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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

BD Alaris Infusion Pump Modules Recalled for Impact-Related Damage Risk

Agency Publication Date: November 20, 2025
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Summary

CareFusion 303 (BD) is recalling 2,574,396 Alaris Infusion Pump Modules and replacement bezel kits because dropping or severely jarring the units can damage the bezel assembly. This damage can cause the pump to deliver too much or too little medication, allow unregulated flow, or fail to calibrate correctly. Affected units include those distributed since June 19, 2004, and users are advised to remove any impacted pumps from service for professional inspection.

Risk

A damaged bezel assembly can lead to inaccurate medication delivery, which poses a significant risk of patient injury or death. Physical impacts can compromise the pump's structural integrity, resulting in the device failing to regulate fluid flow or providing incorrect dosages.

What You Should Do

  1. This recall affects BD Alaris Infusion Pump Modules (Model 8100) and replacement bezel kits (Model 49000437 and 49000270) distributed after June 19, 2004.
  2. Immediately remove any pump module from clinical use if it has been dropped or severely jarred, even if there is no visible damage to the exterior.
  3. Submit any dropped or jarred pumps to qualified service personnel for testing and inspection before returning the device to service.
  4. Ensure all staff review the updated 'BD Alaris Infusion System Inspection Safety Reminder' and the revised 'Cleaning and Disinfecting Procedure' and 'Quick Reference Guide'.
  5. Contact CareFusion 303, Inc. (BD) directly to arrange for return, replacement, or correction of the recalled components.
  6. Call the FDA: 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD Alaris infusion Pump Module 8100
Model / REF:
8100
UDI:
10885403810015
10885403810046
10885403810039
10885403222054
10885403517723
10885403213212
10885403211423
Date Ranges: Distributed after June 19, 2004

Used with BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864

Product: KIT, BEZEL ASSY 8100BD
Model / REF:
49000437
UDI:
10885403471018
Product: KIT ASSY ONE PIECE BEZEL 8100
Model / REF:
49000270
UDI:
10885403247743

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97669
Status: Active
Manufacturer: CareFusion 303, Inc.
Manufactured In: United States
Units Affected: 2,574,396
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.