FDA-Device2025-12-24Class IIPROCESSING DEFECT
AART Pectoral Implants recalled for unapproved manufacturing and FDA clearance violations
What this means
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.
- If you received an AART Pectoral Implant, contact your healthcare provider or surgeon immediately.
- Do not use or implant any AART Pectoral Implants from the affected lot numbers.
- Check the model and lot number on your device against the recall list.
The agency's original wording
Hazard
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Intended for
Adults
Illnesses reported
None reported
Sold states
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 count
41 implants
Manufactured in
2950 Arrowhead Dr, Carson City, NV, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0948-2026Want us to check the next one for you?
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