Stradis Healthcare recalls breast augmentation trays with item #570-0611 due to potential sterility breaches from incomplete bag sealing. Affected units sold through Henry Schein.
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
Stradis Healthcare is recalling breast augmentation trays (item #570-0611) because manufacturing issues might cause the outer bag to be incompletely sealed. This could breach the sterility of the surgical kit, risking infection during procedures.
The trays may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, breaking the sterility of the surgical kit and increasing infection risk during procedures.
Surgical professionals using the specific breast augmentation tray model. Patients undergoing procedures with this kit face the highest risk of infection.
Check for item number 570-0611 on the tray. Look for UDI/DI codes H65857006111 (case) or M75257006110 (kit), and serial numbers starting with 22257490683.
Verify the item number, UDI/DI codes, and serial numbers to confirm if your tray is affected.
The recall addresses a potential sterility breach risk, but the actual danger level is low as the hazard is not severe in normal use.
Check for item number 570-0611, UDI/DI codes H65857006111 (case) or M75257006110 (kit), and serial numbers starting with 22257490683.
The recall does not specify a remedy, so you should check product details to confirm if affected and contact Stradis Healthcare for further instructions.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0502-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0502-2023 from Stradis Healthcare. 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.
