International safety notice
For the products subject to recall, we were unable to obtain sufficient proof in the verification of the resterilization method. We have come to the conclusion that this is a product whose safety cannot be guaranteed. We will carry out a voluntary recall to prevent the risk of contamination.
Japan / PMDA Recalls · JPN · Apr 3, 2024
Key facts
| Title | For the products subject to recall, we were unable to obtain sufficient proof in the verification of the resterilization method. We have come to the conclusion that this is a product whose safety cannot be guaranteed. We will carry out a voluntary recall to prevent the risk of contamination. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Reusable endoscopic non-active instrument Sales name: Laser guide |
| Manufacturer | KARL STORZ Endoscopy Japan Co., Ltd. |
| Models | 461000 |
| Date | Apr 3, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 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