Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit Recalled by Vygon U.S.A. Due to Compromised sterile barriers due to the Tyvek Lid...
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 Vygon U.S.A. directly.
Affected Products
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Quantity: 8,320 units
Why Was This Recalled?
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Vygon U.S.A.
Vygon U.S.A. has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report