FDA Device recall Z-3218-2017
Ultradent Products, Inc
- FDA Device
- Class II
- terminated
- Published 2017-10-04
On 2017-10-04 the FDA classified a Class II recall of Ultradent Products, Inc by Ultradent Products, citing the barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3218-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-08-04 |
| Published | 2017-10-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ultradent Products |
| Distribution | US |
Product
Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 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
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Identifiers
| code_info | Lot numbers BCKKP, BD2D4, BD8BY, BDH3Q, and BDTBL |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3218-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.