Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
COBRA-OS Recalled by Merit Medical Systems, Inc. Due to Custom sheath Introducer contains incorrect needle size...
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 Merit Medical Systems, Inc. directly.
Affected Products
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Quantity: 1186 units
Why Was This Recalled?
Custom sheath Introducer contains incorrect needle size
Where Was This Sold?
US Distribution to state of: Minnesota
About Merit Medical Systems, Inc.
Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report