Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36740 |
| Brand Name: | Olympus - Ligating device, single-use (Japan) |
| Model: | SINGLE USE LIGATING DEVICE POLYLOOP - Model - HX-400U-30/ N5382130 |
| Affected: | Lots - 35V to 39V, 3XV, 3YV, 3ZV, 41V to 49V, 4XV, 4YV, 4ZV, 51V to 59V |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Olympus Medical Systems Corporation |
| Issue: | In a communication dated 4 November 2025 (Medsafe Ref# 36102), the manufacturer informed users of complaints that the ligation loop could fail to release as intended, becoming unintentionally anchored around patient anatomy. Globally, serious injuries have been reported, with no deaths. The manufacturer determined the issue was caused by inadvertent or intentional movement of the yellow tube joint away from the device handle during use, particularly when moved to prematurely tighten the loop, which can prevent proper loop release. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/4/2026 |
