CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Powered Laser Surgical Instrument Soltive SuperPulsed Laser recalled
Olympus Corporation of the Americas is recalling Powered Laser Surgical Instrument Soltive SuperPulsed Laser Fibers - Single Use, 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
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-1922-2025
- 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
- Other Reasons
- 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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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);
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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Powered Laser Surgical Instrument Soltive Premium recalled | Olympus Corporation of the Americas | Device Malfunction | Nationwide | |
| CLASS II | Powered Laser Surgical Instrument Soltive Reusable Laser Fibers recalled | Olympus Corporation of the Americas | Other | Nationwide | |
| CLASS II | Powered Laser Surgical Instrument Soltive Pro SuperPulsed recalled | Olympus Corporation of the Americas | Other | Nationwide |
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|---|---|---|---|---|---|
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