Medline recalls specific convenience kits due to potential calibration issues that could impact sterility assurance levels. Affected products include SCC RF PAIN MGMT kits and CPNB SETUP TRAY models with certain 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 several convenience kits that may have calibration issues during sterilization, potentially compromising sterility. This means the products could be contaminated and unsafe for medical use.
The equipment used to sterilize and package these kits had calibration issues, which could lead to reduced sterility assurance levels. This means the kits might not be properly sterilized and could pose a contamination risk during medical procedures.
Healthcare professionals and medical facilities that use these convenience kits for pain management or surgical procedures are most at risk. The recall affects specific models and lot numbers sold to hospitals and clinics.
Check for model numbers DYNJ56436A, DYNJ56436B, DYNJ56436C, DYNJRA1979, DYNJRA1979A, DYNJRA1979B, DYNJRA2608, or SAMPA0108. The recall includes specific lot numbers listed in the official notice.
Review the model number and lot number on the product to confirm if it is affected by this recall.
Medline identified calibration issues in the equipment used to sterilize and package these kits, which could impact the sterility assurance level.
The recall indicates a potential risk to sterility, so affected kits should not be used until the issue is resolved.
Check the model number and lot number on the product. Affected models include DYNJ56436A, DYNJ56436B, DYNJ56436C, DYNJRA1979, DYNJRA1979A, DYNJRA1979B, DYNJRA2608, and SAMPA0108 with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2090-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2090-2026 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.
