DSAART LLC: Device Recall
Recall #Z-0948-2026 · 09/26/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0948-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DSAART LLC
- Status
- Ongoing
- Date Initiated
- 09/26/2025
- Location
- Carson City, NV, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 implants
Reason for Recall
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Product Description
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
Distribution Pattern
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
Other Recalls by DSAART LLC
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
- Class II: Risk 09/26/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.