The Recall Desk
HighFDA (Devices)·Z-1223-2024·Announced 2024-03-13

Automated medication dispensing cabinets may randomly freeze, crash, or hang

BD Pyxis automated dispensing cabinets with affected software may randomly hang, freeze, or crash, potentially delaying medication access and causing data loss. Approximately 20,443 units are affected worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. Classified as a risk-of-harm product where injury has not yet been reported, as affected dispensing cabinet software malfunctions are potential rather than known to have caused actual harm.

Plain-English summary

BD Pyxis automated medication dispensing cabinets (MedStation ES REF 323, Anesthesia Station ES REF 327, and MedStation ES Tower REF 352) running software versions 1.4.x, 1.5.x, and 1.6.x are being recalled. These devices are used in healthcare facilities to automatically dispense medications.

The affected cabinets may experience random application hangs, freezes, and crashes. When these malfunctions occur, they can result in delays in accessing medications and potential loss of data.

Approximately 20,443 units have been distributed worldwide, including throughout the United States and internationally to numerous countries. CareFusion 303, Inc., the manufacturer, is handling the recall.

The recalled product

Product
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Dispensing Cabinet
Hazard
Affected units
20,443

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • REF/UDI-DI: 323/10885403512667
  • 327/10885403477836
  • 352/10885403512674. All Using Software Version ES System Release 1.4.x
  • 1.5.x and 1.6.x

Distribution

Distributed nationwide across the United States.

The notice also names 54 states specifically:

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · software malfunction

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