Stradis Healthcare recalls oral surgery trays with incomplete bag sealing that could breach sterility. Affected units have specific serial numbers and UDI codes. Consumers should check their items and contact the company for details.
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 oral surgery trays that may have incomplete bag sealing, risking sterility breaches during medical procedures. This could lead to infections if the trays are used without proper sterility.
The trays may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, breaking the sterility required for surgical procedures and increasing infection risks.
Healthcare professionals using the oral surgery trays for procedures are most at risk. Patients receiving surgery using these trays could face infection risks if sterility is compromised.
Check for the serial number 22229491074 or UDI code M7524111UTI0 on the tray. The product is sold as an oral surgery tray with item number 41111UTI.
Look for the serial number 22229491074 or UDI code M7524111UTI0 on the tray.
The recall affects healthcare professionals using the trays. Patients are at risk only if surgery uses these trays without proper sterility checks.
Check for the serial number 22229491074 or UDI code M7524111UTI0 on the tray.
The recall 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-0494-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0494-2023 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.