FDA Device recall Z-0826-2020
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
- FDA Device
- Class II
- terminated
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891 by Acclarent, citing the firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0826-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-06 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Acclarent |
| Distribution | CA, IL, NE, NY, OH, WI |
Product
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
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.
Identifiers
| code_info | Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0826-2020%22
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