FDA Medical devices recall ·
Emdogain recall
- Recall number
- Z-0582-2026
- Date
- (initiated October 17, 2025)
- Company / brand
- Straumann USA LLC
60 Minuteman Rd, Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 61 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Why was it recalled?
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
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;
Distribution
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
States: Arizona California Delaware Florida Idaho Missouri Tennessee Texas Utah Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0582-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.