FLEXCERA SMILE -a Dental resins for the fabrication of artificial… — Class II medical device recall Z-0643-2022
Ongoing recall by Envisiontec US Llc, reported 2022-02-23, distributed nationwide. Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
| Recall number | Z-0643-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Envisiontec US Llc, Dearborn, MI, United States |
| Recall initiated | 2022-01-06 |
| Classified | 2022-02-15 |
| Reported by FDA | 2022-02-23 |
| Distributed | Nationwide (US) |
| Quantity | 795 units |
| Reason classes | labeling |
| Lot numbers | 010421, 010921A, 010921B, 020621, 020821A, 020821B, 020821C, 020921A, 020921B, 030521, 030621, 030821A, 030821B, 030821C, 030921A, 030921B, 040521A, 040521B, 040521C, 050721A, 050721B, 050721C, 050721D, 060421-A, 060421-B, 060421-C, 060721A, 060721B, 060721C, 060721D, 070421-A, 070421-B, 070421-C, 070621A, 070621B, 070621C, 070721A, 070721B, 070721C, 070721D and 186 more |
Product
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Reason for recall
Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin
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-0643-2022. 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.