The Recall Desk

Manufacturer

Acclarent, Inc.

13 recalls in our database name Acclarent, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
13
Critical
0
Severe
0
Most recent
2023-11-01

Of the 13 recalls from Acclarent, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–13 of 13

  • HighFDA (Devices)·Z-0127-2024·2023-11-01

    TruDi Navigation System position discrepancy during ENT surgery

    A surgical navigation system used in ENT procedures may display incorrect curette tip positions, potentially causing delayed surgery, cerebrospinal fluid leaks, vision loss, or skull damage. The recall affects 141 units across 30 US states.

    Product
    TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
    Category
    Medical Device
    Distribution
    30 states
  • HighFDA (Devices)·Z-0415-2022·2021-12-29

    Surgical Suction Instruments Recalled for Calibration Defect Risk

    Acclarent's TruDi NAV Suction Instruments may be incorrectly calibrated, affecting surgical navigation accuracy. If undetected, the error could cause tissue damage, arterial injury, or nerve damage.

    Product
    TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Devices)·Z-0826-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling three lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0825-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling specific lots of TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0824-2020·2020-01-29

    Acclarent Recalls TruDi NAV Suction Instruments Due to Calibration Issues

    Acclarent, Inc. is recalling TruDi NAV Suction Instruments because calibration issues cause incorrect tip orientation displays.

    Product
    TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-1740-2015·2015-06-17

    Acclarent Recalls Expired RELIEVA FLEX Sinus Guide Catheter Units

    Acclarent, Inc. is recalling 986 RELIEVA FLEX Sinus Guide Catheter units distributed in Texas because one unit was found to be past its expiry date.

    Product
    RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1864-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 1,217 units distributed in the US, Belgium, Canada, and Saudi Arabia.

    Product
    Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1861-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and add warnings. The recall covers 2,366 units distributed in the US, Belgium, Canada, and Saudi Arabia.

    Product
    Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2013·2013-08-07

    Acclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1860-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1863-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1865-2013·2013-08-07

    Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1866-2013·2013-08-07

    Acclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections

    Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling and clarify instructional steps.

    Product
    Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Acclarent, Inc.

a subsidiary of Johnson and Johnson

Country
United States
Founded
2004

Official website

Source: Wikidata (Q4672650), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.