International safety notice
We received information from a medical institution that ``there were some products whose blades and handles were insufficiently secured.'' As a result of the investigation, we found that due to changes over time, the strength of the blade fixed to the handle decreases, and in some cases the blade detaches from the handle. It turns out that there is a risk of it falling off. We cannot deny the possibility that similar defects will occur in products manufactured after May 2022, so we will issue 5 affected products. We have decided to recall 61 lots.
Japan / PMDA Recalls · JPN · Aug 28, 2023
Key facts
| Title | We received information from a medical institution that ``there were some products whose blades and handles were insufficiently secured.'' As a result of the investigation, we found that due to changes over time, the strength of the blade fixed to the handle decreases, and in some cases the blade detaches from the handle. It turns out that there is a risk of it falling off. We cannot deny the possibility that similar defects will occur in products manufactured after May 2022, so we will issue 5 affected products. We have decided to recall 61 lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use ophthalmic knife Sales name: Microfeather plastic handle |
| Manufacturer | Feather Safety Razor Co., Ltd. |
| Models | 22100613, 22111187, 23040591, 22070791, 22070833, 22120409, 23030184, 23030569, P-730, 22120361, 22080792, 23010788 and 54 more |
| Date | Aug 28, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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