Z-2505-2024 Class II Ongoing

Recall Details

Soltive Pro SuperPulsed Laser System, Model TFL-SLS

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.

Worldwide distribution - US Nationwide and the countries of Australia, Canada, Chile, Germany, Hong Kong, Japan, Singapore.

Model: TFL-SLS; UDI-DI: 00821925044135; Serial Numbers: All Serial Numbers.

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)