International safety notice
Users of this product have reported that the lock release button for releasing the movable aperture frame was damaged during surgical use. I have been contacted. The design life of the product may not reach its useful life. We are voluntarily recalling the product as there is a risk of the product being contaminated.
Japan / PMDA Recalls · JPN · Mar 22, 2024
Key facts
| Title | Users of this product have reported that the lock release button for releasing the movable aperture frame was damaged during surgical use. I have been contacted. The design life of the product may not reach its useful life. We are voluntarily recalling the product as there is a risk of the product being contaminated. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Hole opener Commercial name: Mouth opener with oral and throat mirror, Sato type, curved type |
| Manufacturer | Nagashima Medical Instruments Co., Ltd. |
| Models | V01SA, V07SA, M05aSA, V0901SA, M06SA, V09SA, M02aSA, M02SA |
| Date | Mar 22, 2024 |
| 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