Ultradent Paper Points Recalled Due to 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 sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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/sterility integrity issue without reported adverse health consequences, fitting the 'Moderate' criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Ultradent Products, Inc. is recalling 62 units of Paper Points, Size 50 PN #1559, 200 per container, sterile. The recall involves lot numbers BCKKP, BD2D4, BD8BY, BDH3Q, and BDTBL. The product is used to remove moisture from the root canal before the obturation procedure begins.
The recall was initiated because the barcode label was placed underneath the sterile barrier and the product was re-wrapped. This error affects the integrity of the sterile barrier, which is critical 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. Healthcare providers and patients should stop using the affected product and contact Ultradent Products, Inc. for further instructions.
The recalled product
- Product
- 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..
- Manufacturer
- Ultradent Products, Inc.
- Affected units
- 62
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 (5)
- Lot numbers BCKKP
- BD2D4
- BD8BY
- BDH3Q
- and BDTBL
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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