Class II — Bellus Medical
| Recalling firm | Bellus Medical, LLC |
|---|---|
| Registered facility | BELLUS MEDICAL, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Cosmetic Kit was packaged with a mislabel medical product. |
| 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. |
| Quantity | 6007 |
| Distribution | US Nationwide distribution. |
| Initiated | 2019-01-18 |
| Classified | 2019-12-09 |
| Terminated | 2021-03-05 |
| Recall number | Z-0660-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Bellus Medical (Z-0660-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84154/
Alerts for Bellus Medical, LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.