Olympus Corporation of the Americas 2024-01-24 Health serious FDA
Health · FDA · Recall #FDA-Z-0716-2024
Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150,… Recall
Issued January 24, 2024 · Olympus Corporation of the Americas
In January 2024, Olympus Corporation of the Americas recalled the Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150,…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.
What you should do
- 1 Stop using Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Olympus Corporation of the Americas to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Olympus Corporation of the Americas
- Category
- Health
- Recall date
- January 24, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide. Global Distribution
- Recall number
- FDA-Z-0716-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Olympus Corporation of the Americas has 42 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.