ES REF 323 Medication Cabinet Recall (2026-04-30), CareFusion labeling recall (2026-02-11), and BD Pyxis ES Enterprise Server Software Update Issue Recall (2025-12-03). Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion System Software Recall (2025-11-14), B Braun IV Sets Risk Backflow of Medication - Recall (2025-10-29), and Elekta MOSAIQ Oncology System Recall (2025-12-10).

How to tell if you have this one

Check for software versions 1.7.3 or 1.7.4 on BD Pyxis CII Safe ES systems. Affected units include specific model numbers and reference codes listed in the recall notice.

Brand
BD Pyxis
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Review the software version on your BD Pyxis CII Safe ES system to determine if it is 1.7.3 or 1.7.4.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

FDA distribution: “US Nationwide distribution in the states of LA, NC, NY, MI, MA, NV, KS, IA, CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Iowa, Kansas, Louisiana, Massachusetts, Michigan, Nevada, New York, North Carolina.

Recall timeline

FDA published this recall 42 days after the firm started it.

Sep 6, 2023Firm started the recall
Oct 10, 2023FDA classified it Class II
Oct 18, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/57379-bd-pyxis-cii-safe-es-software-update-risk-controlled-substances">BD Pyxis CII Safe ES Software Update Risk: Controlled Substances Diversion (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0093-2024 (September 6, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0093-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.