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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

LifeShield Infusion Safety Software Recalled for Dosing Precision Issue

Agency Publication Date: December 19, 2025
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Summary

ICU Medical, Inc. is recalling LifeShield Drug Library Management (DLM) and LifeShield Infusion Safety Software Suite v2.2 (Product No. 17003-02). Approximately 12 customers are affected by a software defect that only allows concentration limits to be set with one decimal point of precision (0.1) instead of three (0.001). This limitation may force clinicians to set dosing limits that differ from the drug manufacturer's recommendations, potentially leading to incorrect medication delivery.

Risk

The software issue may result in the over-delivery or under-delivery of medications. Incorrect dosing can lead to serious patient harm, including drug toxicity or ineffective treatment, depending on the specific medication being administered.

What You Should Do

  1. This recall affects LifeShield Drug Library Management (DLM) and LifeShield Infusion Safety Software Suite v2.2 (Product No. 17003-02) with UDI-DI 00887709127227.
  2. Stop using the recalled software.
  3. Contact ICU Medical, Inc. or your distributor to arrange for a software correction, replacement, or update.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

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
Model / REF:
17003-02
UDI:
00887709127227

Recall #: Z-0966-2026; Quantity: 12 customers affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98022
Status: Active
Manufacturer: ICU Medical, Inc.
Sold By: Hospital and clinical distributors
Manufactured In: United States
Units Affected: 12 customers
Distributed To: California, Iowa, Kentucky, Louisiana, Maryland, Mississippi, 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.