CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report
LifeShield Drug Library Management (DLM) recalled by ICU Medical
ICU Medical is recalling LifeShield Drug Library Management (DLM), 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
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-0965-2026
- FDA event ID
- 98000
- 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
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
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 List Number 17003-02
Where it was distributed
US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
Nationwide CaliforniaIowaLouisianaNew YorkPennsylvaniaTennesseeVirginia
Questions about this recall
Why was it recalled?
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
Which lots are affected?
version 2.2.1 UDI-DI 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.
Where was it sold?
US Nationwide distribution in the states of CA, IA, LA, 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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