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BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXI...

FDA Device Recall #Z-2256-2024 — Class II — May 13, 2024

Recall Summary

Recall Number Z-2256-2024
Classification Class II — Moderate risk
Date Initiated May 13, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm CareFusion 303, Inc.
Location San Diego, CA
Product Type Devices
Quantity 3002

Product Description

BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR MN 4FH-4HH-1FM MP/ 169-142, BD PYXIS MB TWR RXNOW MAIN W/MED PRINTER / 169-155, BD PYXIS MB TWR RXNOW MAIN W/PAT PRINTER/ 169-156, BD PYXIS MDBANK TWR MN 7HH-1HM-3FM/ 169-132, BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow/ 169-131, BD PYXIS MEDBANK TWR MN 10HH-1FH-1FM/ 169-23, BD PYXIS MEDBANK TWR MN 10HH-2FH/ 169-24, BD PYXIS MEDBANK TWR MN 10HH-2FM/ 169-25, BD PYXIS MEDBANK TWR MN 12HH-1FF/ 169-26, BD PYXIS MEDBANK TWR MN 12HH-1FH/ 169-27, BD PYXIS MEDBANK TWR MN 12HH-1FM/ 169-28, BD PYXIS MEDBANK TWR MN 14HH/ 169-29, BD PYXIS MEDBANK TWR MN 1FH-10HM-1FM/ 169-138, BD PYXIS MEDBANK TWR MN 1HH-1HM-2FM-4FF/ 169-30, BD PYXIS MEDBANK TWR MN 2FH-2HM-4FM/ 169-31, BD PYXIS MEDBANK TWR MN 2HH-10HM-1FM/ 169-32, BD PYXIS MEDBANK TWR MN 2HH-1FH-5FM/ 169-33, BD PYXIS MEDBANK TWR MN 2HH-2FH-4FM/ 169-34, BD PYXIS MEDBANK TWR MN 2HH-2FM-4FF/ 169-35, BD PYXIS MEDBANK TWR MN 2HH-4FH-2FM/ 169-139, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FF/ 169-36, BD PYXIS MEDBANK TWR MN 2HH-4HM-4FM/ 169-37, BD PYXIS MEDBANK TWR MN 2HH-6FM/ 169-38, BD PYXIS MEDBANK TWR MN 2HH-6HM-3FM/ 169-39, BD PYXIS MEDBANK TWR MN 2HH-8HM-2FM/ 169-40, BD PYXIS MEDBANK TWR MN 2HM-6FM/ 169-41, BD PYXIS MEDBANK TWR MN 3FH-4FM/ 169-42, BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS/ 169-140, BD PYXIS MEDBANK TWR MN 3HH-7HM-2FM/ 169-43, BD PYXIS MEDBANK TWR MN 4HH-10HM/ 169-44, BD PYXIS MEDBANK TWR MN 4HH-1FH-2HM-3FM/ 169-45, BD PYXIS MEDBANK TWR MN 4HH-1FH-4FM/ 169-46, BD PYXIS MEDBANK TWR MN 4HH-1FH-4HM-2FM/ 169-47, BD PYXIS MEDBANK TWR MN 4HH-1FH-6HM-1FM/ 169-48, BD PYXIS MEDBANK TWR MN 4HH-2FH-2HM-2FM/ 169-49, BD PYXIS MEDBANK TWR MN 4HH-2FH-3FM/ 169-50, BD PYXIS MEDBANK TWR MN 4HH-2HM-4FM/ 169-51, BD PYXIS MEDBANK TWR MN 4HH-3FH-2FM/ 169-52, BD PYXIS MEDBANK TWR MN 4HH-4FH-1FM/ 169-53, BD PYXIS MEDBANK TWR MN 4HH-4HM-3FM/ 169-54, BD PYXIS MEDBANK TWR MN 4HH-5FH / 169-55, BD PYXIS MEDBANK TWR MN 4HH-5FM/ 169-56, BD PYXIS MEDBANK TWR MN 4HH-6HM-2FM/ 169-57, BD PYXIS MEDBANK TWR MN 4HH-8HM-1FM/ 169-58, BD PYXIS MEDBANK TWR MN 4HM-5FM/ 169-59, BD PYXIS MEDBANK TWR MN 5HH-3HM-3FM/ 169-60, BD PYXIS MEDBANK TWR MN 5HH-9HM/ 169-61, BD PYXIS MEDBANK TWR MN 6FH-1FM/ 169-62, BD PYXIS MEDBANK TWR MN 6HH-1FH-2HM-2FM/ 169-63, BD PYXIS MEDBANK TWR MN 6HH-1FH-3FM/ 169-64, BD PYXIS MEDBANK TWR MN 6HH-2FH-2FM/ 169-65, BD PYXIS MEDBANK TWR MN 6HH-2FH-2HM-1FM/ 169-66, BD PYXIS MEDBANK TWR MN 6HH-4FH / 169-67, BD PYXIS MEDBANK TWR MN 6HH-4FM/ 169-68, BD PYXIS MEDBANK TWR MN 6HH-4HM-2FM/ 169-69, BD PYXIS MEDBANK TWR MN 6HH-6HM-1FM/ 169-70, BD PYXIS MEDBANK TWR MN 6HH-8HM/ 169-71, BD PYXIS MEDBANK TWR MN 7FH/ 169-72, BD PYXIS MEDBANK TWR MN 7FM/ 169-73, BD PYXIS MEDBANK TWR MN 7HH-1HM-3FM/ 169-74, BD PYXIS MEDBANK TWR MN 8HH-1FH-2FM/ 169-75, BD PYXIS MEDBANK TWR MN 8HH-1FH-2HM-1FM/ 169-76, BD PYXIS MEDBANK TWR MN 8HH-2FH-1FM/ 169-77, BD PYXIS MEDBANK TWR MN 8HH-2HM-2FM/ 169-78, BD PYXIS MEDBANK TWR MN 8HH-3FF/ 169-79, BD PYXIS MEDBANK TWR MN 8HH-3FH/ 169-80, BD PYXIS MEDBANK TWR MN 8HH-3FM/ 169-81, BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P/ 169-82, BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P/ 169-83, BD PYXIS MEDBANK TWR MN CR-12HH-1FH/ 169-84, BD PYXIS MEDBANK TWR MN CR-12HH-1FM-P/ 169-85, BD PYXIS MEDBANK TWR MN CR-14HH-P/ 169-86, BD PYXIS MEDBANK TWR MN CR-2HH-1FH-5FM/ 169-87, BD PYXIS MEDBANK TWR MN CR-2HH-6FH/ 169-88, BD PYXIS MEDBANK TWR MN CR-2HH-6FM/ 169-89, BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P/ 169-90, BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P/ 169-91, BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P/ 169-92, BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P/ 169-93, BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P/ 169-94, BD PYXIS MEDBANK TWR MN CR-6HH-8HM-P/ 169-95, BD PYXIS MEDBANK TWR MN CR-8HH-1FH-2FM-P/ 169-96, BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P/ 169-97, BD

Reason for Recall

Multiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical Commission (IEC) electrical standards when used as a system with automated dispensing cabinet devices, so use may expose user to leakage currents that could cause varying degrees of harm from a minor shock to permanent impairment.

Distribution Pattern

US Nationwide distribution including in the states of NY, CA, MO, AZ, CO, KS, IL, FL, OK, OH, TN, GA, NM, NV, NE, TX, NC, KY, WI, SC, IA, MT, SD, VA, NJ, PA, AK, MS, MI, WA, UT, ND, MA, MN, OR, IN, WV, AL, ID, LA, CT, WY, MD, NH, AR, HI, DC.

Lot / Code Information

UDI-DI: 10885403512568. Devices Manufactured November 15, 2012 - July, 25 2023 User Guide, DIR 10000414989/DIR 10000414987/DIR 10000414990, Version 00.

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Z-1645-2026 Class II BD Alaris" System with Guardrails" Suite MX wit... Feb 11, 2026
Z-1028-2026 Class II BD Pyxis ES Enterprise Server Catalog Numbers 1... Dec 3, 2025
Z-0962-2026 Class II BD Pyxis MedStation ES, REF: 323, BD Pyxis M... Nov 20, 2025
Z-1217-2026 Class II BD Alaris" Pump Module model 8100 UDI-DI code:... Nov 6, 2025
Z-0430-2026 Class I BD Alaris infusion Pump Module 8100, REF: 8100;... Oct 17, 2025

Frequently Asked Questions

Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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