International safety notice

This product is an insole made of vegetable carbon fiber whose main purpose is to promote blood circulation. This time, it was discovered that the product had been shipped to the market before the manufacturer had determined whether or not it could be released on the market. We have decided to make a collection.

Japan / PMDA Recalls · JPN · Jan 27, 2022

Key facts

Title This product is an insole made of vegetable carbon fiber whose main purpose is to promote blood circulation. This time, it was discovered that the product had been shipped to the market before the manufacturer had determined whether or not it could be released on the market. We have decided to make a collection.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: Home heating pack Sales name: Heat treatment insole
Manufacturer ICST Co., Ltd.
Models 20210427, 20210628, 20201107, 20210309, 20210128, 20210414, 20210810, 20210129, 20210126, 20201027, 20200609, 20201029 and 31 more
Date Jan 27, 2022
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices