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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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Medium RiskFDA Device
Medical Devices/Monitoring Devices

LifeShield Infusion Safety Software Suite Recalled for Review Option Failure

Agency Publication Date: December 19, 2025
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Summary

ICU Medical, Inc. has issued a recall for LifeShield Drug Library Management (DLM) and LifeShield Infusion Safety Software Suite (v2.2.1) affecting 7 customers. The software's "Change Summary" review option may stop working correctly after a library migration, which could result in medical professionals failing to identify changes in drug settings. If not corrected, this can lead to incorrect medication delivery speeds or delays in setting up infusion pumps for patients.

Risk

The software defect may cause infusion pumps to deliver too much or too little medication, or delay treatment. These medication errors can lead to serious adverse health consequences depending on the drug being administered.

What You Should Do

  1. This recall affects LifeShield Drug Library Management (DLM) and LifeShield Infusion Safety Software Suite v2.2.1 (List Number 17003-02, UDI-DI 00887709127227). It specifically impacts customers who migrated from version 2.1x to version 2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.
  2. Stop using the "Change Summary" review option within the software for any migrated drug libraries.
  3. Use alternate methods provided by ICU Medical to review and verify drug library changes before they are deployed to infusion pumps.
  4. Contact ICU Medical, Inc. or your authorized distributor to arrange for a software correction or to receive updated instructions for managing your drug library migration.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device safety.

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: LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2
Variants: version 2.2.1
Model / REF:
17003-02
UDI:
00887709127227

Issue affects customers who migrated from LifeShield DLM v2.1x to LifeShield DLM v2.2.1 and have any version of a Plum Duo v1.1 drug library that was approved or locked for review before the migration.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98000
Status: Active
Manufacturer: ICU Medical, Inc.
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 7 customers
Distributed To: California, Iowa, Louisiana, New York, Pennsylvania, Tennessee, Virginia

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.