Lower riskMedical device recall · FDA · Published August 13, 2024
Olympus Soltive Laser Recall: Incorrect Bladder Stone Translation Risk
Olympus recalls Soltive Premium SuperPulsed Laser due to incorrect Spanish/Portuguese translation of 'Bladder Stone' as 'Kidney Stone' on the GUI, potentially causing incorrect energy delivery during procedures.
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Take action
Contact the company
📍Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer
Olymp: Olympus is recalling its Soltive Premium SuperPulsed Laser devices because the software incorrectly translates 'Bladder Stone' as 'Kidney Stone' in Spanish and Portuguese. This could lead to delivering the wrong amount of energy during medical procedures, risking patient harm. Read more at govinfonow.com/recall/54237-olympus-soltive-laser-recall-incorrect-bladder-stone-translation-risk.
“Olympus Soltive Laser Recall: Incorrect Bladder Stone Translation Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54237-olympus-soltive-laser-recall-incorrect-bladder-stone-translation-risk. Based on FDA recall #Z-0134-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0134-2025%22&limit=1).
The FDA announced on 2024-08-13 that Olympus Corporation of the Americas is recalling Soltive Premium SuperPulsed Lasers due to a translation error in the graphical user interface. This defect may lead to the delivery of incorrect energy amounts to patients. Owners should contact Olympus for details.
How to tell if you have it
Brand: Olympus
Product: Soltive Premium SuperPulsed Laser
Model/Catalog Number: TFL-PLS
UDI: 00821925044111
Units affected: 1373
The hazard
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone (Clculo renal) on the systems Graphical User Interface. This error presents a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Context
GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since 2017-08-18. Recent recalls include the Olympus Tripp-Lite P580-025 DisplayPort Cable recalled on 2026-08-27 and the Olympus M3 Gold Autoclavable Lateral Telescope 70 recalled on 2026-08-24. Other recent recalls of similar products include the Arrow Pacing PSI Kit Recall (2026-04-21), the Arrow HemoDialysis Kit Recall for Risk of Serious Injuries from Contaminated Drugs (2026-04-21), and the Arrow HemoDialysis Kit Recall for Risk of Serious Injury from Compromised Sterility (2026-04-21).
How to tell if you have this one
Check for the model TFL-PLS with serial numbers listed in the recall notice. The device is intended for surgical procedures involving soft tissue removal.
Brand
Olympus
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Recall number
Product, codes & lots
Quantity
Z-0134-2025
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS; UDI 00821925044111 All Serial Numbers:
1373 units
Z-0135-2025
Soltive Pro SuperPulsed Laser Systems-Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue Model/Catalog Number: TFL-SLS; UDI 00821925044135 All Serial Numbers
159 units
Based on the official FDA remedy
What to do — step by step
Check Device Model
Verify the model number is TFL-PLS and the serial number matches the list provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.” 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 published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-0134-2025 (August 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0134-2025 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.