InterGuard 5 — Class II medical device recall Z-0583-2016
Terminated recall by Ultradent Products, Inc., reported 2016-01-13, distributed nationwide. Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from
| Recall number | Z-0583-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ultradent Products, Inc., South Jordan, UT, United States |
| Recall initiated | 2015-12-22 |
| Classified | 2016-01-04 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-10-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CO, DE, DK, FR, GB, IS, PT |
| Quantity | 157 |
| Lot numbers | BC2GN, BC4L7 |
| Model numbers | 4012 |
Product
InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.
Reason for recall
Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.
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-0583-2016. 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.