CLASS II ONGOING Device recall · Reported 24 Dec 2025 · FDA Enforcement Report

AART Malar Implant Malar Implant recalled by DSAART

Dsaart is recalling AART Malar Implant Malar Implant, distributed in 27 states. The recall was initiated on 26 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMalar Implant Model/Catalog Number: 401-202-5 UDI-DI code: B4904012025 Lot Number: 24-01-014 Model/Catalog Number: 401-202-6 UDI-DI code: B4904012026 Lot Number: 24-01-015

Quantity recalled2 implants

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0947-2026
FDA event ID: 97704
Recalling firm: Dsaart, Carson City, NV
Classification: Class II
Status: Ongoing
Recall initiated: 26 Sep 2025
FDA classified: 18 Dec 2025
Reported: 24 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

26 Sep 2025	Recall initiated by company
18 Dec 2025	Classified by FDA	+83 days
24 Dec 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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 as listed by the FDA

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

Where it was 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

Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Kentucky Massachusetts Maryland Michigan Minnesota Mississippi Nebraska New Jersey New York Ohio Oklahoma

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Malar Implant Model/Catalog Number: 401-202-5 UDI-DI code: B4904012025 Lot Number: 24-01-014 Model/Catalog Number: 401-202-6 UDI-DI code: B4904012026 Lot Number: 24-01-015

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 97704

This product is part of a recall event; the main page for the event is AART Calf Implant Calf Implant recalled by DSAART.

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025	CLASS II	AART Calf Implant Calf Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025	CLASS II	AART Silicone Carving Implant Silicone Carving Implant recalled	Dsaart	Other	27 states
24 Dec 2025	CLASS II	AART Chin Implant Chin Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025	CLASS II	AART Pectoral Implant Pectoral Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025	CLASS II	AART Gluteal Implant Gluteal Implant recalled by DSAART	Dsaart	Other	27 states

More recalls from Dsaart

All 6

Reported	Class	Recall	Company	Reason	Where
24 Dec 2025Device	CLASS II	AART Gluteal Implant Gluteal Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025Device	CLASS II	AART Pectoral Implant Pectoral Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025Device	CLASS II	AART Chin Implant Chin Implant recalled by DSAART	Dsaart	Other	27 states
24 Dec 2025Device	CLASS II	AART Silicone Carving Implant Silicone Carving Implant recalled	Dsaart	Other	27 states
24 Dec 2025Device	CLASS II	AART Calf Implant Calf Implant recalled by DSAART	Dsaart	Other	27 states

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