Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 29522 |
| Brand Name: | Zeltiq Coolsculpt System and Accessories |
| Model: | CoolCore Applicator BRZ-AP1-063-000, CoolCurve Applicator BRZ-AP1-062-000, CoolCurve+ Applicator BRZ-AP1-064-000,CoolMax Applicator BRZ-AP1-080-000, CoolFitApplicatorBRZ-AP1-066-000 |
| Affected: | |
| Software version: | |
| Recalling Organisation: | Allergan New Zealand Ltd Cnr Manu Tapu Drive & Joseph Hammond Place Auckland 2022 |
| Contact Information: | |
| Manufacturer: | Zeltiq Aesthetics Inc |
| Issue: | The manufacturer is recalling the following CoolSculpting-brandedparallel plate applicators (CoolCore, CoolCurve, CoolCurve+, CoolMax, and CoolFit) due to the observance of a slightly increased rate of Paradoxical Hyperplasia (PH) during a recent analysis of data from the 2019-2021 time frame. |
| Recall action type: | Recall |
| Recall action: | Product to be returned to supplier |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/6/2022 |
