Brand Name: Powered Laser Surgical Instrument Product recall
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product…
Why was Brand Name: Powered Laser Surgical Instrument Product recalled?
Preset treatment parameters are not consistently being used in accordance with the IFU.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SOLTIVE Pro SuperPulsed Laser System: UDI-DI: TFL-SLS - 00821925044135; TFL-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; TFL-CSLU - 00821925044593
- Product
- Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 189
- Distribution
- Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.
- Recall date
- May 7, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)