International safety notice
For the products subject to recall, we were unable to obtain sufficient proof in the verification of the resterilization method. We have come to the conclusion that this is a product whose safety cannot be guaranteed. We will carry out a voluntary recall to prevent the risk of contamination.
Japan / PMDA Recalls · JPN · Dec 21, 2023
Key facts
| Title | For the products subject to recall, we were unable to obtain sufficient proof in the verification of the resterilization method. We have come to the conclusion that this is a product whose safety cannot be guaranteed. We will carry out a voluntary recall to prevent the risk of contamination. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Endoscopic soft biopsy forceps, (2) Endoscopic soft grasping forceps, (3) Reusable endoscopic non-active treatment instruments, (4) Hook, (5) Scissors, (6) Surgical rongeurs, (7) Surgical rongeurs Brand name: (1) Flexible biopsy forceps (2) Flexible grasping forceps (3) KARL STORZ working insert (4) Uvula retractor (5) KARL STORZ optical scissors (6) Antrum punch (7) Sphenoid bone punch |
| Manufacturer | KARL STORZ Endoscopy Japan Co., Ltd. |
| Models | 723014, 26161UH, 648500, 615000, 723400, 11540OS, 648523, 11003MB, 615025 |
| Date | Dec 21, 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