Recalled AART Silicone Carving Implants (models 600-601 to 600-804) due to FDA approval issues. Check UDI-DI codes and lot numbers for affected items.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
AART is recalling silicone carving implants that were distributed without proper FDA premarket approvals. This could lead to safety risks during surgical procedures if the implants do not meet required specifications.
The implants were distributed without obtaining necessary FDA premarket approvals or clearances, meaning they may not meet established safety standards. This could result in improper surgical outcomes or complications during procedures.
Patients who received these implants for augmentation or reconstructive surgery are likely affected. Surgeons and medical facilities using the recalled products are at risk of complications.
Check for UDI-DI codes starting with B490600601 to B490600804 and specific lot numbers listed in the recall notice. The products are intended for surgical use only.
Review the UDI-DI code and lot numbers on the implant to confirm if it matches the recalled items listed in the notice.
The products were distributed without obtaining the required FDA premarket approvals or clearances, which may mean they do not meet established safety standards.
The recall notice does not specify a remedy, so contact the manufacturer directly for guidance.
Yes, the recall lists specific lot numbers for each model, such as 25-01-003 for model 600-601.
We’ve drafted a message you can send AART to request your refund or repair — edit it as you like.
Subject: Recall Z-0944-2026 — AART AART Hello, I own a AART that is covered by recall Z-0944-2026 from AART. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
