Z-1648-2023Class II

Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the...

Name: Z-1648-2023 Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the...
Creator: Cytrellis Biosystems, Inc.
Published: 2023-04-07
License: https://open.fda.gov/license/

Cytrellis Biosystems, Inc. / initiated 2023-04-07 / Completed

FDA source

Cytrellis Biosystems, Inc. began a recall of Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid... on 2023-04-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-1648-2023
Classification: Class II
Status: Completed
Initiated: 2023-04-07
Posted: 2023-05-26
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
Product code: QAI Powered Microneedle Device
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.
FDA 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 [email protected]
Quantity in commerce: 89 units
Distribution: Nationwide
Product codes and lots: UDI-DI: B933ELCON010 All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1648-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1648-2023	Class II	Completed	Voluntary: Firm initiated	2023-06-07	2023-05-26

Product code QAI

K202517Class IICytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc. / cleared 2021-07-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)