Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Smiths Medical CADD" Medication Cassette Reservoir with flow stop Recalled by ICU Medical Inc. Due to Certain CADD 50 mL and 100 mL Medication...

Date: August 6, 2025
Company: ICU Medical Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical Inc. directly.

Affected Products

Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24

Quantity: 211750 units

Why Was This Recalled?

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Where Was This Sold?

Worldwide distribution.

About ICU Medical Inc.

ICU Medical Inc. has 8 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report