CareFusion 303 recalled 2,079 BD Pyxis ES Enterprise Servers on December 3, 2025 due to a software issue affecting timely updates. The recall impacts devices sold worldwide, including the U.S. and Canada. Patients and healthcare providers must stop using the devices immediately.
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact CareFusion 303, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recall involves BD Pyxis ES Enterprise Servers with catalog numbers including 1115-00, 137670-02, and 139675-01. These servers operate software versions 1.6.1 to 1.11.0 and server application versions ES 5.4X to 5.8.X. They were distributed worldwide, with specific distribution in all U.S. states.
A software issue may result in the equipment not receiving timely updates of patient and medication information. This delay could lead to serious medication errors, impacting patient safety.
No specific incidents or injuries have been reported related to this recall. However, the risk of medication errors due to the software malfunction is classified as high.
Stop using the device immediately. Follow the recall instructions provided by CareFusion 303, Inc. Contact your healthcare provider for further instructions on managing the situation.
For assistance, call CareFusion 303, Inc. at 1-800-XXX-XXXX. More information is available on the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1028-2026.
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