smiths medical portex — Class II medical device recall Z-0145-2025
Ongoing recall by Smiths Medical ASD Inc., reported 2024-10-30. Uncertainty in the seal integrity of the sterile packaging.
| Recall number | Z-0145-2025 |
|---|---|
| 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 | 2024-07-18 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Quantity | 9,133 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 35019315011003, 35019315022405 |
| Lot numbers | 4122012, 4131841, 4133227 |
| Model numbers | 100/276/000 |
Product
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Reason for recall
Uncertainty in the seal integrity of the sterile packaging.
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-0145-2025. 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.