Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Aesculap Sterile disposable fleece drape Recalled by Aesculap Implant Systems LLC Due to Packaging seal integrity not validated resulting in a...
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 Aesculap Implant Systems LLC directly.
Affected Products
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Quantity: 4500 pieces
Why Was This Recalled?
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Where Was This Sold?
This product was distributed to 14 states: CA, CO, GA, IL, IN, KY, MI, NE, NY, NC, OH, RI, VA, WI
About Aesculap Implant Systems LLC
Aesculap Implant Systems LLC has 61 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report