Class II — Cordis Corporation
| Recalling firm | Cordis US Corp. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Inability to deploy the stent or partial stent deployment. |
| Product | Cordis PRECISE (R) RX Nitinol Stent System (Biliary) |
| Quantity | 4,400 units in US; 3,100 units to Foreign Countries |
| Distribution | NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea. |
| Initiated | 2016-05-04 |
| Classified | 2016-06-10 |
| Terminated | 2019-07-26 |
| Recall number | Z-1947-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cordis Corporation (Z-1947-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74097/
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