Straumann USA LLC recalls Emdogain
- Recalling company
- Straumann USA LLC
- Product
- Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
- Reason
- The possibility for this product that is intended for demonstration purposes only to be placed in patients.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 17, 2025
- Reported
- Dec 3, 2025
- Distribution
- US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
- Status
- Ongoing
- Quantity
- 61 units
- Lot / codes
- 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;
- Company location
- Andover, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0582-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0582-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.