CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report
Pyxis MedStation ES recalled by CareFusion 303
CareFusion 303 is recalling Pyxis MedStation ES, distributed nationwide in the US. The recall was initiated on 8 Jan 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1119-2025
- FDA event ID
- 96055
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jan 2025
- FDA classified
- 7 Feb 2025
- Reported
- 19 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 8 Jan 2025 | Recall initiated by company | |
| 7 Feb 2025 | Classified by FDA | +30 days |
| 19 Feb 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00
Where it was distributed
Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
Questions about this recall
Is Pyxis MedStation ES recalled?
Yes. CareFusion 303 recalled Pyxis MedStation ES on 8 Jan 2025. The recall is Class II and its status is Ongoing. Recall number Z-1119-2025.
Why was it recalled?
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
Which lots are affected?
(1) Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; (4) BD Pyxis CII Safe ES, Catalog No. 1116-00, UDI-DI 10885403512605; All Serial Numbers; Software Versions v1.10 and prior Affected
Where was it sold?
Domestic distribution nationwide. International distribution to North America, Latin America, EMEA, and Greater Asia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from CareFusion 303
All 143| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BD Pyxis MedStation ES Tower recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedBank Mini recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedStation recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis Anesthesia Station ES recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedStation ES recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
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