Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 32239 |
| Brand Name: | Soltive Fibres |
| Model: | TFL-FBX150S SOLTIVE LASER FIBRE 150 MICR- 200 MICR - 365 MICR, 550 MICR - 940 MICR, TFL-FBX150BS SOLTIVE LF 150M BALL TIP - 200M BALL TIP |
| Affected: | |
| 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 conducted an internal review of the SOLTIVE Single-use Fibers and identified inconsistencies in the IFU. The IFU currently instructs the user that the SOLTIVE Single-use Laser Fiber is cleaved first and then stripped, leaving 20 mm of exposed fiber. This presents the potential for the fiber to break during use. The potential harms related to a broken fiber include burns, procedure delays, prolonged surgery, and foreign body in patient. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 5/12/2023 |
