Class II — Cytrellis Biosystems, Inc.
| Recalling firm | Cytrellis Biosystems, Inc. |
|---|---|
| Registered facility | CYTRELLIS BIOSYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, and/or scarring. |
| Product | Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid and lower face. Model #: Gen 4 |
| Quantity | 89 units |
| Distribution | Nationwide |
| Initiated | 2023-04-07 |
| Classified | 2023-05-26 |
| Recall number | Z-1648-2023 |
| 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 — Cytrellis Biosystems, Inc. (Z-1648-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92187/
Alerts for Cytrellis Biosystems, Inc.
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.