International safety notice

Regarding the products subject to recall, a product that did not meet the required sterility assurance level (SAL) was shipped. It turns out it's possible. We will provide it.

Japan / PMDA Recalls · JPN · Aug 27, 2021

Key facts

Title Regarding the products subject to recall, a product that did not meet the required sterility assurance level (SAL) was shipped. It turns out it's possible. We will provide it.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common Name: Video Flexible Nasolaryngoscope Sales name: Flexible Intubation Video Endoscope SSU
Manufacturer KARL STORZ Endoscopy Japan Co., Ltd.
Models 091361-06
Date Aug 27, 2021
Regulator page info.pmda.go.jp

At a glance

  • No Recall
  • No Field safety notice

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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

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