Reported Dec 24, 2025 · Ongoing
Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style…
Dsaart LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DSAART LLC · 2950 Arrowhead Dr · Carson City, NV · 89706-0488
Is this the product you have?
- Brand NameAART
- Pectoral Implant Product NamePectoral
- Implant Model/Catalog Number500-106-5 Pectoral
- Implant style 1 size 6 left UDI-DI codeB4905001065 500-106-6 Pectoral Implant
- style 1 size 6 right UDI-DI codeB4905001066 500-200-5 Pectoral
- Implant style 2 size 0 left UDI-DI code
B4950020205500-200-6500-201-5500-201-6500-202-5500-202-6500-403-5500-403-6
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Product as published 500-106-6Lot Number: 24-03-002 Model/ UDI-DI code: B4905001066 500-200-5Lot Number: 24-03-003 Model/ UDI-DI code: B4905002005 500-200-6Lot Numbers: 24-12-004 25-02-002 Model/ UDI-DI code: B4905002006 500-201-5Lot Numbers: 24-12-005 25-02-003 Model/ UDI-DI code: B4905002015 500-201-6Lot Numbers: 24-11-015 25-02-004 25-05-002 Model/ UDI-DI code: B4905002016 500-202-5Lot Numbers: 24-12-017 25-02-005 Model/ UDI-DI code: B4905002025 500-202-6Lot Numbers: 24-12-018 25-03-018 Model/ UDI-DI code: B4905002026 500-403-5Lot Numbers: 24-09-015 25-03-019 Model/ UDI-DI code: B4905004035 500-403-6Lot Number: 25-04-020 Model/ UDI-DI code: B4905004036 — Lot Number: 25-04-021 - Amount recalled
- 41 implants
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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