The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1639-2025·Announced 2025-04-30

BD PYXIS MEDBANK Automated Dispensing Cabinet Software Defect

CareFusion's BD PYXIS MEDBANK and MEDFLEX automated dispensing cabinets may experience a software issue during bin restocking that doubles bin quantities, potentially delaying access to medications and supplies.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall involving a risk-of-harm medical device (potential delay in medication access) where no illnesses or injuries have been reported. The source text describes only a theoretical risk—"may result in a delay" and "may lead to temporary body function impairment"—without documented adverse events, placing it at High per the rubric.

Plain-English summary

CareFusion 303, Inc. is recalling BD PYXIS MEDBANK and BD PYXIS MEDFLEX automated dispensing cabinets due to a software issue affecting the restocking workflow. When users attempt to restock a single bin location, the system may execute 2 destock transactions and 2 stock transactions instead of the intended single transaction pair, resulting in the bin quantity being doubled.

This software defect may result in a delay in access to desired medications and supplies. The affected devices have been distributed nationwide across the United States. The recall affects approximately 7,357 units across multiple models and configurations, including MEDBANK MINI, MEDBANK TOWER, MEDFLEX, and related variants.

Users of affected devices should contact CareFusion for guidance on remediation. The FDA classified this recall as Class II.

The recalled product

Product
BD PYXIS MEDBANK (Name, REF): MEDPASS MODULE, 139088-01; MINI 1FH-1FM, 169-137; MINI 1HH-1FH-1HM, 169-101; MINI 1HH-1HM-1FM, 169-102; MINI 2FH, 138902-01; MINI 2FH, 169-104; MINI 2FM, 169-105; MINI 2HH-1FH, 169-106; MINI 2HH-1FH, 138908-01; MINI 2HH-1FM, 169-107; MINI…
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Automated Dispensing Cabinet
Hazard
Affected units
7,357

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: 139088-01/1.2.3.23
  • 169-137/10885403512544/2.4
  • 169-101/10885403512544/2.4
  • 169-102/10885403512544/2.4
  • 138902-01/2.4
  • 169-104/10885403512544/2.4
  • 169-105/10885403512544/2.4
  • 169-106/10885403512544/2.4
  • 138908-01/2.4
  • 169-107/10885403512544/2.4
  • 138906-01/2.4
  • 169-108/10885403512544/2.4
  • 169-110/10885403512544/2.4
  • 139091-01/2.4
  • 169-111/10885403512544/2.4
  • 138910-01/2.4
  • 169-112/10885403512544/2.4
  • 169-113/10885403512544/2.4
  • 138915-01/2.4
  • 169-23/10885403512568/2.4

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

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