GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Class I - DangerousWhat Should You Do?
- Check if you have this product: GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sonendo Inc
- Reason for Recall:
- Procedure Instruments with erroneous unit carton labels.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02
Product Codes/Lot Numbers:
GentleWave System Anterior/Premolar Procedure Instrument (GW-APM-PI02) UDI-DI Code: 00858395006318 Lot Number: W2022080941R
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0233-2023
Related Recalls
GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
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Procedure Instruments with erroneous unit carton labels.
GENTLEWAVE REF: FG-002-0001
Sonendo
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The console would continue to run for extended period when the foot pedal was released.