Agency classClass IIOur severity:High FDA (Devices)·Z-1206-2025·Announced 2025-03-05

BD Pyxis Medication Dispensing Devices Labeling Update Addresses Manual Access Risk

FDA is requiring labeling updates for BD Pyxis automated medication dispensing devices to address the risk of delays in medication access due to power loss or device malfunctions. The recall affects approximately 1,521 units distributed nationwide.

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: Class II recall addressing potential delays in medication access from power loss or device malfunction. No injuries or illnesses reported. This qualifies as a risk-of-harm medical device without reported injury, meeting the High (3) severity criterion.

Plain-English summary

BD Pyxis MedFlex (REF 1119-00), MedBank Tower (REF 1145-00), and MedBank MedPass (REF 139088-01) automated medication dispensing devices, along with associated user guides and quick reference guides, are subject to a labeling update.

The FDA is requiring strengthened labeling regarding manual access to medications. The update addresses the risk of potential delays in retrieving or accessing medications that may result from power loss or automated dispensing device malfunctions.

Approximately 1,521 units have been distributed nationwide to healthcare facilities across the United States.

Healthcare facilities using these devices should review the updated labeling and user guides to understand manual medication access procedures in case of power loss or device malfunction.

The recalled product

Product: BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass, REF: 139088-01 and associated BD Pyxis user/software/safety guides and quick reference guides.
Manufacturer: CareFusion 303, Inc.
Category: Medical Device — Medication dispensing system
Hazard: medication-access-delay
power-loss
device-malfunction
Affected units: 1,521

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)

13523350
13754724
13767953
13789575
13801727
13826187
13879544
13883357
13884848
13934472
13939327
13948724
14032802
14037891
14158187
14159916
14168580
14172832
14175162
14182716

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Same manufacturer · CareFusion 303, Inc.

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