Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36655 |
| Brand Name: | Hand Files |
| Model: | Endodontic Hand Files (K-Flex, Triple-Flex, K-Files, Hedstrom) |
| Affected: | Multiple lot number |
| Software version: | |
| Recalling Organisation: | Law and Accounting Professional Trustees Limited 336, Jackson Street Petone |
| Contact Information: | 04 566 2853 |
| Manufacturer: | Kerr Italia Srl |
| Brand Name: | Reamers |
| Model: | Endodontic Hand Files ( Reamers) |
| Affected: | Multiple lot numbers |
| Software version: | |
| Recalling Organisation: | Law and Accounting Professional Trustees Limited 336, Jackson Street Petone |
| Contact Information: | 04 566 2853 |
| Manufacturer: | Kerr Italia Srl |
| Issue: | It has recently come to the manufacturer attention that the IFU has an error in the cleaning section step # 1 for the ultrasonic cycle time. The IFU incorrectly stated: Clean the hand pluggers in an ultrasonic device for five (5) minutes using a neutral-pH enzymatic ultrasonic detergent (Enzol Enzymatic Detergent, or equivalent) is recommended. However, the IFU should state: Clean the hand files in an ultrasonic device for ten (10) minutes using a neutral-pH enzymatic ultrasonic detergent (Enzol Enzymatic Detergent, or equivalent) is recommended. To this date, no adverse events have been reported. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 16/3/2026 |
