Class II — Stryker, Inc.
| Recalling firm | STRYKER CORP. |
|---|---|
| Registered facility | View this company's 61 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The microcatheter IFU contains an intended use that has not been evaluated by the FDA. |
| Product | Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm |
| Quantity | 63 units |
| Distribution | US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA. |
| Initiated | 2023-12-06 |
| Classified | 2024-02-14 |
| Recall number | Z-1085-2024 |
| 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 — Stryker, Inc. (Z-1085-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93678/
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