W. L. Gore & Associates Inc.

Complete recall history across all FDA and CPSC categories — 4 total recalls

W. L. Gore & Associates Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (4)

FDA medical device enforcement actions by W. L. Gore & Associates Inc.

Date Product Reason Class
Jul 12, 2021 Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXX... Complaints received concerning Balloon Catheter leakage from the guidewire lu... Class II
Jan 6, 2020 GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE) Firm has received reports of leading end catheter component separations. Class II
Jan 6, 2020 GORE¿ EXCLUDER¿ AAA Endoprosthesis Firm has received reports of leading end catheter component separations. Class II
Nov 18, 2019 Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. T... The devices were mislabeled with the incorrect product size resulting in 16Fr... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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