Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 18897 |
| Brand Name: | AMS SureFlex Reusable Fibers |
| Model: | Models: R-LLF150TG, R-LLF200TG, R-LLF273TG, R-LLF365, R-LLF550, R-LLF910, 8013046, 8013056 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | American Medical Systems Inc |
| Brand Name: | AMS SureFlex Resuable Stripper |
| Model: | 80-10001-003, 80-10002-003, 80-10003-003, 80-10005-003, 80-10011-003, 80-10008-003, 80-10001-001, 80-10001-002, 80-10002-001, 80-10002-002, 80-10003-001, 80-10003-002, 80-10005-001, 80-10005-002, 80-10008-001, 80-10008-002, |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | American Medical Systems Inc |
| Brand Name: | AMS SureFlex Fiber Cleavers |
| Model: | 0010-0760, 80-10007-001 |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Obex Medical Ltd Level 3, 109 Carlton Gore Road Newmarket Auckland 1023 |
| Contact Information: | 0800 656 539 |
| Manufacturer: | American Medical Systems Inc |
| Issue: | The manufacturer has determined that validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the SureFlex™ Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 21/7/2015 |
