Official recall record
Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-08-13
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00821925044111
- Brand on record
- Olympus Corporation of the Americas
What the authority reported
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 to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2026-02-27 · US FDA — Medical Devices
Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/ - 2024-05-31 · US FDA — Medical Devices
Soltive Premium SuperPulsed Laser System, Model TFL-PLS - 2024-01-29 · US FDA — Medical Devices
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
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