# FDA recall Z-1648-2023

> **Cytrellis Biosystems, Inc.** · Class II · device recall initiated 2023-04-07.

## 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

## 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

Nationwide

## Key facts

- **Recall number:** Z-1648-2023
- **Recalling firm:** Cytrellis Biosystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2023-04-07
- **Report date:** 2023-06-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woburn, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1648-2023

## Citation

> AI Analytics. FDA recall Z-1648-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1648-2023. Source: US FDA. Licensed CC0.

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