Medline recalls 307 convenience kits for potential sterility issues due to calibration problems in sterilization equipment. Products include cochlear supplement kits, bronchoscopy sets, and ENT head/neck kits with specific model numbers and lot numbers. Consumers should check their kits against the list and contact Medline for details.
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 307 convenience kits that may have been affected by calibration issues in sterilization equipment. This could impact the sterility assurance level of the products, meaning they might not be safe for medical use. The recall includes specific model numbers and lot numbers for various kits used in ENT and bronchoscopy procedures.
The calibration issues in the sterilization equipment used to package these kits could lead to a potential decrease in the sterility assurance level. This means the products might not be sterile when used, which could pose a risk of infection during medical procedures.
Healthcare professionals and medical facilities that use these convenience kits for ENT, bronchoscopy, and cochlear procedures are most at risk. The recall affects products with specific model numbers and lot numbers listed in the official recall notice.
Check if your kit has a model number listed in the recall (e.g., CDS983069G, DYKE1456D, DYKMBNDL156) and a lot number from the provided list (e.g., 21HBO921, 24CBK289). The recall includes specific product variants with unique model and lot combinations.
Verify your kit's model number and lot number against the list provided in the recall notice to determine if it is affected.
Reach out to Medline Industries for further assistance or to confirm if your specific kit is part of the recall.
The recall indicates potential issues with sterility assurance due to calibration problems, so they should not be used until the recall is addressed.
Compare your kit's model number and lot number with the list of affected products provided in the official recall notice.
Contact Medline Industries directly for instructions on how to handle the affected kit, which may include returning it or using a replacement.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-2097-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-2097-2026 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.
