International safety notice
We have discovered that unintended fibers may appear on the surface of some of these products. Therefore, we decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Aug 2, 2021
Key facts
| Title | We have discovered that unintended fibers may appear on the surface of some of these products. Therefore, we decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: (1)(2) Single-use endoscopic non-active treatment device for natural opening Brand name: (1) PENTAX Medical endoscopic biopsy forceps VDK-FB (2)PENTAX Medical endoscope holding forceps VDK-FG |
| Manufacturer | HOYA Co., Ltd. |
| Models | FG20032201, FB20061908, FB19121808, FG20010201, VDK-FG-18-70-A4P, FB19122412, VDK-FB-18-105-O-P-B1P, VDK-FB-18-105-O-P-A1P, FB20032901 |
| Date | Aug 2, 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