Stradis Healthcare recalls medical procedure trays with possible incomplete sterilization seals that could breach sterility. Affected items include specific model numbers and serials sold through Henry Schein.
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 medical procedure trays that may have incomplete sterilization seals. This could lead to breaches in the sterility of the kits, posing a risk during surgical procedures.
The trays may have outer bags that are incompletely sealed during manufacturing. This could allow contamination of the sterile kit, potentially leading to infections during medical procedures.
Healthcare professionals using the recalled medical trays and kits are most at risk. The recall affects specific model numbers and serials sold through Henry Schein.
Check for item number 570-2779 on Henry Schein OMFS products. Look for UDI/DI case number H65857027791 or kit number M75257027790. Serial numbers 22262489585 and 22270490757 are also affected.
Verify the item number, UDI/DI codes, and serial numbers listed in the recall notice to confirm if your product is affected.
The recalled model is HENRY SCHEIN, OMFS, Item No. 570-2779.
Check for UDI/DI case number H65857027791, UDI/DI kit number M75257027790, or serial numbers 22262489585 and 22270490757.
The recall notice does not specify a remedy; affected users should check the product details to determine if they need to stop using the item.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0515-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0515-2023 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.
