Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0944-2026 — 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 S

U.S. FDA — Device Enforcement · United States · 2025-09-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0944-2026
Date of alert: 2025-09-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DSAART LLC
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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