Straumann USA recalled 61 units of Emdogain on October 17, 2025. The product, intended for demonstration only, poses a risk if used on patients. Consumers must stop using the affected products immediately.
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Straumann USA LLC or your healthcare provider for instructions. Notification method: Letter
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Emdogain, Article Numbers 440.230V10 and 475.132V10, was distributed nationwide in states including Arizona, California, and Florida. The product is classified as Class II medical devices.
The recall stems from the risk of Emdogain being used on patients, contrary to its intended purpose. Misuse of this product could lead to serious health complications.
No specific injuries or incidents have been reported related to this recall. The manufacturer advises healthcare providers to cease use immediately.
Stop using the product immediately. Follow the recall instructions provided by Straumann USA. Contact the manufacturer or your healthcare provider for further instructions.
For more information, contact Straumann USA LLC or visit the FDA website for recall instructions at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0582-2026.
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