ICU Medical Inc
FDA Regulatory Profile
ICU Medical Inc appears in FDA public data with 666 recalls — including 28 Class I (most serious) —, 72 510(k) clearances, 31 FDA inspections, and 4 compliance actions on record. Its most recent recall (Z-3212-2026, Class II) was initiated on August 20, 2026. Its most recent 510(k) clearance was granted on September 18, 2026.
Summary
- Total Recalls
- 666 (28 Class I)
- 510(k) Clearances
- 72
- Inspections
- 31
- Compliance Actions
- 4
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3212-2026 | Class II | CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7 | August 20, 2026 |
| Z-2759-2026 | Class II | Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and d | June 24, 2026 |
| Z-2723-2026 | Class II | ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; | June 10, 2026 |
| Z-2724-2026 | Class II | ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump | June 10, 2026 |
| Z-3162-2026 | Class II | IV Sets with drip chambers | May 12, 2026 |
| Z-3163-2026 | Class II | IV Sets with drip chambers | May 12, 2026 |
| Z-3157-2026 | Class II | IV Non-Dedicated Gravity Administration Sets with drip chambers | May 12, 2026 |
| Z-3161-2026 | Class II | IV Sets with drip chambers | May 12, 2026 |
| Z-3158-2026 | Class II | Oncology sets with drip chambers | May 12, 2026 |
| Z-3156-2026 | Class II | Plum administration sets | May 12, 2026 |
| Z-3160-2026 | Class II | IV Sets with drip chambers | May 12, 2026 |
| Z-3159-2026 | Class II | Oncology sets with drip chambers | May 12, 2026 |
| Z-2313-2026 | Class II | Plum Duo Precision IV Pump, 40002-0403 | April 29, 2026 |
| Z-2311-2026 | Class II | Plum Solo Precision IV Pump, 40001-0401 | April 29, 2026 |
| Z-2312-2026 | Class II | Plum Duo Infusion Pump, 40002-0401 | April 29, 2026 |
| Z-2210-2026 | Class II | Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valv | March 24, 2026 |
| Z-1111-2026 | Class II | Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 | December 19, 2025 |
| Z-1100-2026 | Class II | Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG | December 19, 2025 |
| Z-1101-2026 | Class II | Portex Spinal Tray, Item No. A3729-24 A3595 | December 19, 2025 |
| Z-1120-2026 | Class II | ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) | December 15, 2025 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K262532 | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | September 18, 2026 |
| K252130 | LifeShield Infusion Safety Software Suite | April 2, 2026 |
| K252006 | OTTO Disinfecting Cap | March 27, 2026 |
| K251980 | ClaveQS Bag | March 20, 2026 |
| K250616 | Clave Neutral-Displacement Needlefree Connectors | June 5, 2025 |
| K242117 | LifeShield Infusion Safety Software Suite | April 2, 2025 |
| K242115 | Plum Duo Precision IV Pump | April 2, 2025 |
| K242114 | Plum Solo Precision IV Pump | April 2, 2025 |
| K243985 | Rio Drug Reconstitution Transfer Device | January 22, 2025 |
| K232048 | Cogent Hemodynamic Monitoring System; Cogent HMS | December 20, 2023 |
| K223606 | LifeShield Infusion Safety Software Suite | August 24, 2023 |
| K223607 | Plum Duo Infusion System | August 24, 2023 |
| K192154 | Rio Vial-to-Bag Drug Reconstitution Device | April 20, 2020 |
| K190918 | SwabTip Male Disinfectant Cap | March 6, 2020 |
| K190157 | Diana ChemoClave Transfer Set | October 23, 2019 |
| K173477 | ChemoCLAVE Cytotoxic Medication Preparation and Delivery System | August 31, 2018 |
| K170110 | Diana Medication Transfer Set | August 10, 2018 |
| K171346 | Sapphire Sets | August 25, 2017 |
| K152006 | Cogent Hemodynamic Monitoring System | May 5, 2016 |
| K151969 | Hospira Extension Sets | January 19, 2016 |