CADD Medication Cassette Reservoir — Class II medical device recall Z-0013-2025
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-0013-2025 |
|---|---|
| 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 | 119,535 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10610586027215 |
| Lot numbers | 3983337, 3983338, 3983339, 3983340, 3988532-ENG, 4013366, 4013367, 4034019, 4034021, 4034022, 4037748, 4037749, 4040247, 4040248, 4042839, 4042840, 4042841, 4042842, 4048891, 4052405, 4052406, 4052407, 4052408, 4052409 |
Product
CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
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-0013-2025. 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.