The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0134-2025·Announced 2024-10-30

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units
1,373

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.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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