International safety notice
After a sampling inspection, we discovered a slight crack in the casing of this product that had been stored. Although the cracks are difficult to spot, we cannot deny the possibility that the cracks will get bigger in the future, so we are implementing a voluntary recall. I decided to do so.
Japan / PMDA Recalls · JPN · Nov 8, 2021
Key facts
| Title | After a sampling inspection, we discovered a slight crack in the casing of this product that had been stored. Although the cracks are difficult to spot, we cannot deny the possibility that the cracks will get bigger in the future, so we are implementing a voluntary recall. I decided to do so. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: In-the-ear hearing aid Sales name: Medical listening plug |
| Manufacturer | Neuroceuticals Co., Ltd. |
| Models | 18L1L2UX, 18L1L1GQ, 18L1L2EJ, 18L1L32N, 18L1L4VH, 18L1L2XR, 18L1L2DD, 18L1L2EK, 18L1L2EE, 18L1L220, 18L1L48N, 18L1L2ZM and 946 more |
| Date | Nov 8, 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