Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36883 |
| Brand Name: | Endo Therapy Disposable Sterile - Single Use Distal Cover |
| Model: | Olympus Single Use Distal Cover - Model MAJ-2315 |
| Affected: | Multiple affected 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 conducted an investigation into the Single Use Distal Covers after receiving complaints of the distal cover unexpectedly detaching from the duodenoscope during use. In the past 12 months, the manufacturer has received complaints pertaining to the MAJ-2315 distal cover falling off within or outside patients. This included events considered to be Serious Injury, which involved foreign body retrieval and/or additional treatment. To address this issue, the manufacturer has developed a newly designed version of the Distal Cover (MAJ-2315), which contains a new attachment tool to help mitigate the risk of incorrect attachment of the distal cover to the scope. All older versions of this product should be returned and replaced with the newly designed version. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 11/6/2026 |
