Olympus - Ligating Device, Single-use (japan)
Olympus Medical Systems Corporation is recalling single-use ligating devices distributed to hospitals, pharmacies, and laboratories in New Zealand. The recall is due to instructions for use that need to be updated. This is classified as a Class I recall, the most serious category.
- Recalling firm
- Olympus (NZ) Ltd
- Product
- Olympus - Ligating device, single-use (Japan). [Device]. 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
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-04-21
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/1e8c7ad2-e35f-4aca-be48-04c56af36cb4