Medline recalls surgical packs with potential sterility issues due to calibration problems during sterilization. Affected models include DYNJP1050UG and DYNJP8401 with specific lot numbers.
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Medline is recalling surgical packs that may not be sterile due to calibration issues in the sterilization process. This could lead to infections if the packs are used in medical procedures.
The sterilization equipment used to package these packs had calibration issues, which could compromise the sterility assurance level. This means the packs might not be sterile when used in medical procedures, increasing infection risk.
Healthcare professionals and medical facilities that use these surgical packs. The risk is primarily for those using the packs in sterile procedures where contamination could cause infections.
Check for model numbers DYNJP1050UG or DYNJP8401 with specific lot numbers listed in the recall notice. The packs have a unique identifier (UDI-DI) and case numbers.
Look for model numbers DYNJP1050UG or DYNJP8401 and the specific lot numbers listed in the recall notice.
The recall states there is a potential risk to sterility, but the exact risk level is not specified. Medline has identified calibration issues that could impact sterility assurance.
Check for model numbers DYNJP1050UG or DYNJP8401 with the specific lot numbers listed in the recall notice.
The recall does not specify a remedy, so no action is required beyond checking if your packs are affected.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1425-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1425-2026 from Medline. 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.
