AART recalls specific pectoral implants due to FDA approval deficiencies. Affected models include 500-106-5 to 500-403-6 with certain lot numbers. Consumers should check UDI-DI codes and contact the manufacturer.
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
AART is recalling specific pectoral implants that were distributed without proper FDA premarket approvals. This could pose risks if the implants are used in medical procedures. Affected products have unique model numbers and lot numbers listed in the recall notice.
The implants were distributed without the required FDA premarket approvals or clearances. This means they may not meet safety standards for medical use, potentially leading to complications during procedures.
Patients who received the recalled pectoral implants during medical procedures are most at risk. The recall affects specific models and lot numbers produced by DSAART LLC.
Check the UDI-DI code on the implant (e.g., B4905001065) and model numbers like 500-106-5 to 500-403-6. Affected products have specific lot numbers listed in the recall notice.
Identify the UDI-DI code and model numbers on the implant to confirm if it is affected.
The implants were distributed without the required FDA premarket approvals or clearances, which could affect safety during medical procedures.
Models 500-106-5 to 500-403-6 with specific lot numbers listed in the recall notice.
Check the UDI-DI code on the implant (e.g., B4905001065) and model numbers against the list provided in the recall notice.
We’ve drafted a message you can send AART to request your refund or repair — edit it as you like.
Subject: Recall Z-0948-2026 — AART AART Hello, I own a AART that is covered by recall Z-0948-2026 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.
