FDA Medical devices recall · December 24, 2025

AART Gluteal Implant Product Name: Gluteal Implant Model recall

Read the official FDA notice ↗

Product

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

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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

Distribution

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

States: Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Illinois Kentucky Massachusetts Maryland Michigan Minnesota Mississippi Nebraska New Jersey New York Ohio Oklahoma Pennsylvania Puerto Rico Texas Utah Virginia Washington Wisconsin

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-0945-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.