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 flow stop, 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 10610586027239, Lot Numbers: 4468669, 4468670, 4468671, 4468677, 6004936, 6005591, 6005593, 6005601, 6012443, 6012470, 6012472, 6012474, 6012477, 6022033, 6022034, 6022039, 6022040, 6022041, 6022045, 6022046, 6022047, 6022048, 6022049, 6022051, 6022053, 6026851, 6026853, 6026854, 6026855, 6026856, 6026857, 6026858, 6026859, 6026861, 6026862, 6026863, 6026864, 6026865, 6026866, 6026867, 6026868, 6026869, 6026870, 6026872, 6026873, 6026874, 6026875, 6037772, 6037773, 6037774, 6037775, 6037776, 6037777, 6037778, 6037779, 6037780, 6037781, 6037782, 6053814, 6054005, 6054007, 6054008, 6054009, 6054010, 6054011, 6054013, 6054014, 6056238, 6062718, 6054012, 6062712, 6062710, 6062699, 6062714, 6062700, 6062701, 6062702, 6062705, 6062716, 6062703, 6062706, 6062721, 6062711, 6062723, 6062717

Quantity recalled987911 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-2526-2025
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 flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24

Where it was distributed

Worldwide distribution.

Questions about this recall

Is Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer recalled?

Yes. ICU Medical recalled Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer on 6 Aug 2025. The recall is Class II and its status is Ongoing. Recall number Z-2526-2025.

Why was it recalled?

Which lots are affected?

UDI/DI 10610586027239, Lot Numbers: 4468669, 4468670, 4468671, 4468677, 6004936, 6005591, 6005593, 6005601, 6012443, 6012470, 6012472, 6012474, 6012477, 6022033, 6022034, 6022039, 6022040, 6022041, 6022045, 6022046, 6022047, 6022048, 6022049, 6022051, 6022053, 6026851, 6026853, 6026854, 6026855, 6026856, 6026857, 6026858, 6026859, 6026861, 6026862, 6026863, 6026864, 6026865, 6026866, 6026867, 6026868, 6026869, 6026870, 6026872, 6026873, 6026874, 6026875, 6037772, 6037773, 6037774, 6037775, 6037776, 6037777, 6037778, 6037779, 6037780, 6037781, 6037782, 6053814, 6054005, 6054007, 6054008, 6054009, 6054010, 6054011, 6054013, 6054014, 6056238, 6062718, 6054012, 6062712, 6062710, 6062699, 6062714, 6062700, 6062701, 6062702, 6062705, 6062716, 6062703, 6062706, 6062721, 6062711, 6062723, 6062717

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

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