The Recall Desk
HighFDA (Devices)·Z-1545-2025·Announced 2025-04-16

[pending] BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass

Pending LLM rewrite. Source: FDA_DEVICE Z-1545-2025.

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: Pending LLM scoring against the rubric.

Plain-English summary

Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.

The recalled product

Product
BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower, BD Pyxis" MedFlex, BD Pyxis" MedBank" MedPass are automated dispensing cabinets (ADC) intended to securely store and dispense medications to a qualified and authorized user in a clinical settings.
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Devices

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 (20)

  • REF/UDI-DI(GTIN)/Software Version: 169-143/10885403512568/2.4
  • 169-145/10885403512568/2.4
  • 169-144/10885403512568/2.4
  • 169-142/10885403512568/2.4
  • 139088-01/1.2.3.23
  • 155288-01/10885403508721/2.4
  • 169-137/10885403512544/2.4
  • 155311-01/10885403510847/2.4
  • 169-151/10885403512544/1.2.3.23
  • 138921-01/2.4
  • 155159-01/10885403504655/2.4
  • 169-101/10885403512544/2.4
  • 139122-01/2.4
  • 155160-01/10885403504662/2.4
  • 169-102/10885403512544/2.4
  • 138912-01/2.4
  • 155161-01/10885403504679/2.4
  • 169-103/10885403512544/2.4
  • 138902-01/2.4
  • 169-104/10885403512544/2.4

Distribution

Distributed nationwide across the United States.

Related recalls

Same category