Stradis Healthcare recalls ENT surgical kits with potential sterility breaches due to incomplete bag sealing. Affected items include specific model numbers and serials sold through Henry Schein. Consumers should check their kits for proper sealing.
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 ENT surgical kits that may have incomplete bag sealing, risking sterility breaches. This could lead to infections if the kits are used without proper sterility.
The outer bag may not seal completely during manufacturing, creating a breach in the sterility of the surgical kit. If the kit is used without proper sterility, it could lead to infections.
Healthcare professionals using ENT surgical kits with the specific model number 570-2718 and serial numbers 22242489582 or 22256491864 are most at risk. These kits were sold through Henry Schein.
Check for the model number 570-2718 and serial numbers 22242489582 or 22256491864 on the kit's packaging. These kits were sold through Henry Schein.
Inspect the outer bag for signs of incomplete sealing, such as gaps or leaks.
The model number is 570-2718.
Check for the serial numbers 22242489582 or 22256491864 on the kit's packaging.
Inspect the outer bag for incomplete sealing. If you find a breach, do not use the kit and contact Henry Schein for further instructions.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0511-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0511-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
