CADD Medication Cassette Reservoir — Class II medical device recall Z-0011-2025
Ongoing recall by Smiths Medical ASD Inc., reported 2024-10-30. Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and t
| Recall number | Z-0011-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2024-06-26 |
| Classified | 2024-10-18 |
| Reported by FDA | 2024-10-30 |
| Quantity | 385,558 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10610586027239 |
| Lot numbers | 3971709, 3983315, 3983316, 3983317, 3983318, 3983320, 3983321, 3983322, 3983323, 3983324, 3983325, 3983326, 3983327, 3983328, 3983329, 3983330, 3983331, 3983332, 3983334, 3983335, 4013353, 4013355, 4013356, 4013357, 4013358, 4013359, 4013360, 4013361, 4013362, 4013363, 4013373, 4013374, 4013375, 4013376, 4013377, 4013378, 4019427, 4019428, 4019429, 4019430 and 34 more |
Product
CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Reason for recall
Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0011-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.