Olympus Corporation of the Americas 2026-02-11 Health serious FDA
Health · FDA · Recall #FDA-Z-1290-2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 … Recall
Issued February 11, 2026 · Olympus Corporation of the Americas
In February 2026, Olympus Corporation of the Americas recalled the Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 …, 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
Devices which did not undergo thermoforming could deform and lose performance.
What you should do
- 1 Stop using Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 … 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
- February 11, 2026
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI
- Recall number
- FDA-Z-1290-2026
- 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 356th Health recall we've logged in 2026.