CLASS II ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report

Smiths Medical CADD Medication Cassette Reservoir recalled

ICU Medical is recalling Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. The recall was initiated on 6 Aug 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 10610586022128, Lot Numbers: 6022010, 6026827, 6026828, 6026829, 6026830, 6026831, 6037750, 6037751, 6037752, 6037753, 6053980, 6053981, 6053982, 6053983, 6062689, 6062688, 6063845, 6062691

Quantity recalled265500 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2523-2025
FDA event ID: 97317
Recalling firm: ICU Medical, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 6 Aug 2025
FDA classified: 4 Sep 2025
Reported: 10 Sep 2025
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Foreign Material
Device type: Masks, Gloves & PPE

Timeline

6 Aug 2025	Recall initiated by company
4 Sep 2025	Classified by FDA	+29 days
10 Sep 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI 10610586022128, Lot Numbers: 6022010, 6026827, 6026828, 6026829, 6026830, 6026831, 6037750, 6037751, 6037752, 6037753, 6053980, 6053981, 6053982, 6053983, 6062689, 6062688, 6063845, 6062691

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 97317

This product is part of a recall event; the main page for the event is Smiths Medical CADD Medication Cassette Reservoir recalled.

Reported	Class	Recall	Company	Reason	Where
10 Sep 2025	CLASS II	Smiths Medical CADD Medication Cassette Reservoir recalled	ICU Medical	Foreign Material	MN
10 Sep 2025	CLASS II	Smiths Medical CADD Medication Cassette Reservoir recalled	ICU Medical	Foreign Material	MN
10 Sep 2025	CLASS II	Smiths Medical NRFit CADD Yellow Medication Cassette recalled	ICU Medical	Foreign Material	MN
10 Sep 2025	CLASS II	Smiths Medical CADD" Medication Cassette Reservoir recalled	ICU Medical	Foreign Material	MN
10 Sep 2025	CLASS II	Smiths Medical CADD" Yellow Medication Cassette Reservoir recalled	ICU Medical	Foreign Material	MN

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