Stradis Healthcare recalls dental surgical packs with potential sterility breaches due to incomplete sealing. Affected items have specific serial numbers and item codes. Consumers should check their packs 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 dental surgical packs that may have incomplete sealing of the outer bag, risking a breach in sterility. This could lead to infections during medical procedures if the kit is used without proper sterilization.
The outer bag may not seal properly during manufacturing, creating a potential pathway for contamination. If the kit is used without proper sterilization, it could introduce pathogens into the surgical site, increasing infection risk.
Dental professionals and hospitals using the recalled dental surgical packs. The risk is highest for those using the packs in sterile environments where contamination could lead to infections.
Check for the item number 41236SDSP, UDI/DI code M75241236SDSP1 (case) or M75241236SDSP0 (kit), and serial numbers starting with 22235489632.
Look for the item number 41236SDSP, UDI/DI codes M75241236SDSP1 or M75241236SDSP0, and serial numbers starting with 22235489632.
The outer bag may not seal properly during manufacturing, potentially breaching sterility and increasing infection risk during medical procedures.
Check for the item number 41236SDSP, UDI/DI codes M75241236SDSP1 (case) or M75241236SDSP0 (kit), and serial numbers starting with 22235489632.
The recall does not specify a remedy, so contact Stradis Healthcare directly for guidance.
We’ve drafted a message you can send Stradis Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0497-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0497-2023 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.