ENT RES — Class II medical device recall Z-0018-2025
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-0018-2025 |
|---|---|
| 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 | 120,960 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 30610586044186 |
| Lot numbers | 3997242-ENG, 4040000AB, 4040001AB, 4040002AB, 4040007AB, 4040008AB, 4040009AB, 4146021AB |
Product
ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
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-0018-2025. 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.