TruDi NAV Suction — Class II medical device recall Z-0825-2020
Terminated recall by Acclarent, Inc., reported 2020-01-29, distributed in CA, IL, NE, NY, OH, WI. The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing in
| Recall number | Z-0825-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acclarent, Inc., Irvine, CA, United States |
| Recall initiated | 2019-03-06 |
| Classified | 2020-01-18 |
| Reported by FDA | 2020-01-29 |
| Distributed | CA, IL, NE, NY, OH, WI |
| UPC / GTIN / UDI-DI | 10705031245884 |
| Lot numbers | 1901080, 1901177, 1901219 |
Product
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Reason for recall
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0825-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.