SOLTIVE SuperPulsed Laser Fibers recalled for model and size labeling mismatch
Olympus is recalling certain SOLTIVE SuperPulsed Laser Fibers because device model and size may be mismatched between packaging and the actual device. This could result in the wrong laser fiber being used in medical 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving labeling mismatch on a medical device used in surgical procedures. While no injuries or illnesses have been reported, the model and size mismatch could result in the wrong laser fiber being used, creating a potential risk of harm during medical procedures.
Plain-English summary
Olympus Corporation of the Americas is recalling certain SOLTIVE SuperPulsed Laser Fibers used in medical procedures. The affected products include models TFL-FBX150BS, TFL-FBX200S, TFL-FBX200BS, TFL-FBX550S, and TFL-FBX365S. Approximately 190 cartons containing 950 laser fiber units have been distributed.
The device model and size may be mismatched between the product's carton, the immediate pouch packaging, and the device itself. This mislabeling could lead to medical personnel selecting and using an incorrect laser fiber during surgical or therapeutic procedures.
The affected laser fibers have been distributed nationwide in the United States as well as internationally.
The recalled product
- Product
- SOLTIVE SuperPulsed Laser Fibers, Model# Labeled TFL-FBX150BS (Carton) - 150 Micron Ball Tip Single Use Fiber Model # Labeled TFL-FBX200S (Pouch) - 200 Micron Single Use Fiber Model # Labeled TFL-FBX200BS (Carton) - 200 Micron Ball Tip Single Use Fiber Model # Labeled…
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Laser Fibers
- Hazard
Distribution
Distributed nationwide across the United States.
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