FDA Medical devices recall ·
Soltive Premium SuperPulsed Laser - Intended for incision, excision… recall
- Recall number
- Z-0134-2025
- Date
- (initiated August 13, 2024)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1373 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI 00821925044111 All Serial Numbers:
Distribution
Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
States: California Delaware
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0134-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.