Class II — Acclarent, Inc.
| Recalling firm | ACCLARENT, INC. |
|---|---|
| Registered facility | ACCLARENT, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. |
| Product | TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 |
| Distribution | US: WI, IL, NE, CA, OH, NY OUS: None |
| Initiated | 2019-03-06 |
| Classified | 2020-01-18 |
| Recall number | Z-0826-2020 |
| 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 — Acclarent, Inc. (Z-0826-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84398/
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