Class II Recall

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

Summary

The FDA issued a Class II for Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog by DSAART LLC. Reason: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approval.

Details

Source

Device Recall

External ID

Z-0948-2026

Action Date

2025-12-24

Status

Ongoing

Product 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

Lot/Code Info: 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

Quantity Affected: 41 implants

Reason for Recall

Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

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

Type: Voluntary: Firm initiated

Recall Initiated: 2025-09-26

Company

DSAART LLC

Carson City, NV

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.

DSAART LLC has 6 FDA actions in our database, including 6 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DSAART LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does DSAART LLC have FDA actions?

DSAART LLC has 6 FDA actions in our database, including 6 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0948-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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