Use cautionMedical device recall · FDA · Published June 30, 2021
Olympus Soltive Laser Systems Recall: Risk of Thermal Injury from Ureteral Stone Treatment
Olympus recalls Soltive Premium and Pro Super Pulsed Laser Systems due to risk of thermal injury when treating ureteral stones with settings exceeding 20W. Affected units have Software Version 2.0 and specific serial numbers.
“Olympus Soltive Laser Systems Recall: Risk of Thermal Injury from Ureteral Stone Treatment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62267-olympus-soltive-laser-systems-recall-risk-of-thermal-injury-from. Based on FDA recall #Z-2294-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2294-2021%22&limit=1).
The FDA announced on June 30, 2021, that Olympus Corporation of the Americas is recalling Soltive Premium Super Pulsed Laser System (TFL-PLS) and Pro Super Pulsed Laser System (TFL-SLS) devices. The hazard involves thermal injury to patients when users exceed the 20W standard presets during ureteral stone treatment.
How to tell if you have it
Brand: Olympus
Products: Soltive Premium Super Pulsed Laser System (TFL-PLS), Pro Super Pulsed Laser System (TFL-SLS)
Software Version: 2.0
Serial numbers: all serial numbers
Quantity: 408 units
The hazard
The recall cites thermal injury following dusting and fragmenting treatment of ureteral stones when the user exceeded the 20W standard presets. The devices are intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue in urology, lithotripsy, gastroenterological surgery, and gynecological surgery.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since August 18, 2017. Recent brand recalls include an August 27, 2026, recall of the Olympus Tripp-Lite P580-025 DisplayPort Cable for potential video dropout and an August 24, 2026, recall of the Olympus M3 Gold Autoclavable Lateral Telescope 70 for sterilization parameter discrepancies. Other recent recalls of similar products include a January 9, 2026, Lutronic DermaV Laser System recall for patient burn risk and a January 27, 2026, Lutronic CLARITY II Laser System Model 1110200210 recall for sparks and potential patient burns.
How to tell if you have this one
Check for the Soltive Premium Super Pulsed Laser System (TFL-PLS) or Pro Super Pulsed Laser System (TFL-SLS) with Software Version 2.0. These devices were sold for urological procedures and are used in hospitals and clinics.
Brand
Olympus
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Settings
Verify that the laser power setting does not exceed 20W when treating ureteral stones.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2294-2021 (June 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2294-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.