Stradis Healthcare recalls surgical pain trays with item #570-1482 due to potential sterility breaches from incomplete bag sealing. Affected units sold with specific UDI/DI numbers.
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 surgical pain trays that may have incomplete bag sealing, risking sterility breaches during medical procedures. This could lead to infections if the tray is used without proper sterility.
The trays may have outer bags that aren't sealed properly during manufacturing. This could allow contamination, breaking the sterility of the surgical kit and increasing infection risk during procedures.
Healthcare professionals using the surgical pain tray with item number 570-1482 are most at risk. Patients receiving procedures with this tray could face infection risks if sterility is compromised.
Check for item number 570-1482 on the tray. Look for UDI/DI (case) M75257014821 or UDI/DI (kit) M75257014820 on the packaging. Serial numbers starting with 22235489736 indicate affected units.
Verify the item number, UDI/DI codes, and serial numbers on the tray packaging to confirm if it's affected.
The recall is for potential sterility breaches, which could increase infection risk during surgery. However, the hazard is not described as causing serious injury in normal use.
Check for item number 570-1482, UDI/DI (case) M75257014821, UDI/DI (kit) M75257014820, or serial number 22235489736 on the packaging.
The recall does not specify a remedy, so affected users should check product details and contact Stradis Healthcare for further 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-0505-2023 — Stradis Healthcare Stradis Healthcare Hello, I own a Stradis Healthcare that is covered by recall Z-0505-2023 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.
