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

AART Gluteal Implant Gluteal Implant recalled by DSAART

Dsaart is recalling AART Gluteal Implant Gluteal 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 codesGluteal Implant Model/Catalog Number: 501-101 UDI-DI code: B490501101 Lot Number: 24-01-030 Model/Catalog Number: 501-103 UDI-DI code: B490501103 Lot Numbers: 24-12-003 25-06-014 25-07-022 Model/Catalog Number: 501-105 UDI-DI code: B490501105 Lot Numbers: 24-07-012 24-09-013 Model/Catalog Number: 501-206 UDI-DI code: B490501206 Lot Number: 24-06-017 Model/Catalog Number: 501-301 UDI-DI code: B490501301 Lot Numbers: 23-10-020 25-01-021 Model/Catalog Number: 501-302 UDI-DI code: B490501302 Lot Numbers: 24-12-001 25-01-016 25-03-003 Model/Catalog Number: 501-303 UDI-DI code: B490501303 Lot Numbers: 24-10-004 24-11-001 25-01-017 25-02-011 25-03-003 25-04-009 Model/Catalog Number: 501-304 UDI-DI code: B490501304 Lot Numbers: 24-01-005 24-10-005 24-02-018 24-12-016 Model/Catalog Number: 501-305 UDI-DI code: B490501305 Lot Numbers: 24-09-009 25-01-001 25-03-004 25-04-010 Model/Catalog Number: 501-306 UDI-DI code: B490501306 Lot Numbers: 24-10-011 25-01-002 25-06-027 Model/Catalog Number: 501-307 UDI-DI code: B490501307 Lot Numbers: 24-09-010 24-12-002 25-04-007 Model/Catalog Number: 501-309 UDI-DI code: B490501309 Lot Number: 24-02-022 Model/Catalog Number: 501-310 UDI-DI code: B490501310 Lot Numbers: 24-10-010 25-02-009

Quantity recalled118 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-0945-2026
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 Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-101 UDI-DI code: B490501101 501-103 - Gluteal Implant style 1 size 3 UDI-DI code: B490501103 501-105 - Gluteal Implant style 1 size 5 UDI-DI code: B490501105 501-206 - Gluteal Implant style 2 size 6 UDI-DI code: B490501206 501-301 - Gluteal Implant style 3 size 1 UDI-DI code: B490501301 501-302 - Gluteal Implant style 3 size 2 UDI-DI code: B490501302 501-303 - Gluteal Implant style 3 size 3 UDI-DI code: B490501303 501-304 - Gluteal Implant style 3 size 4 UDI-DI code: B490501304 501-305 - Gluteal Implant style 3 size 5 UDI-DI code: B490501305 501-306 - Gluteal Implant style 3 size 6 UDI-DI code: B490501306 501-307 - Gluteal Implant style 3 size 7 UDI-DI code: B490501307 501-309 - Gluteal Implant style 3 size 9 UDI-DI code: B490501309 501-310 - Gluteal Implant style 3 size 10 UDI-DI code: B490501310

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?

Gluteal Implant Model/Catalog Number: 501-101 UDI-DI code: B490501101 Lot Number: 24-01-030 Model/Catalog Number: 501-103 UDI-DI code: B490501103 Lot Numbers: 24-12-003 25-06-014 25-07-022 Model/Catalog Number: 501-105 UDI-DI code: B490501105 Lot Numbers: 24-07-012 24-09-013 Model/Catalog Number: 501-206 UDI-DI code: B490501206 Lot Number: 24-06-017 Model/Catalog Number: 501-301 UDI-DI code: B490501301 Lot Numbers: 23-10-020 25-01-021 Model/Catalog Number: 501-302 UDI-DI code: B490501302 Lot Numbers: 24-12-001 25-01-016 25-03-003 Model/Catalog Number: 501-303 UDI-DI code: B490501303 Lot Numbers: 24-10-004 24-11-001 25-01-017 25-02-011 25-03-003 25-04-009 Model/Catalog Number: 501-304 UDI-DI code: B490501304 Lot Numbers: 24-01-005 24-10-005 24-02-018 24-12-016 Model/Catalog Number: 501-305 UDI-DI code: B490501305 Lot Numbers: 24-09-009 25-01-001 25-03-004 25-04-010 Model/Catalog Number: 501-306 UDI-DI code: B490501306 Lot Numbers: 24-10-011 25-01-002 25-06-027 Model/Catalog Number: 501-307 UDI-DI code: B490501307 Lot Numbers: 24-09-010 24-12-002 25-04-007 Model/Catalog Number: 501-309 UDI-DI code: B490501309 Lot Number: 24-02-022 Model/Catalog Number: 501-310 UDI-DI code: B490501310 Lot Numbers: 24-10-010 25-02-009

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 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

More recalls from Dsaart

All 6

Reported	Class	Recall	Company	Reason	Where
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 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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