The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0973-2025·Announced 2025-01-29

BD Pyxis MedStation 4000 Medication Dispenser Recalled for Door Failures

BD Pyxis MedStation 4000 medication dispensers are recalled due to drawer and door failures that may delay medication access. The recall affects 13,055 units distributed worldwide.

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 a Class II FDA recall of a risk-of-harm product (medication dispensing system) with no reported illnesses or injuries. Mechanical failures that delay access to medications in healthcare settings present potential for significant patient harm.

Plain-English summary

BD Pyxis MedStation 4000 Main medication dispensers have been recalled due to drawer and/or door failures. The device is a medication dispensing system manufactured by CareFusion 303, Inc.

The recall involves three identified failure modes: door latch failure, cable ribbon damage, and magnet falling out. These failures may lead to a delay in access to medications. The recall affects 13,055 units distributed worldwide.

The FDA classified this as a Class II recall. Healthcare facilities and medication management personnel using affected units should be aware of the potential for these mechanical failures.

The recalled product

Product
BD Pyxis MedStation 4000 Main, REF 303
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication dispensing system
Hazard
Affected units
13,055

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)

  • UDI/DI 10885403512629
  • Serial Numbers: 12439536
  • 12439538
  • 12439539
  • 12439540
  • 12439541
  • 12439544
  • 12440786
  • 12440787
  • 12440788
  • 12440789
  • 12440790
  • 12440791
  • 12440792
  • 12440978
  • 12440979
  • 12441431
  • 12443165
  • 12446066
  • 12448071

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by CareFusion 303, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · door latch failure

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