20IN — Class II medical device recall Z-0745-2024
Ongoing recall by Smiths Medical Asd Inc, reported 2024-01-24, distributed nationwide. There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of
| Recall number | Z-0745-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical Asd Inc, Dublin, OH, United States |
| Recall initiated | 2023-11-10 |
| Classified | 2024-01-17 |
| Reported by FDA | 2024-01-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA |
| Quantity | 31,685 total |
| Reason classes | packaging |
| Lot numbers | 4398428, 4404690 |
Product
20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR
Reason for recall
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
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-0745-2024. 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.