International safety notice
Regarding the products subject to recall, the sterilization process was re-verified and was judged to have failed. We have come to the conclusion that the product that underwent the process has not been shipped. Products shipped after this date will be voluntarily recalled to prevent the risk of infection to patients.
Japan / PMDA Recalls · JPN · Jul 13, 2023
Key facts
| Title | Regarding the products subject to recall, the sterilization process was re-verified and was judged to have failed. We have come to the conclusion that the product that underwent the process has not been shipped. Products shipped after this date will be voluntarily recalled to prevent the risk of infection to patients. |
|---|---|
| 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 | 500454, 500468, 500465, 500457, 0915612-06, 500456 |
| Date | Jul 13, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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