LifeShield Infusion Safety Software Recalled for Drug Library Defects
ICU Medical is recalling LifeShield Drug Library Management software v2.1 and v2.2 due to defects that could allow over-delivery of medication to patients or unauthorized modification of drug parameters.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II medical device recall involving software defects that could result in medication over-delivery or unauthorized modifications affecting patient therapy parameters. The defects create a risk of serious harm to patients even though no reported illnesses or injuries are stated in the source text.
Plain-English summary
ICU Medical, Inc. is recalling LifeShield Drug Library Management (DLM) and LifeShield Infusion Safety Software Suite v2.1 and v2.2. The software has been distributed worldwide, including to 12 facilities in the United States (in the states of California, Florida, Iowa, Kentucky, Louisiana, Massachusetts, Mississippi, New York, Pennsylvania, Tennessee, and Virginia) and 3 locations outside the United States (including the Philippines).
The company has identified two software defects in the Drug Library Management system. First, the DLM software does not allow users to create percentage dose rate or rate change values with certain limits, which could potentially result in over-delivery of medication to patients. Second, an unauthorized user may be able to modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
Facilities using this software should contact ICU Medical, Inc. for information about updates or remediation. Healthcare providers should review their drug library settings and access controls to ensure patient safety.
The recalled product
- Product
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
- Manufacturer
- ICU Medical, Inc.
- Hazard
- medication-overdose
- unauthorized-access
- software-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- LifeShield Infusion Safety Software Suite v2.1 and v2.2 UDI-DI 00887709122802
Distribution
Distributed nationwide across the United States.
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