Olympus Corporation of the Americas: Medical Device Recall in 2021 - (Recall #: Z-2294-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Soltive Premium Super Pulsed Laser System (TFL-PLS) & Pro Super Pulsed Laser System (TFL-SLS). Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in urology, lithotripsy, gastroenterological surgery and gynecological surgery

Product Classification:

Class II

Date Initiated: June 30, 2021

Date Posted: August 25, 2021

Recall Number: Z-2294-2021

Event ID: 88229

Reason for Recall:

Thermal injury following dusting and fragmenting treatment of ureteral stones when user exceeded the 20W standard presets

Status: Terminated

Product Quantity: 408 units

Code Information:

Software Version 2.0 (all serial numbers)

Distribution Pattern:

US Nationwide Distribution Foreign: Canada Australia Japan Hong Kong Europe Singapore

Voluntary or Mandated:

Voluntary: Firm initiated