Home / Recalls / Olympus Corporation of the Americas / Z-0134-2025

Z-0134-2025 Class II Ongoing

Recalled by Olympus Corporation of the Americas — Center Valley, PA

Recall Details

Product Type
Devices
Report Date
October 30, 2024
Initiation Date
August 13, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1373 units

Product Description

Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS

Reason for Recall

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.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.

Code Information

UDI 00821925044111 All Serial Numbers:

Other recalls by Olympus Corporation of the Americas

  • Z-1694-2026 Class II — Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLT (February 27, 2026)
  • Z-1695-2026 Class II — Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE (February 27, 2026)
  • Z-1639-2026 Class II — Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product N (February 25, 2026)
  • Z-1638-2026 Class II — Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: E (February 25, 2026)
  • Z-1640-2026 Class II — Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Force (February 25, 2026)
  • Z-1644-2026 Class II — Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For (February 25, 2026)
  • Z-1641-2026 Class II — Brand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS C (February 25, 2026)
  • Z-1642-2026 Class II — Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For (February 25, 2026)
  • Z-1643-2026 Class II — Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutt (February 25, 2026)
  • Z-1612-2026 Class II — Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340. (February 12, 2026)