Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STRADIS HEALTHCARE Recalled by Stradis Medical, LLC dba Stradis Healthcare Due to Medical and surgical procedure trays and kits underwent...
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 Stradis Medical, LLC dba Stradis Healthcare directly.
Affected Products
STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
Quantity: 180 units
Why Was This Recalled?
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stradis Medical, LLC dba Stradis Healthcare
Stradis Medical, LLC dba Stradis Healthcare has 93 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report