Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs UDI-DI code: B49060060239 600-603 -Silicone Carving Implant Style 6 Size 3 UDI-DI code: B490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339 600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604 600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605 600-801 - Silicone Carving Implant Style 8 Size 1 UDI-DI code: B490600801 600-803 - Silicone Carving Implant Style 8 Size 3 UDI-DI code: B490600803 600-804 - Silicone Carving Implant Style 8 Size 4 UDI-DI code: B490600804 Intended for Augmentation and reconstructive surgery. * Pending information
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
AART Silicone Carving Implant Model/Catalog Number: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 Lot 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/Catalog Number: 600-602 UDI-DI code: B490600602 Lot Numbers: 25-02-006 25-02-021 25-03-007 25-04-005 25-05-017 25-06-015 Model/Catalog Number: 600-601-9 UDI-DI code: B4906006019 Lot Number: 25-02-017 Model/Catalog Number: 600-603-9 UDI-DI code: B4906006039 Lot Number: 25-02-026 Model/Catalog Number: 600-604-9 UDI-DI code: B4906006049 Lot Number: 25-02-018 Model/Catalog Number: 600-602-3-9 UDI-DI code: B49060060239 Lot Number: 24-04-011 Model/Catalog Number: 600-603 UDI-DI code: B490600603 Lot Numbers: 24-11-005 25-01-011 25-02-007 25-02-020 Model/Catalog Number: 600-603-3-9 UDI-DI code: B49060060339 Lot Number: 24-01-013 Model/Catalog Number: 600-604 UDI-DI code: B490600604 Lot Numbers: 24-10-013 25-01-012 25-02-024 25-04-012 Model/Catalog Number: 600-605 UDI-DI code: B490600605 Lot Numbers: 24-05-003 25-01-013 25-06-012 Model/Catalog Number: 600-801 UDI-DI code: B490600801 Lot Numbers: 24-11-017 25-01-004 25-01-014 25-01-023 25-07-009 Model/Catalog Number: 600-803 UDI-DI code: B490600803 Lot Numbers: 24-09-016 25-01-015 Model/Catalog Number: 600-804 UDI-DI code: B490600804 Lot Number: 23-10-005
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
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
Recall record
- Recalling firm
- DSAART LLC
- Product type
- Devices
- Recall number
- Z-0944-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Carson City, NV
- Recall initiated
- 2025-09-26
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0944-2026 · Source: openFDA enforcement.