Olympus - Ligating Device, Single-use (japan)

Recalling firm

Olympus (NZ) Ltd

Product

Olympus - Ligating device, single-use (Japan). [Device]. Model: SINGLE USE LIGATING DEVICE POLYLOOP (HX-400U-30). Affected: Multiple Lot numbers

Reason

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...

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-09-21

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/4e943af4-03d7-4cb4-88c5-a7aee39524ec