Lower riskMedical device recall · FDA · Published January 8, 2025
CareFusion Pyxis Medical Devices: Software Issues May Cause Wrong Therapy or Delays
CareFusion recalls Pyxis MedStation ES and Anesthesia Station models with software issues that could cause wrong therapy doses, delays in dispensing, or unauthorized access. Affected units have specific catalog numbers and software versions.
“CareFusion Pyxis Medical Devices: Software Issues May Cause Wrong Therapy or Delays.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53141-carefusion-pyxis-medical-devices-software-issues-may-cause-wrong-therapy. Based on FDA recall #Z-1119-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1119-2025%22&limit=1).
The FDA announced on Jan. 8, 2025, that CareFusion 303, Inc. is recalling Pyxis MedStation ES and Pyxis Anesthesia Station devices due to software issues that could cause delays in accessing dispensing applications, wrong therapy, or unauthorized access.
How to tell if you have it
Pyxis MedStation ES, Catalog No. 323
Pyxis Anesthesia Station (PAS), Catalog No. 327
Pyxis MedStation ES Tower, Catalog No. 352
BD Pyxis CII Safe ES, Catalog No. 1116-00
The hazard
According to the FDA, software issues could potentially result in delays in accessing dispensing software applications, wrong therapy such as incorrect dose, item, or timing, or unauthorized access and/or compliance related issues.
Context
GovInfoNow's records show CareFusion 303, Inc. has had 64 other recalls on record since June 12, 2017. Other recent recalls of similar products include the BD Pyxis MedBank Tower 1145-00 recall (April 30, 2026), the CareFusion TLS labeling recall (Feb. 11, 2026), and the BD Pyxis ES Enterprise Server Software Update Issue Recall (Dec. 3, 2025).
How to tell if you have this one
Check for Pyxis MedStation ES (Catalog No. 323), Pyxis Anesthesia Station (PAS) (Catalog No. 327), or Pyxis MedStation ES Tower (Catalog No. 352). Also look for software versions v1.10 or earlier. The device may have a unique identifier (UDI-DI) listed in the recall details.
Brand
CareFusion
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your device; affected units have v1.10 or earlier.
Contact CareFusion
Reach out to CareFusion directly for assistance with the recall process.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1119-2025 (January 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1119-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.