smiths medical ProPort Plastic Venous Access System — Class I medical device recall Z-1282-2025
Ongoing recall by Smiths Medical ASD, Inc., reported 2025-03-26. The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a
| Recall number | Z-1282-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Minneapolis, MN, United States |
| Recall initiated | 2025-02-13 |
| Classified | 2025-03-18 |
| Reported by FDA | 2025-03-26 |
| Quantity | 1,695 units |
| UPC / GTIN / UDI-DI | 10610586012686 |
| Lot numbers | 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, 6003890 |
| Model numbers | 21-4165-24 |
Product
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Reason for recall
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
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-1282-2025. 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.