ICU Medical, Inc.: 242 recalls on record

Recalls filed with 1 agency: FDA (242).

First recall on record: August 8, 2012. Most recent: September 23, 2026.

Risk classification: Class I: 15 · Class II: 227

Most recent recalls

DateAgencyProduct
September 23, 2026FDAPlum administration setsZ-3156-2026
September 23, 2026FDAIV Sets with drip chambersZ-3162-2026
September 23, 2026FDAOncology sets with drip chambersZ-3159-2026
September 23, 2026FDAIV Sets with drip chambersZ-3160-2026
September 23, 2026FDAIV Non-Dedicated Gravity Administration Sets with drip chambersZ-3157-2026
September 23, 2026FDAIV Sets with drip chambersZ-3161-2026
September 23, 2026FDAOncology sets with drip chambersZ-3158-2026
September 23, 2026FDAIV Sets with drip chambersZ-3163-2026
September 23, 2026FDACADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-76…Z-3212-2026
July 29, 2026FDAHotline Fluid Warming Set, single use device, is designed to warm blood and intravenous f…Z-2759-2026
July 22, 2026FDAICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pumpZ-2724-2026
July 22, 2026FDAICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number…Z-2723-2026
June 17, 2026FDAPlum Duo Precision IV Pump, 40002-0403Z-2313-2026
June 17, 2026FDAPlum Solo Precision IV Pump, 40001-0401Z-2311-2026
June 17, 2026FDAPlum Duo Infusion Pump, 40002-0401Z-2312-2026
May 27, 2026FDAOncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-…Z-2210-2026
December 31, 2025FDALifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2…Z-0965-2026
November 5, 2025FDAICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35Z-0357-2026
November 5, 2025FDAICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20Z-0354-2026
November 5, 2025FDAICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamb…Z-0332-2026
November 5, 2025FDAICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34Z-0356-2026
November 5, 2025FDAICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NSZ-0330-2026
November 5, 2025FDAICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955Z-0353-2026
November 5, 2025FDAICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5Z-0348-2026
November 5, 2025FDAICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201…Z-0365-2026

Questions about this company

How many recalls does ICU Medical, Inc. have?
Recalert has 242 U.S. recalls on record for ICU Medical, Inc., published between August 8, 2012 and September 23, 2026.
What was the most recent ICU Medical, Inc. recall?
FDA recall Z-3156-2026, published September 23, 2026: Plum administration sets
Which agencies have handled ICU Medical, Inc. recalls?
ICU Medical, Inc. appears as the recalling firm in recalls from: FDA (242).

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