Lower riskMedical device recall · FDA · Published March 6, 2019
Acclarent TruDi NAV Suction Recall: Calibration Issues Cause Incorrect Tip Display
Acclarent recalls TruDi NAV Suction instruments with calibration issues that show incorrect tip orientation. Affected lots have a 30-cycle reprocessing shelf life.
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Take action
Contact the company
📍Recalling firmAcclarent, Inc.33 Technology Dr · Irvine, CA 92618-2346
“Acclarent TruDi NAV Suction Recall: Calibration Issues Cause Incorrect Tip Display.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68907-acclarent-trudi-nav-suction-recall-calibration-issues-cause-incorrect-tip. Based on FDA recall #Z-0825-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0825-2020%22&limit=1).
The FDA announced on March 6, 2019, that Acclarent, Inc. voluntarily recalled TruDi NAV Suction instruments due to calibration issues causing incorrect tip orientation displays. The recall affects three specific lots of the devices distributed in several U.S. states.
How to tell if you have it
Brand: Acclarent
Product: TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01)
UPC: 10705031245884
Lot codes: 1901080, 1901177, 1901219
The hazard
The firm became aware that three lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system. The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.
Context
GovInfoNow's records show Acclarent, Inc. has two other recalls on record since November 12, 2021, including a September 21, 2023 recall for the TruDi Navigation System and a November 12, 2021 recall for TruDi NAV Suction Instruments. Other recent recalls of similar products include the March 2, 2026 Civco eTRAX Needle Sensor 12G Recall, the November 6, 2025 Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray Recall, and the March 2, 2026 Civco eTRAX Needle Sensor Recall.
How to tell if you have this one
Check for the model number TDNS070Z and lot numbers 1901080, 1901177, or 1901219. The instruments have a 30-cycle reprocessing shelf life.
Brand
Acclarent
Product
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US: WI, IL, NE, CA, OH, NY OUS: None
Recall number
Product, codes & lots
Quantity
Z-0824-2020
TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877; Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.
14 Suction Insstruments
Z-0825-2020
TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884; Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.
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Z-0826-2020
TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891; Lot # 1901080, 1901177, 1901219 The TruDi NAV Suction Instruments have a shelf life of 30 reprocessing cycles.
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Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot numbers 1901080, 1901177, or 1901219 on the instrument packaging.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “US: WI, IL, NE, CA, OH, NY OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Illinois, Nebraska, New York, Ohio, Wisconsin.
Recall timeline
FDA published this recall 11 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0825-2020 (March 6, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0825-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.