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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Sonendo Inc: Procedure Instruments with erroneous unit carton labels.

Agency Publication Date: November 14, 2022
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Affected Products

Product: GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R

Lot Numbers:
00858395006318
Number
Product: GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

GentleWave System Posterior CleanFlow Procedure Instrument (GW-PST-PI01) UDI-DI Code: 00195893912278 Lot Number: W2022080204R

Lot Numbers:
00195893912278
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91045
Status: Active
Manufacturer: Sonendo Inc
Manufactured In: United States
Units Affected: 2 products (15 instruments; 16 instruments)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.