ICU Medical, Inc. 2025-12-31 Health serious FDA
Health · FDA · Recall #FDA-Z-0965-2026
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2… Recall
Issued December 31, 2025 · ICU Medical, Inc.
In December 2025, ICU Medical, Inc. recalled the LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ICU Medical, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- ICU Medical, Inc.
- Category
- Health
- Recall date
- December 31, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of CA, IA, LA, NY, PA, TN, VA.
- Recall number
- FDA-Z-0965-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- ICU Medical, Inc. has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.