ICU Medical recalls
ICU Medical has 663 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 23 Sep 2026. 132 are still ongoing. 63 were reported in the last 12 months. The most frequent reason is packaging defects.
Total recalls 663 since 2012
Last 12 months 63 reported
Class I 26 4% of total
Ongoing 132 latest 23 Sep 2026
Recalls per month, last 24 months click a bar for that month Severity split
26 4%637 96%0 0%
Why icu medical is recalled
Ongoing icu medical recalls 132 active
All icu medical recalls, newest first 663 total Reported Class Recall Company Reason Where 23 Sep 2026 Device CLASS II CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled ICU Medical Packaging Defects Nationwide 23 Sep 2026 Device CLASS II IV Sets with drip chambers recalled by ICU Medical ICU Medical Particulate Matter Nationwide 23 Sep 2026 Device CLASS II IV Sets with drip chambers recalled by ICU Medical ICU Medical Particulate Matter Nationwide 23 Sep 2026 Device CLASS II IV Non-Dedicated Gravity Administration Sets with drip chambers recalled ICU Medical Foreign Material Nationwide 23 Sep 2026 Device CLASS II IV Sets with drip chambers recalled by ICU Medical ICU Medical Particulate Matter Nationwide 23 Sep 2026 Device CLASS II Plum administration sets recalled by ICU Medical ICU Medical Particulate Matter Nationwide 23 Sep 2026 Device CLASS II IV Sets with drip chambers recalled by ICU Medical ICU Medical Particulate Matter Nationwide 23 Sep 2026 Device CLASS II Oncology sets with drip chambers recalled by ICU Medical ICU Medical Foreign Material Nationwide 23 Sep 2026 Device CLASS II Oncology sets with drip chambers recalled by ICU Medical ICU Medical Foreign Material Nationwide 29 Jul 2026 Device CLASS II Hotline Fluid Warming Set, single use device recalled by ICU Medical ICU Medical Packaging Defects Nationwide 22 Jul 2026 Device CLASS II Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical ICU Medical Other Nationwide 17 Jun 2026 Device CLASS II Plum Solo Precision IV Pump recalled by ICU Medical ICU Medical Device Malfunction Nationwide 17 Jun 2026 Device CLASS II Plum Duo Infusion Pump recalled by ICU Medical ICU Medical Device Malfunction Nationwide 17 Jun 2026 Device CLASS II Plum Duo Precision IV Pump recalled by ICU Medical ICU Medical Device Malfunction Nationwide 27 May 2026 Device CLASS II Oncology Kit w/60" Appx, Smallbore Ext Set w/ChemoLock Port recalled ICU Medical Packaging Defects Nationwide 28 Jan 2026 Device CLASS II Plum Duo Precision IV Pump, List Numbers: 400020403 (US) recalled ICU Medical Other Nationwide 28 Jan 2026 Device CLASS II Plum Solo Precision IV Pump, List Numbers: 400010401 (US) recalled ICU Medical Other Nationwide 28 Jan 2026 Device CLASS II Tego Connector recalled by ICU Medical ICU Medical Packaging Defects Nationwide 28 Jan 2026 Device CLASS II Plum Duo Infusion Pump, List Numbers: 400020401 (US) recalled ICU Medical Other Nationwide 21 Jan 2026 Device CLASS II Plum Duo Infusion System, List Number recalled by ICU Medical ICU Medical Device Malfunction Nationwide 21 Jan 2026 Device CLASS II Portex Spinal Tray recalled by ICU Medical ICU Medical Packaging Defects Nationwide 21 Jan 2026 Device CLASS II Pulsator Arterial Blood Sampling Kit recalled by ICU Medical ICU Medical Packaging Defects Nationwide 31 Dec 2025 Device CLASS II LifeShield Drug Library Management (DLM), LifeShield Infusion Safety recalled ICU Medical Device Malfunction Nationwide 31 Dec 2025 Device CLASS II LifeShield Drug Library Management (DLM) recalled by ICU Medical ICU Medical Device Malfunction Nationwide 5 Nov 2025 Device CLASS II ChemoLock Universal Vented Vial Spike recalled by ICU Medical ICU Medical Packaging Defects Nationwide 5 Nov 2025 Device CLASS II ChemoLock Vented Vial Spike recalled by ICU Medical ICU Medical Packaging Defects Nationwide 5 Nov 2025 Device CLASS II 60" Appx, Ext Set, Smallbore w/ChemoLock Port, Clamp recalled ICU Medical Packaging Defects Nationwide 5 Nov 2025 Device CLASS II ChemoLock Bag Spike recalled by ICU Medical ICU Medical Packaging Defects Nationwide 5 Nov 2025 Device CLASS II ChemoLock Vented Vial Spike recalled by ICU Medical ICU Medical Packaging Defects Nationwide 5 Nov 2025 Device CLASS II ChemoLock Bag Spike with Clave Additive Port recalled by ICU Medical ICU Medical Packaging Defects Nationwide
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About this list
Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.