Infusion Safety Software Recalled Due to Dosing and Security Vulnerabilities
ICU Medical has recalled LifeShield Drug Library Management software (versions 2.1 and 2.2) due to two defects: the software may not properly limit medication dose rates, potentially causing over-delivery, and unauthorized users may modify therapy parameters without approval.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall with potential for significant patient harm from medication over-delivery and unauthorized modification of therapy parameters. No illnesses or injuries are reported in the source material. Per the rubric, risk-of-harm products without reported injuries are scored as High (3).
Plain-English summary
ICU Medical, Inc. has recalled LifeShield Drug Library Management (DLM) software, versions 2.1 and 2.2, a medical device used to manage drug library information for intravenous therapy delivery systems.
The recall addresses two defects identified in the software. First, the software does not properly allow users to create percentage dose rate or rate change values with certain limits, potentially resulting in medication over-delivery to patients. Second, the software has a security vulnerability that allows unauthorized users to modify and approve drug library entries, potentially leading to incorrect program parameters being used for therapy.
The affected software was distributed to 12 facilities in the United States and 3 facilities outside the United States. The U.S. distribution includes California, Florida, Iowa, Kentucky, Louisiana, Massachusetts, Mississippi, New York, Pennsylvania, Tennessee, and Virginia; international distribution includes the Philippines.
This is a Class II medical device recall issued by the FDA.
The recalled product
- Product
- LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
- Manufacturer
- ICU Medical, Inc.
- Hazard
- dosage-error
- unauthorized-access
- incorrect-therapy-parameters
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.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03