Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

TruDi NAV Suction Recalled by Acclarent, Inc. Due to The firm became aware that three (3) lots...

Date: March 6, 2019
Company: Acclarent, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Acclarent, Inc. directly.

Affected Products

TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891

Why Was This Recalled?

The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.

Where Was This Sold?

This product was distributed to 6 states: CA, IL, NE, NY, OH, WI

Affected (6 states)Not affected

About Acclarent, Inc.

Acclarent, Inc. has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report