Class III — Acclarent, Inc.
| Recalling firm | ACCLARENT, INC. |
|---|---|
| Registered facility | ACCLARENT, INC. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. |
| Product | RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. . |
| Quantity | 986 |
| Distribution | US in the state of Texas |
| Initiated | 2015-04-28 |
| Classified | 2015-06-09 |
| Terminated | 2015-06-10 |
| Recall number | Z-1740-2015 |
| 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 III recall — Acclarent, Inc. (Z-1740-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71232/
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