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RecallWatchMedical Device Safety
Class IIOngoingZ-0368-2026

CareFusion 303, Inc. recalls Various models of BD Pyxis MedFlex

CareFusion 303, Inc.San Diego, CA, United StatesReported Nov 5, 2025 · 8 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01 139069-01 139070-01 139071-01 139072-01 139164-01 139165-01300
    UDI 1119-00
    35 affected lots
    1119-00108854035127041139-0010885403512704139038-01139039-01139040-01139041-01
    +27 more139043-01139044-01139045-01139046-01139049-01139051-01139052-01139053-01139054-01139055-01139056-01139058-01139059-01139060-01139061-01139064-01139065-01139066-01139067-01139068-01139069-01139070-01139071-01139072-01139164-01139165-01300

What the firm is doing

On September 30, 2025, BD issue a Urgent Medical Device Recall Expansion notification to affected consignees via FedEx. BD is asking consignees to take the following actions: 1. Affected products can continue to be used per existing Manuals and Guides. 2. In the event of an accidental fluid spill on the device or in a drawer, users should following instructions outlined within the customer notification. 3. Review the customer letter attachment which provides warnings, cautions and recommendations regarding fluid ingress. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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