Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 22722 |
| Brand Name: | Cook Stonebreaker Pneumatic Lithotripter |
| Model: | |
| 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: | Cook Incorporated |
| Brand Name: | Stonebreaker CO2 Cartridge |
| Model: | |
| 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: | Cook Incorporated |
| Brand Name: | Stonebreaker Single Use Probe |
| Model: | |
| 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: | Cook Incorporated |
| Issue: | The manufacturer has identified that the interior of the product may not be sterilised to the appropriate sterility assurance level when following the reprocessing instructions provided in the Instructions for Use (IFU). Potential adverse events that may occur include urinary tract infection (UTI), pyelonephritis, and urosepsis. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 15/3/2018 |
