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

AART Chin Implant Chin Implant recalled by DSAART

Dsaart is recalling AART Chin Implant Chin 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 codesChin Implant Model/Catalog Number: 400-0101 UDI-DI code: B490400101 Lot Number: 25-01-018 Model/Catalog Number: 400-0103 UDI-DI code:B490400103 Lot Numbers: 23-11-018 25-01-019 Model/Catalog Number: 400-0104 UDI-DI code: B490400104 Lot Number: 24-01-016 Model/Catalog Number: 400-0201 UDI-DI code: B409400201 Lot Number: 24-05-012 Model/Catalog Number: 400-0202 UDI-DI code: B490400202 Lot Number: 25-01-020 Model/Catalog Number: 400-0301 UDI-DI code: B490400301 Lot Numbers: 23-09-024 24-03-036 Model/Catalog Number: 400-0302 UDI-DI code: B490400302 Lot Number: 24-03-037

Quantity recalled29 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-0946-2026
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 Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 400-0103 Chin Implant style 1 size 3 UDI-DI code: B490400103 400-0104 Chin Implant style 1 size 4 UDI-DI code: B490400104 400-0201 Chin Implant style 2 size 1 UDI-DI code: B490400201 400-0202 Chin Implant style 2 size 2 UDI-DI code: B490400202 400-0301 Chin Implant style 3 size 1 UDI-DI code: B49044301 400-0302 Chin Implant style 3 size 2 UDI-DI code: B490400302

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?

Chin Implant Model/Catalog Number: 400-0101 UDI-DI code: B490400101 Lot Number: 25-01-018 Model/Catalog Number: 400-0103 UDI-DI code:B490400103 Lot Numbers: 23-11-018 25-01-019 Model/Catalog Number: 400-0104 UDI-DI code: B490400104 Lot Number: 24-01-016 Model/Catalog Number: 400-0201 UDI-DI code: B409400201 Lot Number: 24-05-012 Model/Catalog Number: 400-0202 UDI-DI code: B490400202 Lot Number: 25-01-020 Model/Catalog Number: 400-0301 UDI-DI code: B490400301 Lot Numbers: 23-09-024 24-03-036 Model/Catalog Number: 400-0302 UDI-DI code: B490400302 Lot Number: 24-03-037

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 Malar Implant Malar 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 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 Silicone Carving Implant Silicone Carving Implant recalled	Dsaart	Other	27 states
24 Dec 2025Device	CLASS II	AART Malar Implant Malar Implant recalled by DSAART	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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