Olympus Laser Fiber Stripper Recall Due to Sterilization Validation Gap
Olympus recalls fiber stripper models sold before 2023 lacking validated sterilization instructions, creating a contamination risk when used on sterile medical fibers.
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 a risk-of-harm medical device with no reported injuries, fitting the High category per the severity rubric. The lack of validated sterilization instructions for equipment labeled as autoclavable creates a material patient safety risk in sterile medical procedures.
Plain-English summary
Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser System TFL Fiber Stripper units (Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940) sold prior to 2023. Approximately 3,001 units have been distributed nationwide and globally.
The recalled devices are supplied non-sterile and labeled as reusable and autoclavable. However, Olympus has not established or validated cleaning and sterilization instructions for these devices. Use of non-sterile fiber strippers or cleavers on sterile fibers poses a risk of contamination that could compromise medical procedures.
The recalled product
- Product
- Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,001
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 (1)
- Lot Number: All units sold prior to 2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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