Recall Z-0947-2026— DSAART LLC

Name: FDA recall Z-0947-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-26

Class II · Ongoing

Class II FDA medical device recall by DSAART LLC, initiated 2025-09-26. It names one FDA 510(k) clearance: K021419. Product: Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026. Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances..

Recalling firm: DSAART LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-09-26
Firm location: Carson City, NV, United States

510(k) clearances named in this recall

1 on FDA's record

K021419 — AART MALAR IMPLANTAesthetic and Reconstructive Technologies, Inc.·cleared 2002-07-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.