FDA Device recall Z-0412-2016
Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Lif…
- FDA Device
- Class II
- terminated
- Published 2015-12-23
On 2015-12-23 the FDA classified a Class II recall of Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Lif… by Bestmed, citing an incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0412-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-12 |
| Published | 2015-12-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bestmed |
| Distribution | US |
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 installed, a Quick Start Guide, and an Instruction Manual booklet. Product Usage: Device is a handheld thermometer that employs a thermistor sensor intended for people to take a human body temperature at the temporal artery location, the area between the outer corner of the eye and the hairline directly over the temporal artery.
Reason
An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower temperatures than the actual body temperature of the user.
Identifiers
| code_info | Model KD-2201. all lots produced during the 36th week of year 2012 (09/03-07/2012) through and including the 37th week…Model KD-2201. all lots produced during the 36th week of year 2012 (09/03-07/2012) through and including the 37th week of year 2015 (09/07-13/2015). Lot No. S/N: 3612 through S/N: 3715" |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0412-2016%22
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