ENT RES 100 ML Non-Sterile W CLAMP — Class II medical device recall Z-0017-2025
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-0017-2025 |
|---|---|
| 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 | 2,881,080 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 30610586044179 |
| Lot numbers | 4006930AB, 4006931AB, 4006932AB, 4006933AB, 4010548AB, 4010551AB, 4010559AB, 4010560AB, 4010561AB, 4010562AB, 4010563AB, 4010569AB, 4010570AB, 4010571AB, 4010572AB, 4010573AB, 4010574AB, 4016490AB, 4016491AB, 4016492AB, 4016493AB, 4016494AB, 4016495AB, 4016496AB, 4016497AB, 4022621AB, 4022622AB, 4022623AB, 4022624AB, 4022625AB, 4022626AB, 4022627AB, 4022628AB, 4022629AB, 4022630AB, 4022631AB, 4022632AB, 4022633AB, 4022634AB, 4022635AB and 163 more |
Product
ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
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-0017-2025. 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.