Sonendo GentleWave Foot Pedal Recall Due to Extended Console Operation
Sonendo Inc is recalling 460 GentleWave foot pedals because the console may continue running for an extended period after the pedal is released.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (unintended device operation) where no specific injuries have been reported in the source text.
Plain-English summary
Sonendo Inc is recalling 460 foot pedals (P/N: 102-0186-001) associated with the GENTLEWAVE REF: FG-002-0001 device. The recall affects specific lot numbers including RI18.00462, RI18.00719, RI18.01283, RI18.01608, RI18.02168, RI18.02608, RI18.02882, RI18.02898, RI18.02899, RI18.03196, RI18.03264, RI18.03700, RI19.00901, and RI19.01330.
The recall was initiated because the console would continue to run for an extended period when the foot pedal was released. This malfunction could result in unintended device operation.
The affected units were distributed to dental practices and other healthcare facilities in 48 U.S. states and the District of Columbia. No foreign consignees were involved. Users should stop using the affected foot pedals and contact Sonendo Inc for instructions on replacement or repair.
The recalled product
- Product
- GENTLEWAVE REF: FG-002-0001
- Manufacturer
- Sonendo Inc
- Hazard
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 (15)
- Foot Pedal
- P/N: 102-0186-001 of GENTLEWAVE REF: FG-002-0001 device: Lot#: RI18.00462
- RI18.00719
- RI18.01283
- RI18.01608
- RI18.02168
- RI18.02608
- RI18.02882
- RI18.02898
- RI18.02899
- RI18.03196
- RI18.03264
- RI18.03700
- RI19.00901
- RI19.01330
Distribution
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