Stradis Healthcare recalls dental trays with potential sterility breaches. Affected units have specific serial numbers; contact for return or replacement.
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 dental trays that may have unsealed outer bags, risking contamination during surgery. This could lead to infections if used without proper sterility.
The outer bag may not seal properly during manufacturing, creating a breach in the sterility of the surgical kit. This could allow contaminants to enter the kit, increasing infection risk during procedures.
Dental professionals and clinics using Stradis Healthcare dental trays with the specific serial numbers listed. Those handling the trays during medical procedures are most at risk.
Check for the serial numbers: 22230491043, or the UDI/DI (case) M75241015NSI1 and UDI/DI (kit) M75241015NSI0 on the product packaging.
Look for the serial number 22230491043 or UDI/DI codes M75241015NSI1 (case) and M75241015NSI0 (kit) on the dental tray packaging.
The dental trays may have an outer bag that isn't sealed properly, which could lead to contamination during medical procedures.
Check for the serial number 22230491043 or UDI/DI codes M75241015NSI1 (case) and M75241015NSI0 (kit) on the product packaging.
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-0493-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0493-2023 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.
