Z-0412-2016Class II

Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline...

Name: Z-0412-2016 Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline...
Creator: Bestmed, LLC
Published: 2015-11-12
License: https://open.fda.gov/license/

180 Innovations LLC / initiated 2015-11-12 / Terminated / root cause: manufacturing process

FDA source

Bestmed, LLC began a recall of Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medline, Meijer, Premier Value, Safeway, Life Brand, Target, Top... on 2015-11-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0412-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-12
Posted: 2015-12-16
Terminated: 2016-11-30
Recalling firm: 180 Innovations LLC
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.
Product code: FLL Continuous Measurement Thermometer
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified verbally about 11/12/15. Written notification is planed and will include instructions on the identification of the Affected Device, potential health risk, method for return, and manner of restitution for the cost of the Affected Device.
Quantity in commerce: 305,548
Distribution: US Nationwide Distribution and the country of Canada.
Product codes and lots: 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"

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0412-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0412-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-16

Product code FLL

K103617Class IIDigital Forehead ThermometerK-Jump Health Co., Ltd. / cleared 2011-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)