Cytrellis Biosystems, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Cytrellis Biosystems, Inc.
Lot Codes / Batch Numbers
UDI-DI: B933ELCON010 All serial numbers
Products Sold
UDI-DI: B933ELCON010 All serial numbers
Cytrellis Biosystems, Inc. is recalling Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for due to Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Cytrellis issued Medical Device Update / Product Notification Letter via email on 4/7/23. Letter states reason for recall, heath risk and action to take: Important information is included in the new Quick Reference Guide, with emphasis on the following points: "DO NOT impede tubing on handpiece. "DO NOT apply forceful downward pressure. "DO NOT TOUCH needle cartridge tubing while treating patient. Your PDM will be reaching out soon to set up time with you and your staff to review the Quick Reference Guide, and we would also like to invite you to join our medical team in one of two live informative webinars to review best practices and answer any questions that you might have. These webinars will be hosted by our Medical Director, Dr. Ashish Bhatia, along with the Cytrellis Medical Affairs team. Invitations to the webinars will be sent shortly. For additional information or inquiries, please email medicalinformation@cytrellis.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026