Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37599 |
| Brand Name: | Olympus - Ligating device, single-use (Japan) |
| Model: | SINGLE USE LIGATING DEVICE POLYLOOP (HX-400U-30) |
| Affected: | Multiple Lot numbers |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Olympus Medical Systems Corporation |
| Issue: | The manufacturer previously communicated a Product Correction (Medsafe Ref #36740) related to additional clarifications in the Instructions for Use (IFU) for proper release of the Single Use Ligating Device (HX-400U-30). Alternatively, customers may have received a Notification of IFU Change with recently purchased products. The action was taken based on complaints from customers indicating that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally anchored in place around patient anatomy. The manufacturer is introducing a design change to address complaints that the ligation loop was unable to release or detach as expected during use, with operation pipe breakage being one of the contributing factors to these complaints. The manufacturer revised the method used to secure the guide pipe. As a result, even if the sheath near the handle is not fully straightened, the operation pipe can be prevented from bending. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/9/2026 |
