--- title: "Acclarent, Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Acclarent, Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/acclarent-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Acclarent, Inc. recall records **2** reported ongoing 2 records in this archive. Latest source date Sep 21, 2023. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Sep 21, 2023 FDA device enforcement ### [TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005](https://isitonrecall.com/recall/fda-device-z-0127-2024-trudi-navigation-system-model-fg-2000-00-catalog-ens022b-when-used-with-trudi-curette-models-tdc0005/) 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... Class II Reported ongoing Distribution: US: CA, IL, WI, MA, TX, CO, FL, ID, KS, OH, OR, NE, MO, AZ, HI, TN, NY, ME, SC, NC, CT, DC, MN, LA, OK, PA, AL, IA, MI, SD [Official source for TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Model...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0127-2024%22) Nov 12, 2021 FDA device enforcement ### [TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z](https://isitonrecall.com/recall/fda-device-z-0415-2022-trudi-nav-suction-instruments-0-degree-ref-tdns000z-70-degree-ref-tdns070z-and-90-degree-ref-tdns090/) 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 intraprocedura... Class II Reported ongoing Distribution: US: AZ, MI, IA, LA, IL, VA, SC, NY, IN, OR, SD, TX, PA, NE, FL, CT, MN, NV, CA, NJ, UT, AL, MA, WI, TN, WV, OH, NC, KY, HI¿, OK, GA, CO, MO, WY, MS, NH, HI, MD, ID [Official source for TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0415-2022%22) ## Reasons in these listed records - 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 de... - 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... These examples come from this result page and are not a ranking of every recall reason. ## Checking Acclarent, Inc. ### Is there a recall on acclarent, inc. right now? This archive contains 2 records, including 2 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Acclarent, Inc.](https://isitonrecall.com/check/?q=Acclarent%2C%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)