Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 37520 |
| Brand Name: | Soltive Fibres |
| Model: | Olympus SOLTIVE SuperPulsed laser fibre |
| Affected: | Model: TFL-FBX150S, TFL-FBX150BS, TFL-FBX200S, TFL-FBX200BS, TFL-FBX365S, TFL-FBX550S, TFL-FBX940S |
| Software version: | |
| Recalling Organisation: | Olympus (NZ) Ltd 15D Paul Matthews Road Albany Auckland |
| Contact Information: | 0508 659 6787 |
| Manufacturer: | Gyrus ACMI Inc |
| Issue: | 29/9/26: Update - Olympus has determined that seven lots previously included in the corrective action were incorrectly identified and are not affected. These lots do not need to be returned. In 2025, the manufacturer identified an increase in complaints involving thermal events associated with SOLTIVE laser fibre devices. These events can occur when a break in the fibre core causes laser energy to disperse, potentially leading to accidental laser exposure, thermal damage, or ignition of nearby materials. In some cases, the strain relief component ignited and did not immediately self-extinguish. In May 2025 (Medsafe Ref #35238), the manufacturer notified customers of 175 reported malfunctions and two serious injuries worldwide, reinforced existing IFU safety guidance, and provided additional instructions for identifying damaged fibres. Since then, SOLTIVE laser fibre products have included a Quick Reference Guide to help users detect broken fibres and prevent thermal events. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/9/2026 |
