Olympus Soltive Premium SuperPulsed Laser Recalled for Translation Labeling Error
Olympus recalled 1,373 Soltive Premium SuperPulsed Lasers due to incorrect GUI translations of 'Bladder Stone' to 'Kidney Stone' in Spanish and Portuguese, potentially causing incorrect energy delivery to patients.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a FDA Class II medical device recall where a translation error could cause incorrect energy delivery to patient anatomy. No injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not been reported receive a High (3) severity rating.
Plain-English summary
Olympus Corporation of the Americas is recalling the Soltive Premium SuperPulsed Laser, Model/Catalog Number TFL-PLS, a medical device intended for surgical incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue. A total of 1,373 units have been distributed worldwide.
The recall was initiated due to a translation error in the device's graphical user interface. In Spanish and Portuguese versions of the system, the term 'Bladder Stone' was incorrectly translated to 'Kidney Stone.' This mislabeling creates a potential for the device to deliver an incorrect or unintended amount of energy to the patient's anatomy.
The affected devices are distributed in the United States and internationally in Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore. All serial numbers of Model TFL-PLS are included in this recall.
The recalled product
- Product
- Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Surgical Laser
- Hazard
- translation-error
- incorrect-energy-delivery
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI 00821925044111 All Serial Numbers:
Distribution
Distributed nationwide across the United States.
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