Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Presource Procedure Packs containing AAMI Level 3 surgical gowns Recalled by Cardinal Health 200, LLC Due to The kits contained recalled surgical gowns. The gowns...
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 Cardinal Health 200, LLC directly.
Affected Products
Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
Quantity: 2,161,526 units (113, 711 additional units as of 2/25/20)
Why Was This Recalled?
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cardinal Health 200, LLC
Cardinal Health 200, LLC has 275 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report