ICU Medical recalls

ICU Medical's 0.9% Sodium Chloride Injection (100 mL) may be mislabeled. Some bags marked as sodium chloride may actually contain potassium chloride instead. This mix-up affects lot 1042188, expiring 10/31/2027, distributed nationwide.

Serious·FDA·Sep 30, 2026

ICU Medical's CADD Yellow Medication Cassette Reservoirs may leak medication at the connection point between the luer connector and tubing. This leakage could delay or stop medication delivery, reduce the amount of medication received, expose patients to contamination, or allow air to enter the bloodstream.

Serious·FDA·Sep 23, 2026

ICU Medical is recalling eight IV administration sets with drip chambers. The drip chambers may have black specks, which may come from discolored plastic left behind during manufacturing. The company has not ruled out discoloration or particles in the fluid path. No injuries have been reported.

Moderate·FDA·Sep 23, 20268 products

One lot of ICU Medical 0.9% Sodium Chloride Injection (a salt solution) was found to contain 10 mEq Potassium Chloride Injection instead. The vial had the correct outer label but the wrong product inside. This was discovered through a customer complaint.

Serious·FDA·Sep 17, 2026

ICU Medical's Hotline Fluid Warming Set (model L-70), a single-use device used to warm blood and IV fluids before delivery to patients, may leak due to inadequate solvent application at the tubing-to-connector bond in certain production lots. This defect could affect proper fluid delivery during patient care.

Moderate·FDA·Jul 29, 2026

ICU Medical is recalling two infusion pump products, the Plum Duo and Plum Solo Precision IV Pump, because in a specific scenario the pump may not count down the Volume to be Infused on its Delivery screen and could deliver up to twice the programmed volume at the set rate. The recall covers about 17,584 units distributed across the US and Canada, and no injuries have been reported.

Serious·FDA·Jul 22, 20262 products

ICU Medical is recalling three Plum infusion pump models, covering 13,613 units each. Under certain conditions, the pump may not show a soft limit alert or warn the clinician of a soft limit violation before delivery starts, which could lead to under- or over-delivery of medication. No injuries have been reported.

Moderate·FDA·Jun 17, 20263 products

ICU Medical oncology infusion kits with extension sets may develop leaks during chemotherapy administration. If a leak occurs during therapy, patients may receive less medication than intended, and healthcare workers or patients could be exposed to hazardous drugs.

Moderate·FDA·May 27, 2026

ICU Medical is recalling three Plum infusion pump models: the Plum Duo Infusion Pump, Plum Duo Precision IV Pump, and Plum Solo Precision IV Pump. In certain cases, the pump's automatic flush feature for piggyback therapy can show a limit violation message that prevents the flush from being programmed. No injuries have been reported.

Moderate·FDA·Jan 28, 20263 products

ICU Medical's Tego Connector needle-free access devices have a silicone seal that may bulge, separate, or tear. This defect can cause fluid leaks, blockages, inability to draw or inject medication, and potential exposure to contamination or air in the bloodstream during hemodialysis or IV therapy.

Serious·FDA·Jan 28, 2026

ICU Medical is recalling two products, the Pulsator Arterial Blood Sampling Kit and the Portex Spinal Tray, with 64,290 affected units each. Some syringes may have a crack on the syringe collar, which can cause delayed or repeated blood draws or fluid delivery, and blood leakage during arterial sampling or fluid delivery. No injuries have been reported.

Moderate·FDA·Jan 21, 20262 products

ICU Medical identified a batch of defective speakers in some Plum Duo Infusion Pumps that may fail silently. If the speaker fails, the pump will not produce audible alarms, alerts, or sound feedback when you touch the screen. This could delay recognition of important pump notifications.

Serious·FDA·Jan 21, 2026

ICU Medical's LifeShield Infusion Safety Software v2.2 has a software issue that limits concentration settings to one decimal place instead of three. This may force users to set drug limits differently than the manufacturer recommends, potentially causing patients to receive too much or too little medication.

Moderate·FDA·Dec 31, 2025

ICU Medical's LifeShield Drug Library Management software version 2.2.1 has a problem where the Change Summary review tool stops working correctly after a library migration. This affects only customers who upgraded from version 2.1x and use Plum Duo v1.1 infusion pumps. When the review tool doesn't work, staff may not catch errors in pump settings.

Moderate·FDA·Dec 31, 2025

Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq

FDA·Nov 26, 20252 products