Stradis Healthcare recalls custom dental trays with potentially unsealed sterilization bags that could breach sterility. Affected units have specific serial numbers and item codes.
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 custom dental trays that may have unsealed sterilization bags. This could breach the sterility of the kit during medical procedures, risking infection for patients.
The trays may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, breaking the sterility of the kit and increasing infection risk during medical procedures.
Dental professionals using the recalled custom trays for medical procedures. Patients undergoing surgery or dental work with these kits face the highest risk of infection.
Check for the item number 41213ATCP on the tray packaging. Look for serial numbers starting with 22262491452 or UDI codes M75241213ATCP1 (case) and M75241213ATCP0 (kit).
Verify the item number, serial numbers, and UDI codes on the packaging to confirm if your tray is affected.
The trays may have outer bags that aren't sealed properly during manufacturing, which could breach sterility and increase infection risk during medical procedures.
Check for the item number 41213ATCP on the packaging and serial numbers starting with 22262491452 or UDI codes M75241213ATCP1 (case) and M75241213ATCP0 (kit).
The recall record does not specify a remedy, so contact Stradis Healthcare directly for guidance.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0496-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0496-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
