FDA Medical Device Recalls (openFDA)
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 number
- Z-1648-2023
- Recalling firm
- Cytrellis Biosystems, Inc.
- 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
- Status
- Completed
- Initiated
- 2023-04-07
- Posted
- 2023-05-26
- Terminated
- not on file
- 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.
- Root cause
- Use error
- Action
- 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
- Quantity
- 89 units
- Distribution
- Nationwide
- Lot, serial or model codes
- UDI-DI: B933ELCON010 All serial numbers
- 510(k) numbers
- ["K202517"]
- PMA numbers
- not on file
- Product code
- QAI
- Firm FEI
- 3020704367
- Firm city
- Woburn
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28