Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36478 |
| Brand Name: | EBUS Needle 19G |
| Model: | NA-U403SX-4019 VIZISHOT 2 FLEX EBUS-TBNA NEEDLE |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Gyrus ACMI Inc |
| Issue: | The manufacturer received complaints for the ViziShot 2 FLEX (19G) devices in which the hypotube component ejected from the device or plastic components detached during use. Since the previous Recall notice in August 2025, internal investigations have identified additional contributing factors to hypotube component ejection including device heat-shrink material degradation and use errors. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/1/2026 |
