International safety notice
After conducting an investigation by the manufacturing facility and conducting a leakage test on the individual packaging, it was found that the serial number and sterilization date were engraved. A leak has been detected. Due to this concern, we have decided to voluntarily recall the affected products.
Japan / PMDA Recalls · JPN · Dec 21, 2022
Key facts
| Title | After conducting an investigation by the manufacturing facility and conducting a leakage test on the individual packaging, it was found that the serial number and sterilization date were engraved. A leak has been detected. Due to this concern, we have decided to voluntarily recall the affected products. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: natural rubber surgical gloves Brand name: Okamoto surgical gloves powder free |
| Manufacturer | Okamoto Co., Ltd. |
| Models | 011022S, 102241S, 009091S, 005281S, 008221S, 103181S, 008081S, 005071S, 902211S, 012192S, 102232S, 007121S and 123 more |
| Date | Dec 21, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models 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