Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sterile Custom Packs to be used in surgical procedures. Recalled by American Contract Systems Due to The surgical gowns were manufactured in a facility...
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 American Contract Systems directly.
Affected Products
Sterile Custom Packs to be used in surgical procedures.
Quantity: 2,868 total kits
Why Was This Recalled?
The surgical gowns were manufactured in a facility that is not registered by the FDA.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Contract Systems
American Contract Systems has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report