TruDi NAV Suction Instruments: 0-Degree — Class II medical device recall Z-0415-2022
Ongoing recall by Acclarent, Inc., reported 2021-12-29, distributed in AL, AZ, CA, CO, CT, FL, GA, HI…. Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for vis
| Recall number | Z-0415-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acclarent, Inc., Irvine, CA, United States |
| Recall initiated | 2021-11-12 |
| Classified | 2021-12-22 |
| Reported by FDA | 2021-12-29 |
| Distributed | AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WI, WV, WY |
| Quantity | 1,543 |
| Reason classes | packaging |
| Lot numbers | 1903120, 1903137, 1903139, 1903250, 1903257, 1903259, 1904060, 1904067, 1904069, 1904180, 1904240, 1905017, 1905019, 1905030, 1905037, 1905070, 1905077, 1905139, 1906067, 1906079, 1906260, 1906267, 1907120, 1907127, 1907170, 1907220, 1907240, 1907260, 1908137, 1908157, 1908269, 1909279, 1909309, 1910299, 2003029, 2003040, 2003127, 2004029, 2009110, 2011240 and 9 more |
| Model numbers | TDNS000Z, TDNS070Z, TDNS090Z |
Product
TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
Reason for recall
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 for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0415-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.