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Vygon U.S.A.

Complete recall history across all FDA and CPSC categories — 11 total recalls

Vygon U.S.A. 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 (11)

FDA medical device enforcement actions by Vygon U.S.A.

Date Product Reason Class
Apr 15, 2021 Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit... Compromised sterile barriers due to the Tyvek Lid not properly adhering to th... Class II
Dec 6, 2018 Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002-... DualStop Caps defect causing leaks in affected product Class II
Dec 6, 2018 Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - ... DualStop Caps defect causing leaks in affected product Class II
Feb 28, 2018 PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PI... Potential friction holes may affect the sterility of the product. Class II
Feb 28, 2018 Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the ins... Potential friction holes may affect the sterility of the product. Class II
Feb 28, 2018 PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the in... Potential friction holes may affect the sterility of the product. Class II
Feb 28, 2018 Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insert... Potential friction holes may affect the sterility of the product. Class II
Feb 28, 2018 Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the ins... Potential friction holes may affect the sterility of the product. Class II
Feb 28, 2018 Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit f... Potential friction holes may affect the sterility of the product. Class II
Feb 28, 2018 PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the in... Potential friction holes may affect the sterility of the product. Class II
Feb 28, 2018 PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of ... Potential friction holes may affect the sterility of the product. 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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