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.
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 describes a packaging/labeling error without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ultradent Products, Inc. is recalling sterile Paper Points, Size 30 PN #1555, 200 per container. The product is used to assure that all moisture is removed 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 packaging error may compromise the sterile integrity of the product.
The affected lots are BC8MS, BCBHD, and BDQJ6. A total of 210 units were distributed nationwide and to Canada, Bulgaria, Namibia, New Zealand, and Germany. There was no military or government distribution. Consumers and healthcare providers should stop using the product and contact Ultradent Products, Inc. for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Ultradent Products, Inc.
- Affected units
- 210
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 BC8MS
- BCBHD
- and BDQJ6
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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