TruDi NAV Suction — Class II medical device recall Z-2507-2024
Ongoing recall by Integra LifeSciences Corp., reported 2024-08-14, distributed in AL, AZ, CA, CO, CT, DE, FL, GA…. Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the
| Recall number | Z-2507-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2024-07-09 |
| Classified | 2024-08-05 |
| Reported by FDA | 2024-08-14 |
| Distributed | AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, PA, SC, SD, TN, TX, VA, VT, WI |
| Quantity | 265 units |
| UPC / GTIN / UDI-DI | 10705031245877 |
| Lot numbers | 2308140, 2308160, 2308180, 2309110, 2309150, 2310160 |
| Model numbers | TDNS000Z |
Product
TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
Reason for recall
Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on 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-2507-2024. 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.