Medical DeviceNov 5, 2025
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 recall — FDA Z-0346-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Recall history in this database
Classification mix: Class II: 340, Class I: 20.
Medical DeviceNov 5, 2025
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating recall — FDA Z-0358-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber recall — FDA Z-0359-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 recall — FDA Z-0349-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating recall — FDA Z-0361-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock recall — FDA Z-0340-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 recall — FDA Z-0355-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip recall — FDA Z-0334-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter recall — FDA Z-0360-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 recall — FDA Z-0335-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S recall — FDA Z-0344-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Bag Spike, 01 units REF: CL-10-10 recall — FDA Z-0328-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros recall — FDA Z-0339-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 recall — FDA Z-0345-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceNov 5, 2025
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 recall — FDA Z-0343-2026
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceOct 29, 2025
ICU Medical IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) recall — FDA Z-0154-2026
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over…
Class IFDA: OngoingICU Medical, Inc.
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer recall — FDA Z-2522-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and recall — FDA Z-2526-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit recall — FDA Z-2527-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer recall — FDA Z-2523-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and recall — FDA Z-2525-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
Medical DeviceSep 10, 2025
ICU Medical Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp recall — FDA Z-2524-2025
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication…
Class IIFDA: OngoingICU Medical Inc.
Medical DeviceJul 23, 2025
ICU Medical SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF recall — FDA Z-2116-2025
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol…
Class IIFDA: OngoingICU Medical, Inc.
Medical DeviceJun 25, 2025
ICU Medical Plum Solos, Item number 400011001 recall — FDA Z-1991-2025
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the…
Class IIFDA: OngoingICU 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.