Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design Recalled by Stryker Leibinger GmbH & Co. KG Due to An incorrect sterility status on the label, non-sterile...
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 Stryker Leibinger GmbH & Co. KG directly.
Affected Products
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
Quantity: 619
Why Was This Recalled?
An incorrect sterility status on the label, non-sterile products labeled as sterile
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Leibinger GmbH & Co. KG
Stryker Leibinger GmbH & Co. KG has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report