Temporary Dental Fillings Recalled Due to Improper Storage Conditions
Family Dollar is recalling DENTEMP ONE STEP temporary dental fillings sold between June 2023 and October 2023 in 22 states because they were stored outside labeled temperature requirements, which may affect product performance.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The hazard—improper storage conditions—creates a risk that the temporary dental filling may not perform as intended, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Family Dollar Stores, LLC, is recalling DENTEMP ONE STEP .077OZ temporary dental filling products (SKU 902139) because they were stored outside of labeled temperature requirements. A total of 329,044 units were affected.
The affected products were distributed to Family Dollar stores in the following states: Georgia, Alabama, Mississippi, Florida, Louisiana, Arkansas, Arizona, Kansas, Texas, Oklahoma, Colorado, New Mexico, Nebraska, Utah, Nevada, Wyoming, Idaho, South Dakota, North Dakota, California, Montana, Oregon, and Washington. The affected units were sold between June 1, 2023 and October 4, 2023.
Improper storage conditions can compromise the integrity and performance of the temporary dental filling product.
The recalled product
- Product
- DENTEMP ONE STEP .077OZ, SKU 902139
- Manufacturer
- Family Dollar Stores, Llc.
- Affected units
- 329,044
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)
- All units sold at stores between June 1
- 2023 and October 4
- 2023.
Distribution
Part of a larger recall action
This product is one of 10 recalled by Family Dollar Stores, Llc. 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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