CLASS II ONGOING Device recall · Reported 18 Jun 2025 · FDA Enforcement Report
Powered Laser Surgical Instrument Soltive Pro SuperPulsed recalled
Olympus Corporation of the Americas is recalling Powered Laser Surgical Instrument Soltive Pro SuperPulsed Laser System, 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-1920-2025
- 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 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
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?
All lot/serial numbers for the following products: TFL-SLS UDI: 00821925044135; TFL-SLS-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 96723This product is part of a recall event; the main page for the event is Powered Laser Surgical Instrument Soltive SuperPulsed Laser recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Powered Laser Surgical Instrument Soltive SuperPulsed Laser recalled | Olympus Corporation of the Americas | Other | Nationwide | |
| 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 |
More recalls from Olympus Corporation of the Americas
All 423| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Olympus M3 Gold Autoclavable Lateral Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
| Device | CLASS II | Olympus Tripp-Lite P580-025 25ft DisplayPort Cable recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus M3 Gold Autoclavable Foroblique Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Fixed Pin Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
| Device | CLASS II | Olympus BiCOAG Hemostasis Probe Coaxial Connector recalled | Olympus Corporation of the Americas | Other | Nationwide |
Other Surgical Instruments recalls
All 3,891| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Adaptable Beach Chair Beach Chair surgical patient positioner recalled | Quantum OPS | Device Malfunction | Nationwide |
| Device | CLASS II | Laparoscopic Prostatectomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Halyard Laparoscopy Comprehensive Pack II recalled | GRI Medical & Electronic Technology | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Gyn Laparoscopy Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |