Reported May 7, 2025 · Ongoing
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers:…
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 NumbersTFL-SLS
- TFL-PLS 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
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 00821925044135UDI-DI: TFL-SLS - 00821925044135 2 0082192504411100821925044586TFL-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 3 00821925044593TFL-CSLU - 00821925044593 - Amount recalled
- 189
Where it was sold
Why it was recalled
Preset treatment parameters are not consistently being used in accordance with the IFU.
This product could cause temporary or reversible health problems — stop using it.
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