Cytrellis Biosystems, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1648-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 7, 2023

Date Posted: June 7, 2023

Recall Number: Z-1648-2023

Event ID: 92187

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.

Status: Completed

Product Quantity: 89 units

Code Information:

UDI-DI: B933ELCON010 All serial numbers

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated