Terumo Surflo Winged Infusion Set with Filter and Needle Protection — Class II medical device recall Z-0551-2016
Terminated recall by Terumo Medical Corp, reported 2015-12-30, distributed in CA. Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filte
| Recall number | Z-0551-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Medical Corp, Somerset, NJ, United States |
| Recall initiated | 2015-11-23 |
| Classified | 2015-12-24 |
| Reported by FDA | 2015-12-30 |
| Terminated | 2017-08-01 |
| Distributed | CA |
| Quantity | 80,500 units |
| Lot numbers | 1508023, 1509011, 1510004 |
Product
Terumo Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Product Code: SV-S25FL35.
Reason for recall
Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).
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-0551-2016. 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.