Stradis Healthcare recalls oral surgery trays with potential sterility breaches from incomplete bag seals. Affected units have specific serial numbers and item numbers. Consumers should check their trays for the listed identifiers.
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 unsterile kits during medical procedures. This could lead to infections or complications if the tray is used without proper sterility.
The trays may have bags that aren't sealed properly during manufacturing, which could allow contamination. If the kit isn't sterile, it might cause infections or complications during surgery.
Healthcare professionals and dental clinics using Stradis Healthcare oral surgery trays with the specific serial numbers listed. Patients using these trays during procedures are at minimal risk if the trays are properly sterilized.
Check for the item number 40551TMS, serial numbers starting with 22230489112, or the UDI/DI codes M75240551TMS1 (case) and M75240551TMS0 (kit).
Look for the item number 40551TMS, serial numbers starting with 22230489112, or the UDI/DI codes M75240551TMS1 (case) and M75240551TMS0 (kit).
The trays may have bags that aren't sealed properly during manufacturing, which could allow contamination and compromise sterility.
Check your trays for the specific item number, serial numbers, or UDI/DI codes listed in the recall notice. If you have the affected items, you should check with Stradis Healthcare for further instructions.
The recall addresses potential sterility issues, not direct injury risks. Using the trays without proper sterility could lead to infections, but the hazard is not described as causing serious injury in normal use.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0487-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0487-2023 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.
