Z-1034-2017Class II

NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that...

Name: Z-1034-2017 NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal blue tips that...
Creator: Ultradent Products, Inc.
Published: 2016-12-14
License: https://open.fda.gov/license/

Ultradent Products Inc. / initiated 2016-12-14 / Terminated / root cause: design

FDA source

Ultradent Products, Inc. began a recall of 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... on 2016-12-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1034-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-14
Posted: 2017-01-17
Terminated: 2017-06-05
Recalling firm: Ultradent Products Inc.
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
Product code: EID Syringe, Restorative And Impression Material
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.
Root cause tag: design
FDA root cause: Device Design
Action: Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated December 14, 2016, to all affected consignees. The letter instructed consignees to discard remaining inventory and return the response form. For any questions, please call at 801-553-4858.
Quantity in commerce: 143 packs of 100 tips; 104 packs of 20 tips
Distribution: Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan.
Product codes and lots: Lot Numbers: BD6KM, BCVPG, BCTBY, BD3K4, BCWVZ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1034-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1034-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-17

Product code EID

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)