Ultradent Paper Points Recalled Due to Sterile Barrier Labeling Error
Ultradent Products, Inc. is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier and the product was re-wrapped.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a packaging/labeling error (barcode under sterile barrier) without reported injuries or illnesses, fitting the criteria for moderate severity involving low-risk contamination or labeling issues.
Plain-English summary
Ultradent Products, Inc. is recalling 26 units of Paper Points, Size 45 PN #1558, 200 per container, sterile. The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins. The recall involves lot numbers BDB9Q, BDHWK, BDTBJ, and BDX3F.
The recall was initiated because the barcode label was placed underneath the sterile barrier and the product was re-wrapped. This packaging error affects the integrity of the sterile barrier.
Distribution was nationwide and included foreign distribution to Canada, Bulgaria, Namibia, New Zealand, and Germany. There was no military or government distribution. Consumers and healthcare providers should stop using the affected product and contact Ultradent Products, Inc. for instructions on return or replacement.
The recalled product
- Product
- 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..
- Manufacturer
- Ultradent Products, Inc.
- Category
- Medical Device — Dental Supplies
- Affected units
- 26
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 (4)
- Lot numbers BDB9Q
- BDHWK
- BDTBJ
- and BDX3F
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Ultradent Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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