International safety notice

We received a report from an overseas manufacturer that the clip could not be removed from the forceps when using the product in the overseas market, and we investigated the issue. After conducting an investigation, we found that we could not completely deny the possibility that the incident occurred in products with similar structures, so we decided to We decided to carry out the main collection. Furthermore, we have not received any reports of malfunctions or health damage related to this event in Japan.

Japan / PMDA Recalls · JPN · Oct 19, 2023

Key facts

Title We received a report from an overseas manufacturer that the clip could not be removed from the forceps when using the product in the overseas market, and we investigated the issue. After conducting an investigation, we found that we could not completely deny the possibility that the incident occurred in products with similar structures, so we decided to We decided to carry out the main collection. Furthermore, we have not received any reports of malfunctions or health damage related to this event in Japan.
Regulator Japan / PMDA Recalls
Country JPN
Brand Common name: medical forceps Sales name: D-clip forceps
Manufacturer TKB Co., Ltd.
Models W591577, W591684, CP35.410, U587031, 210mm, X592627, 190mm, X592812, 35.410, U587209, 230mm, W591456 and 5 more
Date Oct 19, 2023
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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