ICU Medical LifeShield Infusion Safety Software recalled for precision dosing limits
What this means
ICU Medical's LifeShield Infusion Safety Software v2.2 has a software issue that limits concentration settings to one decimal place instead of three. This may force users to set drug limits differently than the manufacturer recommends, potentially causing patients to receive too much or too little medication.
- Contact ICU Medical immediately if your facility uses LifeShield Infusion Safety Software v2.2 (Product No. 17003-02)
- Do not rely on the Concentration Limits feature until you receive corrected software
- Verify all infusion dosages manually against manufacturer guidelines
- Ask ICU Medical about a software update or patch
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2026More ICU Medical recalls
- FDA-Device2026-07-22ICU Medical Plum Solo Precision IV Pump v1.0.3 recalled for potential overdose risk
- FDA-Device2026-07-22ICU Medical Plum Duo Infusion Pump recalled for potential overdose risk
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.