CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety recalled

ICU Medical is recalling LifeShield Drug Library Management (DLM), LifeShield Infusion Safety, distributed nationwide in the US. The recall was initiated on 24 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227

Quantity recalled12 customers

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0966-2026
FDA event ID: 98022
Recalling firm: ICU Medical, Lake Forest, IL
Classification: Class II
Status: Ongoing
Recall initiated: 24 Nov 2025
FDA classified: 19 Dec 2025
Reported: 31 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

24 Nov 2025	Recall initiated by company
19 Dec 2025	Classified by FDA	+25 days
31 Dec 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

Where it was distributed

US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.

Nationwide California Iowa Kentucky Louisiana Maryland Mississippi New York Pennsylvania Tennessee Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

LifeShield Infusion Safety Software Suite v2.2 UDI-DI 00887709127227

Where was it sold?

US Nationwide distribution in the states of CA, IA, KY, LA, MD, MS, NY, PA, TN, VA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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