Ultradent Paper Points Size 50 Recall: Barcode Label Under Sterile Barrier
Ultradent recalls sterile Paper Points Size 50 (PN #1559) due to barcode label being placed under sterile barrier, risking contamination during dental procedures.
Lower-risk recall
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Contact the company
What happened, in plain English
Ultradent is recalling sterile Paper Points Size 50 (PN #1559) because the barcode label was placed underneath the sterile barrier and the product was re-wrapped. This could lead to contamination during dental procedures if the product is used without proper sterility. Read more at govinfonow.com/recall/73244-ultradent-paper-points-size-50-recall-barcode-label-under-sterile.
Source Summary by GovInfoNow · govinfonow.com/recall/73244-ultradent-paper-points-size-50-recall-barcode-label-under-sterile · Updated September 19, 2026 · FDA enforcement record: FDA #Z-3218-2017
Cite this page
“Ultradent Paper Points Size 50 Recall: Barcode Label Under Sterile Barrier.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73244-ultradent-paper-points-size-50-recall-barcode-label-under-sterile. Based on FDA recall #Z-3218-2017 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3218-2017%22&limit=1).
Why it’s dangerous
The barcode label was placed underneath the sterile barrier and the product was re-wrapped, which could lead to contamination during dental procedures. This risk exists because the product is used to remove moisture from root canals before dental procedures.
Who’s affected
Dental professionals who use Ultradent Paper Points Size 50 (PN #1559) for root canal procedures are most at risk. Patients using these products during dental treatments may also be affected.
How to tell if you have this one
Check for Ultradent Paper Points Size 50 (PN #1559) with lot numbers BCKKP, BD2D4, BD8BY, BDH3Q, or BDTBL. The product is sold in 200-per-container sterile packages.
- Brand
Ultradent- Category
Medical device
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-3214-2017 | Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 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.; Lot numbers BCDZQ, BCPRC, and BD3MT | 61 units |
| Z-3215-2017 | Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 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.; Lot numbers BD96Z, BDTDM, and BDTQ6 | 95 units |
| Z-3216-2017 | Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 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.; Lot numbers BC8MS, BCBHD, and BDQJ6 | 210 units |
| Z-3217-2017 | 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..; Lot numbers BDB9Q, BDHWK, BDTBJ, and BDX3F | 26 units |
| Z-3218-2017 | Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 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..; Lot numbers BCKKP, BD2D4, BD8BY, BDH3Q, and BDTBL | 62 units |
What to do — step by step
Check Product Lot Number
Identify the lot number on the container to determine if it is in the affected list: BCKKP, BD2D4, BD8BY, BDH3Q, or BDTBL.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is the product used for?
The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3218-2017 (August 4, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3218-2017 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.