FDA Device recall Z-0582-2026
Emdogain
- FDA Device
- Class II
- ongoing
- Published 2025-12-03
On 2025-12-03 the FDA classified a Class II recall of Emdogain by Straumann Usa, citing the possibility for this product that is intended for demonstration purposes only to be placed in patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0582-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-17 |
| Published | 2025-12-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Straumann Usa |
| Distribution | US |
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.
Identifiers
| code_info | 1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0582-2026%22
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