TruDi Navigation System — Class II medical device recall Z-0127-2024
Ongoing recall by Acclarent, Inc., reported 2023-11-01, distributed in AL, AZ, CA, CO, CT, DC, FL, HI…. When using affected curette and software, there is a discrepancy between the actual curette tip location and t
| Recall number | Z-0127-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acclarent, Inc., Irvine, CA, United States |
| Recall initiated | 2023-09-21 |
| Classified | 2023-10-20 |
| Reported by FDA | 2023-11-01 |
| Distributed | AL, AZ, CA, CO, CT, DC, FL, HI, IA, ID, IL, KS, LA, MA, ME, MI, MN, MO, NC, NE, NY, OH, OK, OR, PA, SC, SD, TN, TX, WI |
| Quantity | 141 |
| Reason classes | packaging, software |
| UPC / GTIN / UDI-DI | 10846835018639 |
| Model numbers | ENS022B, FG-2000-00, TDC0005, TDC0005Z |
Product
TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
Reason for recall
When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.
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-0127-2024. 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.