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
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
Why was it 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.
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 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 97317This product is part of a recall event; the main page for the event is Smiths Medical CADD Medication Cassette Reservoir recalled.
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