Ultradent Paper Points Recalled for Sterile Barrier Labeling Error
Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, compromising the product's sterile status.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging/labeling error that compromises sterility, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ultradent Products, Inc. is recalling 61 units of Paper Points, Size 20 PN #1560, 200 per container, sterile. The recall involves lot numbers BCDZQ, BCPRC, and BD3MT. The product is used to remove moisture from root canals before obturation procedures.
The recall was initiated because the barcode label was placed underneath the sterile barrier and the product was re-wrapped. This error compromises the integrity of the sterile barrier, which is essential for the product's intended use in dental procedures.
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 products and contact Ultradent Products, Inc. for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Ultradent Products, Inc.
- Category
- Medical Device — Dental Supplies
- Affected units
- 61
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 (3)
- Lot numbers BCDZQ
- BCPRC
- and BD3MT
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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