Ultradent Paper Points Recalled Due to Sterile Barrier Label Placement
Ultradent Products is recalling sterile Paper Points because the barcode label was placed underneath the sterile barrier, potentially compromising sterility.
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 hospitalizations, injuries, or illnesses. The hazard is a potential compromise of sterility due to packaging error, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ultradent Products, Inc. is recalling 95 units of sterile Paper Points, Size 25 PN #1554, 200 per container. The product is used to remove moisture from root canals before the obturation procedure. The recall was initiated because the barcode label was placed underneath the sterile barrier and the product was re-wrapped, which may have compromised the sterile integrity of the packaging.
The affected lot numbers are BD96Z, BDTDM, and BDTQ6. Distribution was nationwide and included foreign shipments to Canada, Bulgaria, Namibia, New Zealand, and Germany. There was no military or government distribution.
Healthcare providers and consumers should stop using these products and contact Ultradent Products, Inc. for instructions on return or replacement.
The recalled product
- Product
- 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.
- Manufacturer
- Ultradent Products, Inc.
- Affected units
- 95
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 BD96Z
- BDTDM
- and BDTQ6
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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