Stradis Healthcare recalls oral surgery trays with incomplete bag seals that could breach sterility. Affected items have specific serial numbers and were sold in the U.S. Learn how to check and what to do.
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 seals, risking sterility breaches during medical procedures. This could lead to infections if the trays are used without proper sterilization.
The outer bag may not seal properly during manufacturing, potentially allowing contamination. If the tray is used without proper sterilization, it could introduce infections during medical procedures.
Healthcare professionals and dental clinics using the recalled oral surgery trays. Those handling the trays without verifying sterility are at risk of infection.
Check for serial numbers starting with 22234489435 on the packaging. The product is identified by the UDI/DI code M75240788SMS1 (case) or M75240788SMS0 (kit).
Look for serial numbers starting with 22234489435 on the packaging.
The outer bag may not seal properly, risking contamination and infection if the tray is used without proper sterilization.
Check for serial numbers starting with 22234489435 on the packaging.
The recall does not provide a remedy; affected users should stop using the product and contact the manufacturer.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0491-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0491-2023 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.
