CLASS II ONGOING Device recall · Reported 7 May 2025 · FDA Enforcement Report

Powered Laser Surgical Instrument Soltive Pro SuperPulsed recalled

Olympus Corporation of the Americas is recalling Powered Laser Surgical Instrument Soltive Pro SuperPulsed Laser System, distributed nationwide in the US. The recall was initiated on 4 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSOLTIVE Pro SuperPulsed Laser System: UDI-DI: TFL-SLS - 00821925044135; TFL-PLS - 00821925044111 All units included Powered Laser Surgical Instrument - Laser module component information Name: TFL Premium Laser Unit, TFL Standard Laser Unit UDI-DI: TFL-CPLU - 00821925044586; TFL-CSLU - 00821925044593

Quantity recalled189

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-1715-2025
FDA event ID: 96566
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 4 Apr 2025
FDA classified: 1 May 2025
Reported: 7 May 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

4 Apr 2025	Recall initiated by company
1 May 2025	Classified by FDA	+27 days
7 May 2025	Published in enforcement report	+6 days

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

Reason for recall

Preset treatment parameters are not consistently being used in accordance with the IFU.

Product as listed by the FDA

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No

Where it was distributed

Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.

Nationwide California Delaware

Questions about this recall

Why was it recalled?

Preset treatment parameters are not consistently being used in accordance with the IFU.

Which lots are affected?

SOLTIVE Pro SuperPulsed Laser System: UDI-DI: TFL-SLS - 00821925044135; TFL-PLS - 00821925044111 All units included Powered Laser Surgical Instrument - Laser module component information Name: TFL Premium Laser Unit, TFL Standard Laser Unit UDI-DI: TFL-CPLU - 00821925044586; TFL-CSLU - 00821925044593

Where was it sold?

Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.

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.

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