Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Class I - Dangerous

🏥 Medical Devices Recalled: October 17, 2025 Straumann USA Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Straumann USA LLC
Reason for Recall:: The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Product Codes/Lot Numbers:

1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;