Recall Weekly
Moderate riskFDA DeviceClass II

AART Pectoral Implants recalled for unapproved manufacturing and FDA clearance violations

DSAART LLC distributed AART Pectoral Implants that were manufactured differently than approved and were sold without required FDA clearance. The implants do not meet established safety and quality standards. Affected models were distributed across multiple U.S. states.

From the FDA notice · Read the official notice ↗

What to do

  1. If you received an AART Pectoral Implant, contact your healthcare provider or surgeon immediately.
  2. Do not use or implant any AART Pectoral Implants from the affected lot numbers.
  3. Check the model and lot number on your device against the recall list.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
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
Made for
Adults (18 years to 100 years)

This recall covers 6 products — see all of them.

Details

Units affected
41 implants
Illnesses reported
None reported
Manufactured in
2950 Arrowhead Dr, Carson City, NV, United States
Classification
Class II
Recall number
Z-0948-2026

In the FDA's words

Description
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 Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances. 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 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 Affected quantity: 41 implants
Hazard
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

6 products in this recall

AART silicone implants recalled for lacking FDA approval

DSAART is recalling six AART silicone implant products, covering about 594 implants in total. The implants were made outside the company's specifications and were distributed without the FDA premarket approval or clearance required for them. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Related topics

OtherMedical devicesARAZCACOCTDCFLGAILKYMAMDMIMNMSNENJNYOHOKPATXUTVAWAWIMore from FDA Device