Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 19111 |
| Brand Name: | Coloplast Restorelle |
| Model: | All models |
| Affected: | All lots |
| Software version: | |
| Recalling Organisation: | Culpan Distributors Ltd Unit 10 19 Hannigan Drive Mt Wellington Auckland |
| Contact Information: | 09 570 5752 |
| Manufacturer: | Coloplast A/S |
| Issue: | Following a TGA review, Coloplast Pty Ltd has made significant and substantive updates to the Instructions for Use (IFU) for the referenced products. Additional contraindications, warnings, and precautions have been added to present the most comprehensive and up to date information available. The key messages include the importance of: - appropriate patient selection; - surgeon experience; and - the need for fully informed patient consent. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 22/9/2015 |
