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
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 CaliforniaIowaKentuckyLouisianaMarylandMississippiNew YorkPennsylvaniaTennesseeVirginia
Questions about this recall
Why was it recalled?
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.
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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