CLASS II ONGOING Device recall · Reported 21 May 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 2 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802

Quantity recalled12 US, 3 OUS

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-1763-2025
FDA event ID: 96771
Recalling firm: ICU Medical, Lake Forest, IL
Classification: Class II
Status: Ongoing
Recall initiated: 2 May 2025
FDA classified: 14 May 2025
Reported: 21 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

2 May 2025	Recall initiated by company
14 May 2025	Classified by FDA	+12 days
21 May 2025	Published in enforcement report	+7 days

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

Reason for recall

Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.

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 v2.1 and v2.2

Where it was distributed

Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.

Nationwide California Florida Iowa Kentucky Louisiana Massachusetts Mississippi New York Pennsylvania Tennessee Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802

Where was it sold?

Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA, MA, MS, NY, PA, TN, and VA. The country of Philippines.

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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