Medical Device Dec 31, 2025
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…
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Medical Device Nov 5, 2025
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II FDA: Ongoing ICU Medical, Inc.
Understanding this recall history This page summarizes recall records in which the official source identifies ICU Medical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.