Acclarent, Inc. recalls
Every recall we track for Acclarent, Inc. — 5 in all, from 2019–2023 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Acclarent, Inc. peaked in 2019 (3); 5 since 2017.
All FDA recall records for Acclarent, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 3 | 0 | 3 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 0 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Acclarent, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Acclarent, Inc. recalls
3 shown- Use cautionMedical device
Acclarent, Inc. recalls TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Acclarent recalls TruDi Navigation System (FG-2000-00) used with specific curettes due to location mismatch during ENT surgery, risking prolonged procedures, CSF leaks, or structural damage. Affected units sold with certain software versions.
AcclarentSep 21, 2023 - Use cautionMedical device
Acclarent, Inc. recalls TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Acclarent recalls TruDi NAV Suction Instruments (0°, 70°, 90° models) due to calibration errors that may cause tissue damage or carotid artery injury during surgery. Affected units include specific lot numbers from 2019-2021.
AcclarentNov 12, 2021 - Lower riskMedical device
Acclarent, Inc. recalls TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Acclarent recalls TruDi NAV Suction instruments with calibration issues that show incorrect tip orientation. Affected lots have a 30-cycle reprocessing shelf life.
AcclarentMar 6, 2019
Acclarent, Inc. recall questions
How many recalls has Acclarent, Inc. had?
5 recalls from Acclarent, Inc. are on record with U.S. safety agencies, from 2019–2023.
What is the most recent Acclarent, Inc. recall?
Acclarent, Inc. recalls TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005, dated Sep 21, 2023. Every Acclarent, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Acclarent, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Acclarent, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.