The Recall Desk
HighFDA (Devices)·Z-0368-2026·Announced 2025-11-05

Medication dispensing stations recalled over fluid ingress causing smoke or fire

CareFusion is recalling 2,755 BD Pyxis MedFlex units because potential fluid ingress of the anesthesia or med station may result in smoke, system downtime and/or fire.

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: Scored 3 under the risk-of-harm criterion: fluid ingress that may cause smoke or fire in a clinical dispensing unit is a hazard, and no injuries are reported.

Plain-English summary

Various models of BD Pyxis MedFlex are being recalled, covering reference numbers including 1119-00, 1139-00 and the 139038-01 through 139058-01 series.

Potential fluid ingress of the anesthesia station or med station may result in smoke, system downtime and/or fire.

The recall covers 2,755 units across all serial numbers, distributed worldwide including nationwide in the United States and to Canada, the United Arab Emirates and Australia. The FDA has classified the action as Class II.

The enforcement record describes the failure mode and reports no injuries. Facilities operating affected units should follow the firm's instructions.

The recalled product

Product
Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-0
Manufacturer
CareFusion 303, Inc.
Category
Medical Device — Medication dispensing
Hazard
Affected units
2,755

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)

  • All Serial Numbers/Ref #/UDI: 1119-00 10885403512704
  • 1139-00 10885403512704
  • 139038-01 N/A
  • 139039-01 N/A
  • 139040-01 N/A
  • 139041-01 N/A
  • 139043-01 N/A
  • 139044-01 N/A
  • 139045-01 N/A
  • 139046-01 N/A
  • 139049-01 N/A
  • 139051-01 N/A
  • 139052-01 N/A
  • 139053-01 N/A
  • 139054-01 N/A
  • 139055-01 N/A
  • 139056-01 N/A
  • 139058-01 N/A
  • 139059-01 N/A
  • 139060-01 N/A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · fluid ingress

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