This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

What to Do

Do not use affected product. Identify and destroy all affected devices, or quarantine affected product until disposal.

On October 2, 2025, ICU Medical, Inc. sent all affected customers a notice with the following actions:

• Check all inventory locations within your institution for affected products and discontinue use.
• Destroy all affected products following your institution’s process for destruction. If destruction is not immediately possible at your facility, then the product should be quarantined until disposal.
• Share this notification with all potential users of the device to ensure they are aware of the recall. If the devices are used at another location, please ensure this communication is delivered there.

Reason for Recall

ICU Medical is recalling IV Gravity Burette Set due to the burette component missing an internal shut-off valve intended to stop fluid flow. IV Gravity Burette Set products that are affected will be missing the blue shutoff valve within the burette chamber.

The use of affected product may cause serious adverse health consequences, including injuries caused by delay in therapy, over delivery/unrestricted flow, air being infused into the patient, and death.

As of September 25, ICU Medical has not reported any serious injuries or deaths associated with this issue.

Device Use

Administration sets and their accessories are single use, pre-sterilized, non-pyrogenic devices that provide access for the administration of fluids from a container to a patient's vascular system through the administration set’s needle or catheter, which is inserted into the vein.

Components used in the assembly of intravenous (IV) sets may be sold either as packaged finished goods or in bulk for inclusion in a set or tray of another manufacturer.

Contact Information

Customers in the U.S. with questions about this recall should contact ICU Medical Customer Service at 1-800-258-5361 or customerservice@icumed.com.

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.