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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91045

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 14, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Sonendo Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0233-2023
Recall number
Z-0233-2023
Initiated
October 14, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Sonendo Inc
Quantity
15 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Procedure Instruments with erroneous unit carton labels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Procedure Instruments with erroneous unit carton labels.

Code information

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

Distribution pattern

Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.

device · product 2 of 2

GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

Z-0234-2023
Recall number
Z-0234-2023
Initiated
October 14, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Sonendo Inc
Quantity
16 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Procedure Instruments with erroneous unit carton labels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Procedure Instruments with erroneous unit carton labels.

Code information

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

Distribution pattern

Worldwide - U.S. Nationwide distribution in the state of OH and the country of Canada.