NanoTips 30g 20pk — Class II medical device recall Z-1034-2017
Terminated recall by Ultradent Products, Inc., reported 2017-01-25, distributed nationwide. Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannu
| Recall number | Z-1034-2017 |
|---|---|
| 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 | 2016-12-14 |
| Classified | 2017-01-17 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-06-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, IT, JP, KR, NL |
| Reason classes | device malfunction |
| Lot numbers | BD6KM |
Product
NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that contain stainless steel 30-gauge cannula to aid in the delivery of chemicals. The NanoTip base is made from a polypropylene copolymer. The stainless steel cannula is made from 304 SS, and is 30-gauge in diameter and 0.488 in length. The cannula is secured in the base with an epoxy adhesive. Indications: Tips, when used in conjunction with the range of available syringes and products, provide a technique that is designed to provide a faster, easier, and more precise delivery. They are designed and created in such a way to generate less product waste and provide optimum control/leverage. Tips are also used for moisture removal and for directing laser light beam. Each of the tips is part of delivery systems designed for dentist-supervised, intra-oral procedures. The NanoTIp is designed for use with dental products manufactured by Ultradent Products, Inc. such as: UltraSeal XT¿ plus, UltraSeal XT¿ hydro, Ultra-Etch¿, PermaFloIdeal for microscopic restorative dentistry
Reason for recall
Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cannula attached to the tip hub may become loose or detach from the blue base that connects to the syringe.
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-1034-2017. 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.