Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
SOLOPATH Re-Collapsible Access System Recalled by Terumo Medical Corporation Due to There is a potential for dislodgement of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Terumo Medical Corporation directly.
Affected Products
SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
Quantity: 1431
Why Was This Recalled?
There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Terumo Medical Corporation
Terumo Medical Corporation has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report