Bestmed Digital Temple Thermometers Recalled for Inaccurate Temperature Readings
Bestmed is recalling 305,548 digital temple thermometers sold under multiple retail brands because they display inaccurate, frequently lower temperatures than actual body temperature.
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: The recall involves a medical device with a defect that could lead to incorrect health assessments, but no injuries or illnesses have been reported, fitting the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bestmed, LLC is recalling 305,548 digital temple thermometers (Model KD-2201) that were distributed nationwide in the United States and in Canada. The devices are sold under various retail brand names, including Bestmed, Good Neighbor, Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, and Western Family. The affected units were produced during the 36th week of 2012 through the 37th week of 2015, with serial numbers ranging from 3612 to 3715.
The recall was initiated because the thermometers have an incorrect calibration that causes them to display inaccurate and frequently lower temperatures than the actual body temperature of the user. This defect could lead to incorrect health assessments based on the device's readings.
Consumers who purchased these thermometers should stop using them and contact Bestmed, LLC for further instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top Care, Best Choice, Western Family. Device is packaged in plastic blister with cardboard insert, 2 AAA batteries…
- Manufacturer
- Bestmed, LLC
- Category
- Medical Device — Thermometer
- Affected units
- 305,548
Distribution
Distributed nationwide across the United States.
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