Wireless Footswitch for Soltive Laser System Recalled for Pairing Difficulties
Olympus Corporation of the Americas is recalling 1,838 units of the Soltive SuperPulsed Laser System Wireless Footswitch due to pairing difficulties that may delay surgical procedures.
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: This is a FDA Class II recall for a functional pairing failure with no reported illnesses, injuries, or deaths. The hazard is operational rather than a direct safety risk, affecting surgical scheduling rather than patient safety.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,838 units of the Soltive SuperPulsed Laser System Wireless Footswitch (Model TFL-AFSWL). The wireless footswitch may encounter difficulties when attempting to pair with the Soltive Laser system.
Pairing difficulties may delay surgical procedures that rely on the wireless footswitch. The recall affects all units with this model number.
The affected devices were distributed worldwide, including throughout the United States and in Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore.
Users should verify that the wireless footswitch properly pairs with the Soltive Laser system before performing procedures. For assistance, contact Olympus Corporation of the Americas.
The recalled product
- Product
- Soltive SuperPulsed Laser System Wireless Footswitch, Model TFL-AFSWL
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 1,838
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-AFSWL
- UDI-DI: 00821925044258
- 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.
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