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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a calibration error causing incorrect display rather than a direct physical injury or contamination, fitting the moderate severity criteria for low-risk defects without reported harm.
Plain-English summary
Acclarent, Inc. is recalling 14 TruDi NAV Suction Instruments (TDNS000Z, 0 Degree Tip Angle) due to calibration issues. The defect causes the system to display incorrect tip orientation.
The recall affects three specific lots: 1901080, 1901177, and 1901219. These instruments have a shelf life of 30 reprocessing cycles. The products were distributed in the United States to Wisconsin, Illinois, Nebraska, California, Ohio, and New York.
No specific consumer action is detailed in the source text beyond the recall notification. Users should verify their lot numbers against the recalled list.
The recalled product
- Product
- TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
- Manufacturer
- Acclarent, Inc.
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 1901080
- 1901177
Distribution
Part of a larger recall action
This product is one of 3 recalled by Acclarent, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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