Digital Temple Thermometer labeled under: Bestmed — Class II medical device recall Z-0412-2016
Terminated recall by Bestmed, LLC, reported 2015-12-23, distributed nationwide. An incorrect calibration of the thermometer that causes the device to display inaccurate and frequently lower
| Recall number | Z-0412-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bestmed, LLC, Golden, CO, United States |
| Recall initiated | 2015-11-12 |
| Classified | 2015-12-16 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2016-11-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 305,548 |
| Model numbers | KD-2201 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0412-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.