GentleWave System Posterior Procedure Instrument Recall for Erroneous Carton Labels
Sonendo Inc is recalling 16 GentleWave System Posterior CleanFlow procedure instruments with lot number W2022080204R due to erroneous unit carton labels that could affect proper identification and use.
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: FDA Class II designation with a labeling error on packaging that could affect proper instrument identification and use. No injuries or illnesses have been reported.
Plain-English summary
Sonendo Inc is recalling the GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) model REF GW-PST-PI01. The recall involves 16 units with lot number W2022080204R that feature erroneous labeling on the unit cartons.
The procedure instruments have incorrect unit carton labels, which could affect proper identification and selection of the instruments during clinical use.
The affected instruments were distributed worldwide, with U.S. distribution specifically in the state of Ohio and to Canada.
The recalled product
- Product
- GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01
- Manufacturer
- Sonendo Inc
- Hazard
- Affected units
- 16
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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