Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 25, 2017
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
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 b…
Ultradent Products, Inc. recalled NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal … — a moderate-severity action.
NanoTips 30g 20pk, 100pk PN 1240, 1426 Description: NanoTips are injection molded royal … was recalled by Ultradent Products, Inc. in January 25, 2017. Reason: Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cann…. Check the official notice for the remedy. Verify recall #Z-1034-2017 with the FDA Devices before acting.
The recall
Ultradent Products, Inc. issued this moderate-severity FDA Devices recall — Ultradent Products, Inc. announces a voluntary field action for the NanoTips 30g 20pk, 100pk because the cann….
- Moderate
- severity level
- Class II
- classification
- January 25, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1034-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1034-2017) was formally reported on January 25, 2017, with the manufacturer initiating the action on December 14, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Ultradent Products, Inc. is listed as the recalling firm, operating out of South Jordan, UT. Federal records list the affected scope as 143 packs of 100 tips; 104 packs of 20 tips.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
143 packs of 100 tips; 104 packs of 20 tips
Related Recalls
6
6 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1034-2017 |
| Date reported | January 25, 2017 |
| Date initiated | December 14, 2016 |
| Recalling firm | Ultradent Products, Inc. |
| Firm location | South Jordan, UT |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1034-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ultradent Products, Inc.. Units affected: 143 packs of 100 tips; 104 packs of 20 tips.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1034-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US (Nationwide) - Internationally to Belgium, Switzerland, Germany, Italy, South Korea, Netherlands, and Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1034-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 25, 2017.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.