DSAART LLC recalls Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style…

Recall date

September 26, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0948-2026

FDA classification

Class II

Brand / firm

DSAART LLC

Sold / distributed

U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI O.U.S.: N/A

Why it was recalled

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6