GentleWave System APM Procedure Instruments recalled for erroneous carton labels
Sonendo Inc is recalling 15 GentleWave System APM Procedure Instruments (Model GW-APM-PI02) due to erroneous unit carton labels. The instruments were distributed worldwide, including Ohio and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is a Class II FDA recall involving labeling errors on medical device cartons with no reported illnesses or injuries. The hazard is documentation-related rather than indicating direct patient harm, which corresponds to the 'Minor labeling errors' category in the severity rubric.
Plain-English summary
Sonendo Inc is recalling the GentleWave System APM Procedure Instrument with Matrix (Model GW-APM-PI02) due to erroneous unit carton labels. The recall affects 15 instruments bearing UDI-DI Code 00858395006318 and Lot Number W2022080941R.
These endodontic procedure instruments were distributed worldwide, including the United States (Ohio) and Canada. The specific details of the carton label errors are not provided in the available regulatory information.
The FDA classified this as a Class II recall. No illnesses or injuries have been reported in connection with this labeling issue.
The recalled product
- Product
- GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
- Manufacturer
- Sonendo Inc
- Hazard
- Affected units
- 15
Distribution
Part of a larger recall action
This product is one of 2 recalled by Sonendo 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.
See all 2 products in this recall →Related recalls
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