Home / Recalls / Cytrellis Biosystems, Inc. / Z-1648-2023

Z-1648-2023 Class II

Recalled by Cytrellis Biosystems, Inc. — Woburn, MA

FDA device recall Z-1648-2023 was initiated by Cytrellis Biosystems, Inc. on Apr 7, 2023 and is designated Class II. 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. Affected quantity: 89 units.

Recall details

Product Type: Devices
Report Date: Jun 7, 2023
Initiation Date: Apr 7, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 89 units

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

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.

Distribution pattern

Nationwide

Code information

UDI-DI: B933ELCON010 All serial numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1648-2023
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.