Cytrellis ellacor System with Micro-Coring Technology-Dermal… — Class II medical device recall Z-1648-2023
Completed recall by Cytrellis Biosystems, Inc., reported 2023-06-07, distributed nationwide. Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolo
| Recall number | Z-1648-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytrellis Biosystems, Inc., Woburn, MA, United States |
| Recall initiated | 2023-04-07 |
| Classified | 2023-05-26 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 89 units |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1648-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.