FDAClass IISeptember 10, 2025

Smiths Medical CADD" Yellow Medication Cassette recall

Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code…

Why was Smiths Medical CADD" Yellow Medication Cassette 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 10610586027192, Lot Numbers: 6012453, 6022016, 6022019, 6026832, 6026833, 6026834, 6026835, 6026836, 6037755, 6037756, 6037757, 6037758, 6037759, 6037760, 6053986, 6053987, 6053988, 6053990, 6053989, 6053985, 6062696, 6062694, 6062695

Product
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code…
Recalling firm
ICU Medical Inc.
Quantity
289098 units
Distribution
Worldwide distribution.
Recall date
September 10, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls