Angio-Seal Evolution Vascular Closure Device — Class II medical device recall Z-2337-2018
Terminated recall by Terumo Medical Corp, reported 2018-07-11, distributed in AL, CA, FL, IA, IN, MI, MO, NC…. Two lots of product were released for distribution prior to the completion of all required validation and lot
| Recall number | Z-2337-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Medical Corp, Somerset, NJ, United States |
| Recall initiated | 2018-04-09 |
| Classified | 2018-06-29 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2019-04-19 |
| Distributed | AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, TX |
| Quantity | 240 |
| Reason classes | sterility |
| Model numbers | C610135 |
Product
Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Reason for recall
Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
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-2337-2018. 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.