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.
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 3/5 (High).
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
Related recalls
Same manufacturer · Sonendo Inc
See all →- ModerateGentleWave System APM Procedure Instruments recalled for erroneous carton labels
FDA (Devices) · 2022-11-23
- ModerateGentleWave System Posterior Procedure Instrument Recall for Erroneous Carton Labels
FDA (Devices) · 2022-11-23
Same hazard · unintended operation
See all →- SevereWinnebago Ekko Motorhomes Recalled Over Generator Software Fault
NHTSA · 2026-07-30
- HighRosenbauer Fire Trucks Recalled for Winch Remote Water Ingress Risk
NHTSA · 2023-07-31
- HighPushTracker E3 software failure may prevent stopping SmartDrive motor
FDA (Devices) · 2023-07-05
- HighFelling Trailers Recall Warn Winch Remotes Due to Water Intrusion Risk
NHTSA · 2023-03-31
- High
Similar recalls
- ModerateGentleWave System Posterior Procedure Instrument Recall for Erroneous Carton Labels
FDA (Devices) · 2022-11-23
- HighSolea Laser Surgical Instrument Models 2.0 and 3.0 Recall for Unintended Activation
FDA (Devices) · 2023-11-29
- ModerateGentleWave System APM Procedure Instruments recalled for erroneous carton labels
FDA (Devices) · 2022-11-23
- SevereBien-Air Surgery Foot Pedal Recalled Due to Magnet Detachment Risk
FDA (Devices) · 2020-10-28
- SevereEntellus Medical Shaver System Foot Pedal Recalled for Magnet Defect
FDA (Devices) · 2020-10-28
- HighZenition 50 Medical Imaging Devices Wireless Foot Switch Recall
FDA (Devices) · 2025-04-30