CLASS II ONGOING Device recall · Reported 29 Nov 2023 · FDA Enforcement Report

Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal recalled

Convergent Dental is recalling Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal, distributed nationwide in the US. The recall was initiated on 1 Sep 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSolea Model 3.0: UDI-DI: 00850634007018; Serial Numbers: 0310516, 0310517, 0310518, 0310519, 0310520, 0310521, 0310522, 0310523, 0310524, 0310525, 0310526, 0310527, 0310528, 0310529, 0310530, 0310531, 0310532, 0310533, 0310534, 0310535, 0310536, 0310537, 0310538, 0310539, 0310540, 0310541, 0310542, 0310543, 0310317, 0310321, 0310322, 0300730; Solea Model 2.0: UDI-DI: 00850634007001; Serial Numbers: 0200822, 0200807, 0200810, 0200625, CDS2-U33W-1B-DE-15, 0200819, 0200401

Quantity recalled39 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0324-2024
FDA event ID: 93203
Recalling firm: Convergent Dental, Needham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 1 Sep 2023
FDA classified: 17 Nov 2023
Reported: 29 Nov 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

1 Sep 2023	Recall initiated by company
17 Nov 2023	Classified by FDA	+77 days
29 Nov 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

It has been found that potential unintended laser activation can occur without foot pedal depression.

Product as listed by the FDA

Solea Models 2.0 and 3.0 Laser Surgical Instrument, Foot Pedal assembly SUB-00434 with foot pedal CUS-00226 Rev. K reworked

Where it was distributed

Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.

Nationwide Alaska Alabama California Connecticut Florida Kentucky Maine Michigan Missouri Montana North Carolina Ohio Oregon Pennsylvania Tennessee Texas Utah Virginia Washington Wisconsin

Questions about this recall

Why was it recalled?

It has been found that potential unintended laser activation can occur without foot pedal depression.

Which lots are affected?

Solea Model 3.0: UDI-DI: 00850634007018; Serial Numbers: 0310516, 0310517, 0310518, 0310519, 0310520, 0310521, 0310522, 0310523, 0310524, 0310525, 0310526, 0310527, 0310528, 0310529, 0310530, 0310531, 0310532, 0310533, 0310534, 0310535, 0310536, 0310537, 0310538, 0310539, 0310540, 0310541, 0310542, 0310543, 0310317, 0310321, 0310322, 0300730; Solea Model 2.0: UDI-DI: 00850634007001; Serial Numbers: 0200822, 0200807, 0200810, 0200625, CDS2-U33W-1B-DE-15, 0200819, 0200401

Where was it sold?

Worldwide - US Nationwide distribution in the states of AK, AL, CA, CT, FL, KY, ME, MI, MO, MT, NC, OH, OR, PA, TN, TX, UT, VA, WA, WI and the country of Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Convergent Dental

All 2

Reported	Class	Recall	Company	Reason	Where
30 Oct 2013Device	CLASS II	Solea 1.0 Laser Surgical instrument for use in general recalled	Convergent Dental	Foreign Material	CT, MA, NY

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