Acclarent, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0825-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884

Product Classification:

Class II

Date Initiated: March 6, 2019

Date Posted: January 29, 2020

Recall Number: Z-0825-2020

Event ID: 84398

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.

Status: Terminated

Product Quantity:

Code Information:

Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.

Distribution Pattern:

US: WI, IL, NE, CA, OH, NY OUS: None

Voluntary or Mandated:

Voluntary: Firm initiated