High FDA (Devices)·Z-1034-2017·Announced 2017-01-25

Ultradent NanoTips 30g Dental Tips Recalled for Loose Cannula

Ultradent Products, Inc. is recalling NanoTips 30g dental tips because the stainless steel cannula may detach from the base, posing a risk during intra-oral procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a component may detach during use, creating a risk of harm (injury or foreign object retention) even though no specific injuries are reported in the source text.

Plain-English summary

Ultradent Products, Inc. is conducting a voluntary field action for NanoTips 30g 20pk and 100pk (Part Numbers 1240 and 1426). The recall is due to a defect where the stainless steel cannula attached to the tip hub may become loose or detach from the blue polypropylene base that connects to the syringe.

The affected products are dental tips designed for dentist-supervised, intra-oral procedures to aid in the delivery of chemicals, moisture removal, and directing laser light beams. The recall covers 143 packs of 100 tips and 104 packs of 20 tips. The affected lot numbers are BD6KM, BCVPG, BCTBY, BD3K4, and BCWVZ.

Distribution was worldwide, including the United States (nationwide) and internationally to Belgium, Switzerland, Germany, Italy, South Korea, the Netherlands, and Japan. Consumers and dental professionals should stop using the affected NanoTips and contact Ultradent Products, Inc. for instructions on return or replacement.

The recalled product

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
Manufacturer: Ultradent Products, Inc.
Category: Medical Device — Dental Instruments
Hazard: detachment
foreign-object

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Lot Numbers: BD6KM
BCVPG
BCTBY
BD3K4
BCWVZ

Distribution

Distributed nationwide across the United States.

Same manufacturer · Ultradent Products, Inc.

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