CLASS II ONGOING Device recall · Reported 19 Feb 2025 · FDA Enforcement Report

BD Pyxis MedStation ES recalled by CareFusion 303

CareFusion 303 is recalling BD 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

Lot, batch or date codes(1)BD Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) BD Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; ALL serial numbers; software versions v1.10 and prior. (4) BD Pyxis MedStation 4000 Console, Catalog No. 309, All serial numbers and all software versions, UDI-DI: 10885403512636; (5) BD Pyxis MedStation 4000, Catalog No. 303, All serial numbers and all software versions, UDI-DI: 10885403512629 (HW), 10885403513787 (SW); (6) BD Pyxis Anesthesia System 4000, Catalog No. 338, All serial numbers and all software versions, UDI-DI: 10885403477829 (HW), 10885403513787 (SW)

Quantity recalled193067

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-1120-2025
FDA event ID: 96056
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: Other Reasons
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

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

Product as listed by the FDA

(1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327; (3) BD Pyxis MedStation ES Tower, Catalog No. 352; (4) BD Pyxis MedStation 4000 Console, Catalog No. 309; (5) BD Pyxis MedStation 4000, Catalog No. 303; (6) BD Pyxis Anesthesia System 4000, Catalog No. 338

Where it was distributed

Domestic distribution nationwide US. International distribution to North America, Latin America, EMEA, and Greater Asia.

Nationwide

Questions about this recall

Is BD Pyxis MedStation ES recalled?

Yes. CareFusion 303 recalled BD Pyxis MedStation ES on 8 Jan 2025. The recall is Class II and its status is Ongoing. Recall number Z-1120-2025.

Why was it recalled?

Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.

Which lots are affected?

(1)BD Pyxis MedStation ES, Catalog No. 323, UDI-DI 10885403512667; (2) BD Pyxis Anesthesia Station (PAS), Catalog No. 327, UDI-DI 10885403477836; (3) BD Pyxis MedStation ES Tower, Catalog No. 352, UDI-DI 10885403512674; ALL serial numbers; software versions v1.10 and prior. (4) BD Pyxis MedStation 4000 Console, Catalog No. 309, All serial numbers and all software versions, UDI-DI: 10885403512636; (5) BD Pyxis MedStation 4000, Catalog No. 303, All serial numbers and all software versions, UDI-DI: 10885403512629 (HW), 10885403513787 (SW); (6) BD Pyxis Anesthesia System 4000, Catalog No. 338, All serial numbers and all software versions, UDI-DI: 10885403477829 (HW), 10885403513787 (SW)

Where was it sold?

Domestic distribution nationwide US. 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

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Reported	Class	Recall	Company	Reason	Where
10 Jun 2026Device	CLASS II	BD Pyxis MedStation ES Tower recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	BD Pyxis MedBank Mini recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	BD Pyxis MedStation recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	BD Pyxis Anesthesia Station ES recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide
10 Jun 2026Device	CLASS II	BD Pyxis MedStation ES recalled by CareFusion 303	CareFusion 303	Temperature Abuse	Nationwide

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