Ultradent Products — Class II medical device recall Z-3215-2017
Terminated recall by Ultradent Products, Inc., reported 2017-10-04, distributed nationwide. The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
| Recall number | Z-3215-2017 |
|---|---|
| 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 | 2017-08-04 |
| Classified | 2017-09-26 |
| Reported by FDA | 2017-10-04 |
| Terminated | 2018-01-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | BG, CA, DE, NZ |
| Quantity | 95 units |
| Reason classes | labeling, sterility |
| Lot numbers | BD96Z |
Product
Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Reason for recall
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
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-3215-2017. 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.