The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2505-2024·Announced 2024-08-14

Surgical Laser System Recalled Due to Wireless Footswitch Pairing Difficulties

Olympus Corporation is recalling the Soltive Pro SuperPulsed Laser System due to difficulties pairing its wireless footswitch, which could delay surgical procedures. The recall affects 253 units worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class II recall. No illnesses, injuries, or hospitalizations have been reported. The hazard is a functional defect (wireless pairing difficulty) that could delay procedures but does not pose direct patient harm. This qualifies as a Moderate (Score 2) recall.

Plain-English summary

Olympus Corporation of the Americas is recalling the Soltive Pro SuperPulsed Laser System, Model TFL-SLS. The recall is due to difficulties in pairing the wireless footswitch with the laser system, which could potentially delay surgical procedures.

The recalled product includes all serial numbers of the Soltive Pro SuperPulsed Laser System, Model TFL-SLS. A total of 253 units have been distributed worldwide, including distribution in the United States and internationally to Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore.

Healthcare facilities and surgical centers using this equipment should contact Olympus Corporation of the Americas regarding the wireless footswitch pairing issue and request information about available remedies or replacement devices. No patient injuries have been reported in connection with this recall.

The recalled product

Product
Soltive Pro SuperPulsed Laser System, Model TFL-SLS
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Laser
Hazard
Affected units
253

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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