Reported Jun 18, 2025 · Ongoing
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number:…
Olympus Corporation of the Americas
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229
Is this the product you have?
- Brand NamePowered
- Laser Surgical Instrument Product NameSOLTIVE Pro SuperPulsed
- Laser System Model/Catalog NumberTFL-SLS, TFL-SLS-JA (Japan only)
- Product DescriptionSOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications
- ComponentNo
- Lot codes and dates
- All lot/serial
- numbers for the following productsTFL-SLS
- UDI00821925044135; TFL-SLS-JA (Japan Only)
- Amount recalled
- 201 units (100 US, 101 OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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