Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gore DrySeal Flex Introducer Sheath Recalled by W. L. Gore & Associates Inc. Due to Mislabeling
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 W. L. Gore & Associates Inc. directly.
Affected Products
Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ.
Quantity: 141 devices
Why Was This Recalled?
The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices.
Where Was This Sold?
All distribution is foreign to the following countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Norway, Spain, Sweden, Switzerland, and the UK.
About W. L. Gore & Associates Inc.
W. L. Gore & Associates Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report