3M ESPE Imprint II Regular Body — Class II medical device recall Z-0535-2014
Terminated recall by 3M Company - Health Care Business, reported 2013-12-25, distributed nationwide. Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moist
| Recall number | Z-0535-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | 3M Company - Health Care Business, Saint Paul, MN, United States |
| Recall initiated | 2013-11-21 |
| Classified | 2013-12-18 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-06-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, FR, HK, IT, JP, KR, MX |
| Quantity | 1,977 kits |
| Lot numbers | N510884, N510889, N511952 |
| Model numbers | 5315, 9379 |
Product
3M ESPE Imprint II Regular Body , Catalog Number 9379, and Paradigm Regular Body VPS, Catalog Number 5315, Impression Material that are intended to reproduce the structure of a patients teeth. Impression Materials are composed of hydrophilic vinyl polysiloxane impression materials, designed for making precise crown and bridge, inlay, onlay, veneer preparations, removable denture and partial denture impressions.
Reason for recall
Specific lots of Imprint II and Paradigm impression material refill packs are being recalled because the moisture displacement feature in both is greatly reduced which may impact the quality of the dental impression.
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-0535-2014. 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.