RegWardenFDA facility compliance records
Company

ACCLARENT, INC.

5 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2015: 1 recalls; 2019: 1 recalls; 2021: 1 recalls; 2023: 1 recalls1’13’141’15’16’17’181’19’201’21’221’23’24’25’26
  • Recalls (5)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-09-21
    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 delay…
  • Class IIOngoing2021-11-12
    Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential fo…
  • Class IITerminated2019-03-06
    The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
  • Class IIITerminated2015-04-28
    Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
  • Class IITerminated2013-01-11
    Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “ACCLARENT, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9068915-acclarent-inc/

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