Use caution Medical device recall · FDA · Published May 6, 2025

Olympus Soltive SuperPulsed Laser Fibers Recall: Risk of smoke, sparks, or fire during

Olympus recalls Soltive SuperPulsed Laser Fibers (models TFL-FBX150BS to TFL-FBX940S) due to potential smoke, sparks, or fire during surgical procedures. Affected units may fracture and cause thermal incidents.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1922-2025Medical device Olympus ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229

✎ GovInfoNow plain-language explainer

Olympus is recalling Soltive SuperPulsed Laser Fibers that could cause smoke, sparks, or fire during surgery due to fiber fracturing. This poses a risk of burns or fire to patients and staff if the fibers are used without proper safety measures. Read more at govinfonow.com/recall/52336-olympus-soltive-superpulsed-laser-fibers-recall-risk-of-smoke-sparks.

Source Summary by GovInfoNow · govinfonow.com/recall/52336-olympus-soltive-superpulsed-laser-fibers-recall-risk-of-smoke-sparks · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1922-2025

Cite this page

“Olympus Soltive SuperPulsed Laser Fibers Recall: Risk of smoke, sparks, or fire during.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52336-olympus-soltive-superpulsed-laser-fibers-recall-risk-of-smoke-sparks. Based on FDA recall #Z-1922-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1922-2025%22&limit=1).

The FDA announced on May 6, 2025, that Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser Fibers due to a potential for thermal incidents. The agency stated the hazard involves smoke, sparks, burning, or unsteady flames during clinical use.

How to tell if you have it

Brand: Olympus
Product: Soltive SuperPulsed Laser Fibers - Single Use
Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only), TFL-FBX940S-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150S-JA (Japan Only), TFL-FBX200S-JA (Japan Only), TFL-FBX365S-JA (Japan Only)
Lot Code: All lot numbers for the listed products
Units Affected: 551,154 units

The hazard

The FDA says the fracturing of the fiber causes or contributes to thermal incidents including smoke, sparks, burning, or unsteady flames during clinical use. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Recent brand recalls include a Tripp-Lite P580-025 DisplayPort Cable recall on 2026-08-27, an Olympus M3 Gold Autoclavable Lateral Telescope recall on 2026-08-24, and a BiCOAG Hemostasis Probe recall on 2026-08-19. Other recent recalls of similar products include a Lutronic CLARITY II Laser System recall on 2026-01-27, a Lutronic DermaV Laser System recall on 2026-08-06, and a FUJIFILM FDR Visionary Suite CH-200 X-ray Device recall on 2026-01-09.

How to tell if you have this one

Check for model numbers TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, or the Japan-only variants. These fibers are used in surgical procedures to deliver laser energy from the console to the treatment site.

Brand
Olympus
Category
Medical device

FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.

Recall number	Product, codes & lots	Quantity
Z-1920-2025	Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications. Component: No; All lot/serial numbers for the following products: TFL-SLS UDI: 00821925044135; TFL-SLS-JA (Japan Only)	201 units (100 US, 101 OUS)
Z-1921-2025	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; All lot/serial numbers for the following products: TFL-PLS UDI: 00821925044111; TFL-PLS-JA (Japan only);	1549 units (1025 US, 524 OUS)
Z-1922-2025	Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only), TFL-FBX940S-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150S-JA (Japan Only), TFL-FBX200S-JA (Japan Only), TFL-FBX365S-JA (Japan Only); Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.; Lot Code: All lot numbers for the following products: TFL-FBX150BS UDI: 00821925043923; TFL-FBX200BS UDI: 00821925043985; TFL-FBX150S UDI: 00821925043886; TFL-FBX200S UDI: 00821925043947; TFL-FBX365S UDI: 00821925044005; TFL-FBX550S UDI: 00821925044043; TFL-FBX940S UDI: 00821925044081; TFL-FBX150BS-JA (Japan Only); TFL-FBX550S-JA (Japan Only); TFL-FBX940S-JA (Japan Only); TFL-FBX200BS-JA (Japan Only); TFL-FBX150S-JA (Japan Only); TFL-FBX200S-JA (Japan Only); TFL-FBX365S-JA (Japan Only);	551,154 units (417859 US, 133710 OUS)
Z-1923-2025	Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-JA (Japan Only), TFL-FBX200R-JA (Japan Only), TFL-FBX550R-JA (Japan Only); Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.; Lot Code: All lot numbers for the following models: Model UDI: 5 Pack / 1 Piece: TFL-FBX150R UDI: 00821925043893 / 00821925043909 TFL-FBX200R UDI: 00821925043954 / 00821925043961 TFL-FBX365R UDI: 00821925044012 / 00821925044029 TFL-FBX550R UDI: 00821925044050 / 00821925044067 TFL-FBX940R UDI: 00821925044104 / 00821925044098 TFL-FBX940R-JA (Japan Only); TFL-FBX365R-JA (Japan Only); TFL-FBX200BS-JA (Japan Only); TFL-FBX150R-JA (Japan Only); TFL-FBX200R-JA (Japan Only); TFL-FBX550R-JA (Japan Only);	2,675 units (190 US, 2485 OUS)

Based on the official FDA remedy

What to do — step by step

Stop Using Immediately
Discontinue use of the recalled Soltive SuperPulsed Laser Fibers if they are in clinical use.
Contact Olympus
Reach out to Olympus Corporation of the Americas for guidance on safe disposal or replacement options.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 43 days after the firm started it.

May 6, 2025Firm started the recall
Jun 6, 2025FDA classified it Class II
Jun 18, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What models are affected?

The affected models are TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S, and Japan-only variants (TFL-FBX150BS-JA, TFL-FBX550S-JA, TFL-FBX940S-JA, TFL-FBX200BS-JA, TFL-FBX150S-JA, TFL-FBX200S-JA, TFL-FBX365S-JA).

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Link to this recall

<a href="https://govinfonow.com/recall/52336-olympus-soltive-superpulsed-laser-fibers-recall-risk-of-smoke-sparks">Olympus Soltive SuperPulsed Laser Fibers Recall: Risk of smoke, sparks, or fire during (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1922-2025 (May 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1922-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.