FDA Device recall Z-0660-2020
SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used…
- FDA Device
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used… by Bellus Medical, citing cosmetic Kit was packaged with a mislabel medical product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0660-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-18 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bellus Medical |
| Distribution | US |
Product
SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dressing to protect against abrasion and friction during the microneedling procedure.
Reason
Cosmetic Kit was packaged with a mislabel medical product.
Identifiers
| code_info | Bellus Lot 16053 list on the SKINFUSE LIFT HG tube within the SKINFUSE Rescue Calming Complex Kit |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0660-2020%22
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