Reported Dec 24, 2025 · Ongoing
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 -…
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
- Silicone Carving Implant Product NameSilicone
- Carving Implant Model/Catalog Numbers600-601 - Silicone Carving
- Implant Style 6 Size 1 UDI-DI codeB490600601 600-602 - Silicone Carving
- Implant Style 6 Size 2 UDI-DI codeB490600602 600-601-9 - Silicone Carving Implant Style 6
- Size 1 with Suture Tabs UDI-DI codeB4906006019 600-603-9 - Silicone Carving Implant Style 6
- Size 3 with Suture Tabs UDI-DI codeB4906006039 600-604-9 - Silicone Carving Implant Style 6
- Size 4 with Suture Tabs UDI-DI codeB4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2
- Smooth with Suture Tabs UDI-DI codeB49060060239 600-603 -Silicone Carving
- Implant Style 6 Size 3 UDI-DI codeB490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3
- Smooth with Suture Tabs UDI-DI codeB49060060339 600-604 - Silicone Carving
- Implant Style 6 Size 4 UDI-DI codeB490600604 600-605 - Silicone Carving
- Implant Style 6 Size 5 UDI-DI codeB490600605 600-801 - Silicone Carving
- Implant Style 8 Size 1 UDI-DI codeB490600801 600-803 - Silicone Carving
- Implant Style 8 Size 3 UDI-DI codeB490600803 600-804 - Silicone Carving
- Implant Style 8 Size 4 UDI-DI codeB490600804 Intended for Augmentation and reconstructive surgery. * Pending information
- Lot codes and dates
13 of 13 products
Products covered by this recall Model / number Product as published 600-602Lot Numbers: 25-01-003 25-01-010 25-01-022 25-02-012 25-03-001 25-04-004 25-05-006 25-05-015 25-06-011 25-06-017 Model/ UDI-DI code: B490600602 600-601-9Lot Numbers: 25-02-006 25-02-021 25-03-007 25-04-005 25-05-017 25-06-015 Model/ UDI-DI code: B4906006019 600-603-9Lot Number: 25-02-017 Model/ UDI-DI code: B4906006039 600-604-9Lot Number: 25-02-026 Model/ UDI-DI code: B4906006049 600-602-3-9Lot Number: 25-02-018 Model/ UDI-DI code: B49060060239 600-603Lot Number: 24-04-011 Model/ UDI-DI code: B490600603 600-603-3-9Lot Numbers: 24-11-005 25-01-011 25-02-007 25-02-020 Model/ UDI-DI code: B49060060339 600-604Lot Number: 24-01-013 Model/ UDI-DI code: B490600604 600-605Lot Numbers: 24-10-013 25-01-012 25-02-024 25-04-012 Model/ UDI-DI code: B490600605 600-801Lot Numbers: 24-05-003 25-01-013 25-06-012 Model/ UDI-DI code: B490600801 600-803Lot Numbers: 24-11-017 25-01-004 25-01-014 25-01-023 25-07-009 Model/ UDI-DI code: B490600803 600-804Lot Numbers: 24-09-016 25-01-015 Model/ UDI-DI code: B490600804 — Lot Number: 23-10-005 - Amount recalled
- 369 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Dsaart LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.