CLASS II Device recall · Reported 4 Oct 2017 · FDA Enforcement Report
Paper Points, Size 45 PN #1558, 200 per container, sterile recalled
Ultradent Products is recalling Paper Points, Size 45 PN #1558, 200 per container, sterile, distributed nationwide in the US. The recall was initiated on 4 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3217-2017
- FDA event ID
- 77891
- Recalling firm
- Ultradent Products, South Jordan, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Aug 2017
- FDA classified
- 26 Sep 2017
- Reported
- 4 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 4 Aug 2017 | Recall initiated by company | |
| 26 Sep 2017 | Classified by FDA | +53 days |
| 4 Oct 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 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..
Where it was distributed
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
Questions about this recall
Why was it recalled?
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Which lots are affected?
Lot numbers BDB9Q, BDHWK, BDTBJ, and BDX3F
Where was it sold?
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 77891This product is part of a recall event; the main page for the event is Paper Points, Size 50 PN #1559, 200 per container, sterile recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Paper Points, Size 50 PN #1559, 200 per container, sterile recalled | Ultradent Products | Sterility | Nationwide | |
| CLASS II | Paper Points, Size 25 PN #1554, 200 per container, sterile recalled | Ultradent Products | Sterility | Nationwide | |
| CLASS II | Paper Points, Size 20 PN #1560, 200 per container, sterile recalled | Ultradent Products | Sterility | Nationwide | |
| CLASS II | Paper Points, Size 30 PN #1555, 200 per container, sterile recalled | Ultradent Products | Sterility | Nationwide |
More recalls from Ultradent Products
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|---|---|---|---|---|---|
| Device | CLASS II | Jiffy Original Composite Polisher Cups (Coarse) recalled | Ultradent Products | Device Malfunction | 31 states |
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| Device | CLASS II | Transcend Econo Kit (UB) - Singles recalled by Ultradent Products | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Transcend Singles Universal Body (UB) Refill recalled | Ultradent Products | Particulate Matter | 35 states |
| Device | CLASS II | Peak Universal Bond Self-Etch Bottle Kit, Part recalled | Ultradent Products | Other | Nationwide |
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