Emdogain — Class II medical device recall Z-0582-2026
Ongoing recall by Straumann USA LLC, reported 2025-12-03, distributed nationwide. The possibility for this product that is intended for demonstration purposes only to be placed in patients.
| Recall number | Z-0582-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Straumann USA LLC, Andover, MA, United States |
| Recall initiated | 2025-10-17 |
| Classified | 2025-11-21 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Quantity | 61 units |
| Lot numbers | CRL56, EPZM8, HPHJ1, HPT6, KEWN9, NAAM6, VAW80 |
Product
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Reason for recall
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0582-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.