The Recall Desk
HighFDA (Devices)·Z-1639-2025·Announced 2025-04-30

Automated Dispensing Cabinet Software Bug Causes Double Inventory Quantities

BD PYXIS automated dispensing cabinets have a software bug that can double bin quantities during restocking, potentially delaying medication access.

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: This is an FDA Class II recall of an automated medication dispensing system with a software defect that can cause medication access delays. No injuries or illnesses have been reported. The hazard is classified as High because it presents a risk of harm to patients through delayed medication access, though no adverse events have occurred.

Plain-English summary

BD PYXIS MEDBANK and MEDFLEX automated medication dispensing cabinets are subject to this recall. The affected systems include various MEDBANK Mini and Tower configurations and MEDFLEX models. Approximately 7,357 units have been distributed nationwide.

During the pocket exchange restocking workflow, a software issue can occur when users restock a single bin location. The system processes 2 destock transactions and 2 stock transactions instead of the correct number of transactions, causing the bin quantity to double.

The inventory doubling may result in delayed access to medications and supplies. Such delays could lead to temporary impairment of body function. No injuries or adverse events have been reported in connection with this issue.

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 — Medication Dispensing Cabinet
Hazard
  • software-defect
  • medication-access-delay
  • inventory-error

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.

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