Darby Dental Prophylaxis Paste Mislabeled with Incorrect Part Number
Young Dental Manufacturing is recalling 534 units of Darby Prophylaxis Paste with 1.23% Fluoride Ion (Lot 248607) due to incorrect part number labeling. The product was labeled as part number 045032 instead of the correct 040032.
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: This is an FDA Class II recall involving a labeling error. No illnesses or injuries have been reported. The hazard is primarily a documentation and product identification issue, fitting the rubric criterion for minor labeling errors.
Plain-English summary
Young Dental Manufacturing is recalling 534 units of Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse (Lot 248607) due to incorrect labeling. The affected units were labeled with part number 045032 instead of the correct part number 040032. This labeling error may prevent proper product identification.
The recalled product is a dental prophylaxis paste used by dental professionals during routine cleaning procedures. Distribution occurred in Tennessee.
Dental professionals and consumers in possession of the affected product should verify the lot number (248607) and check for the incorrect part number (045032) on the label. If found, the product should be identified as part number 040032 for proper record-keeping. Users with questions should contact Young Dental Manufacturing.
The recalled product
- Product
- Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse
- Manufacturer
- Young Dental Manufacturing I, LLC
- Hazard
- Affected units
- 534
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 (2)
- Unique Device Identifier (UDI)1: 00889813036273
- Lot: 248607
Distribution
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