Stradis Healthcare recalls oral surgery trays with incomplete bag seals that could breach sterility during medical procedures. Affected units include specific model numbers and serial lots.
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 certain oral surgery trays because the outer packaging may not seal properly, risking contamination during medical procedures. This could lead to infections if the tray is used without proper sterility.
The trays' outer bags may not seal completely during manufacturing, potentially allowing contamination. If the sterile packaging is breached, the tray could become contaminated and cause infections during surgery.
Healthcare professionals using the recalled oral surgery trays for procedures are most at risk. Patients receiving surgery with these trays could face infection if sterility is compromised.
Check for the model number 40310SBI on the tray or the serial/lot numbers 22241489853. The product was sold with specific UDI/DI codes M75240310SBI1 and M75240310SBI0.
Look for the model number 40310SBI and serial/lot numbers 22241489853 on the tray.
The outer bag may not seal completely, risking contamination during medical procedures.
Check the model number and serial/lot numbers to see if it's affected; no specific action is required beyond checking.
The recall addresses potential contamination risk, not direct injury. Serious injury is not mentioned in the record.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0484-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0484-2023 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.
