ellacor System with Micro-Coring Technology-Indicated for use by… — Class II medical device recall Z-2393-2023
Ongoing recall by Cytrellis Biosystems, Inc., reported 2023-08-16, distributed nationwide. Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the
| Recall number | Z-2393-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cytrellis Biosystems, Inc., Woburn, MA, United States |
| Recall initiated | 2023-06-23 |
| Classified | 2023-08-10 |
| Reported by FDA | 2023-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 127 systems |
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
Reason for recall
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
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-2393-2023. 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.