International safety notice
In the three types of bottles (EG-111A, EG-120A, EG-121A) that are the components of the product, the amount of colorant mixed was inappropriate and the bottle was damaged. We are implementing a voluntary recall as it has been confirmed that the welding between the parts is insufficient.
Japan / PMDA Recalls · JPN · Apr 8, 2024
Key facts
| Title | In the three types of bottles (EG-111A, EG-120A, EG-121A) that are the components of the product, the amount of colorant mixed was inappropriate and the bottle was damaged. We are implementing a voluntary recall as it has been confirmed that the welding between the parts is insufficient. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: (1) Dental multipurpose ultrasonic treatment device (2) Electric tooth surface cleaning device Sales name: (1) Airflow Prophylaxis Master (2) Air flow one |
| Manufacturer | ICST Co., Ltd. |
| Models | KU25676, KU22400, KU23492, LD05142, LD04865, KU24084, KU22374, LD05628, KU26619, KU23335, KU23903, KU22371 and 920 more |
| Date | Apr 8, 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