Emdogain (Straumann) – Unintended Patient Use Risk (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Brand
Straumann USA LLC
Lot Codes / Batch 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
Products Sold
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;
Straumann USA LLC is recalling Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; due to The possibility for this product that is intended for demonstration purposes only to be placed in patients.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Recommended Action
Per FDA guidance
On October 17, 2025 Urgent Field Safety Action letters were sent to customers. Action to be taken: 1. 1. Check your inventory for the affected article/lot numbers. If the article is still in your inventory, then stop use/ distribution of the product immediately and quarantine / segregate physically. Please return the affected items to the attention of Jennifer Jackson at Straumann USA, LLC for credit as indicated on the Customer Confirmation Form. 2. 2. In all cases, complete and return the enclosed Customer Confirmation Form with the affected product using the return UPS label provided. Transmission of the Field Safety Notice This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. The Food and Drug Administration (FDA) has been informed about this Field Safety Corrective Action. We apologize for any inconvenience that this may cause.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026