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 | Ongoing |
| Reason | Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring |
| Product | ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick skin types I-IV. Model #: Gen 4 |
| Quantity | 127 systems |
| Distribution | Nationwide |
| Initiated | 2023-06-23 |
| Classified | 2023-08-10 |
| Recall number | Z-2393-2023 |
| 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-2393-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/92689/
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