FDA recall Z-1633-2023

Product

Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20

Reason for recall

There have been reports of skin burns to children wearing the device.

Distribution

US Nationwide distribution.

Key facts

Status

Terminated

Initiation date

2023-05-10

Report date

2023-06-14

Termination date

2024-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1633-2023