International safety notice
Some of the sterilization packs used for some products lack the strength of the heat seal, and this measure has been taken. It was shipped after additional heat sealing. It turned out that I had. Since there is a possibility that the warranty cannot be guaranteed, we will take measures to prevent the potential risk of harm to patients' health. We will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · May 24, 2021
Key facts
| Title | Some of the sterilization packs used for some products lack the strength of the heat seal, and this measure has been taken. It was shipped after additional heat sealing. It turned out that I had. Since there is a possibility that the warranty cannot be guaranteed, we will take measures to prevent the potential risk of harm to patients' health. We will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Endoscope soft grasping forceps Brand name: Grasping forceps S640026 |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | S640026 |
| Date | May 24, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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