International safety notice
We have recently received a report that the hose part of the APEX Wizard 510 mask has cracks. In this case, we requested the manufacturer to investigate the cause, and as a result, we found that there was a defect in some of the manufacturing processes for the products in question, and the product was long-lasting. It was discovered that the product could not maintain its durability when subjected to a certain amount of force during use, leading to a voluntary recall. We have decided.
Japan / PMDA Recalls · JPN · Nov 5, 2021
Key facts
| Title | We have recently received a report that the hose part of the APEX Wizard 510 mask has cracks. In this case, we requested the manufacturer to investigate the cause, and as a result, we found that there was a defect in some of the manufacturing processes for the products in question, and the product was long-lasting. It was discovered that the product could not maintain its durability when subjected to a certain amount of force during use, leading to a voluntary recall. We have decided. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: respirator mask Sales name: Wizard 510 Mask |
| Manufacturer | MAGnet Co., Ltd. |
| Models | 110210105, 110210512 |
| Date | Nov 5, 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