ICU Medical, Inc. recalls CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-…

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.

On August 20, 2026, the firm began notifying affected customers via Urgent Medical Device Correction letters. Customers were informed that certain reservoirs may exhibit fluid leakage at the joint between the connector and the tubing. Customers were instructed to check all inventory locations for affected product and discontinue use. All affected products should be destroyed following their institution's destruction process. If destruction is not immediately possible at your facility, quarantine the products until disposal. Customers should share the notification with all potential users of the reservoirs, and notify any accounts to whom the affected products have been further distributed. The firm will provide replacement products to affected customers upon receipt of a completed Customer Response Form to certify product destruction.

• FDA enforcement recordOfficial FDA database entry for Z-3212-2026
• FDA 510(k) clearance · K162219The device's official FDA premarket clearance record
• FDA device classification · LHIOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ICU Medical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.