Z-0948-2026Class II

Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral...

Name: Z-0948-2026 Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral...
Creator: Dsaart Llc
Published: 2025-09-26
License: https://open.fda.gov/license/

Dsaart, LLC / initiated 2025-09-26 / Open, Classified / root cause: manufacturing process

FDA source

DSAART LLC began a recall of Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065... on 2025-09-26. FDA classified it as Class II and gives the reason as "Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0948-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-26
Posted: 2025-12-18
Recalling firm: Dsaart, LLC
Product: Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code: B4905001065 500-106-6 Pectoral Implant style 1 size 6 right UDI-DI code: B4905001066 500-200-5 Pectoral Implant style 2 size 0 left UDI-DI code: B4950020205 500-200-6 500-201-5 500-201-6 500-202-5 500-202-6 500-403-5 500-403-6
Product code: MIC Implant, Muscle, Pectoralis
Reason for recall: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Root cause tag: manufacturing process
FDA root cause: No Marketing Application
Action: On 09/26/2025, the firm emailed a notice to an affected customer informing them that due to identified testing issues, the firm was requesting return of gluteal implants. On 11/17/2025, the firm send an "URGENT Medical Device removal of AART Silicone Implants" Letter to customer informing them that Alpha Aesthetics is voluntarily removing products as they conduct an analysis to determine the regulatory status of the devices. Customers are instructed to: 1. Either return the affected products that have not been implanted to Alpha Aesthetics at the company's expense, or discard affected products. 2. Acknowledge their actions via the enclosed "Medical Device Return Response" letter/form. For questions or further assistance with this removal, contact ** or email **.
Quantity in commerce: 41 implants
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
Product codes and lots: Pectoral Implant Model/Catalog Number: 500-106-5 UDI-DI code: B4905001065 Lot Number: 24-03-002 Model/Catalog Number: 500-106-6 UDI-DI code: B4905001066 Lot Number: 24-03-003 Model/Catalog Number: 500-200-5 UDI-DI code: B4905002005 Lot Numbers: 24-12-004 25-02-002 Model/Catalog Number: 500-200-6 UDI-DI code: B4905002006 Lot Numbers: 24-12-005 25-02-003 Model/Catalog Number: 500-201-5 UDI-DI code: B4905002015 Lot Numbers: 24-11-015 25-02-004 25-05-002 Model/Catalog Number: 500-201-6 UDI-DI code: B4905002016 Lot Numbers: 24-12-017 25-02-005 Model/Catalog Number: 500-202-5 UDI-DI code: B4905002025 Lot Numbers: 24-12-018 25-03-018 Model/Catalog Number: 500-202-6 UDI-DI code: B4905002026 Lot Numbers: 24-09-015 25-03-019 Model/Catalog Number: 500-403-5 UDI-DI code: B4905004035 Lot Number: 25-04-020 Model/Catalog Number: 500-403-6 UDI-DI code: B4905004036 Lot Number: 25-04-021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0948-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0944-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0945-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0946-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0947-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0948-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18
Z-0949-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-18

Product code MIC

K021337Class IIAart Pectoralis ImplantAesthetic and Reconstructive Technologies, Inc. / cleared 2002-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)