IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1 — Class II medical device recall Z-0292-2019
Terminated recall by CMP Industries, Llc, reported 2018-11-07, distributed nationwide. Foreign material in product
| Recall number | Z-0292-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CMP Industries, Llc, Albany, NY, United States |
| Recall initiated | 2018-09-12 |
| Classified | 2018-10-30 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, ES |
| Quantity | 400 units |
| Reason classes | foreign material |
| Lot numbers | 85623, 85827 |
| Model numbers | 3306 |
Product
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Reason for recall
Foreign material in product
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-0292-2019. 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.