PCA 4000 Curing Units — Class II medical device recall Z-0746-2022
Ongoing recall by Envisiontec US Llc, reported 2022-03-16, distributed nationwide. The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
| Recall number | Z-0746-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Envisiontec US Llc, Dearborn, MI, United States |
| Recall initiated | 2022-01-20 |
| Classified | 2022-03-10 |
| Reported by FDA | 2022-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 172 units |
Product
PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers.
Reason for recall
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
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-0746-2022. 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.