Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
REF/Catalogue Number GSX0030A Recalled by W L Gore & Associates, Inc. Due to Septal Occluders contain the incorrect expiration date. Product...
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
REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
Quantity: 2,238 units
Why Was This Recalled?
Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
Where Was This Sold?
This product was distributed to 47 states: AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, DC
About W L Gore & Associates, Inc.
W L Gore & Associates, Inc. has 21 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report