CLASS II ONGOING Device recall · Reported 14 Aug 2024 · FDA Enforcement Report

Soltive SuperPulsed Laser System Wireless Footswitch recalled

Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser System Wireless Footswitch, distributed nationwide in the US. The recall was initiated on 31 May 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: TFL-AFSWL; UDI-DI: 00821925044258; Serial Numbers: All Serial Numbers.

Quantity recalled1,838 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-2506-2024
FDA event ID: 94964
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 31 May 2024
FDA classified: 5 Aug 2024
Reported: 14 Aug 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

31 May 2024	Recall initiated by company
5 Aug 2024	Classified by FDA	+66 days
14 Aug 2024	Published in enforcement report	+9 days

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

Reason for recall

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

Product as listed by the FDA

Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.

Nationwide

Questions about this recall

Why was it recalled?

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

Which lots are affected?

Model: TFL-AFSWL; UDI-DI: 00821925044258; Serial Numbers: All Serial Numbers.

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.

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.

Other products in this recall event

2 other products · FDA event 94964

This product is part of a recall event; the main page for the event is Soltive Premium SuperPulsed Laser System recalled.

Reported	Class	Recall	Company	Reason	Where
14 Aug 2024	CLASS II	Soltive Premium SuperPulsed Laser System recalled	Olympus Corporation of the Americas	Other	Nationwide
14 Aug 2024	CLASS II	Soltive Pro SuperPulsed Laser System recalled	Olympus Corporation of the Americas	Other	Nationwide

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