CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report

Powered Laser Surgical Instrument Soltive Premium recalled

Olympus Corporation of the Americas is recalling Powered Laser Surgical Instrument Soltive Premium SuperPulsed Laser System, distributed nationwide in the US. The recall was initiated on 6 May 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lot/serial numbers for the following products: TFL-PLS UDI: 00821925044111; TFL-PLS-JA (Japan only);

Quantity recalled1549 units (1025 US, 524 OUS)

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-1921-2025
FDA event ID: 96723
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 6 May 2025
FDA classified: 6 Jun 2025
Reported: 18 Jun 2025
Type: Voluntary: Firm initiated
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

6 May 2025	Recall initiated by company
6 Jun 2025	Classified by FDA	+31 days
18 Jun 2025	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

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: N/A

Where it was distributed

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

Nationwide California Delaware

Questions about this recall

Why was it recalled?

Which lots are affected?

All lot/serial numbers for the following products: TFL-PLS UDI: 00821925044111; TFL-PLS-JA (Japan only);

Where was it sold?

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

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

3 other products · FDA event 96723

This product is part of a recall event; the main page for the event is Powered Laser Surgical Instrument Soltive SuperPulsed Laser recalled.

Reported	Class	Recall	Company	Reason	Where
18 Jun 2025	CLASS II	Powered Laser Surgical Instrument Soltive SuperPulsed Laser recalled	Olympus Corporation of the Americas	Other	Nationwide
18 Jun 2025	CLASS II	Powered Laser Surgical Instrument Soltive Reusable Laser Fibers recalled	Olympus Corporation of the Americas	Other	Nationwide
18 Jun 2025	CLASS II	Powered Laser Surgical Instrument Soltive Pro SuperPulsed recalled	Olympus Corporation of the Americas	Other	Nationwide

More recalls from Olympus Corporation of the Americas

All 415

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Sterility	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide