Medline Industries LP recalls 70+ medical convenience kits due to calibration issues in sterilization equipment that could impact sterility assurance levels. Products include ENT, head and neck, thyroidectomy, and other surgical kits with specific model numbers and 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 Industries has recalled 70 different medical convenience kits because calibration problems in the sterilization equipment used to package them might reduce the sterility assurance level. This means the kits could be contaminated, but no injuries have been reported. Affected products include ENT, head and neck, and surgical kits with specific model numbers and lot numbers.
The sterilization equipment used to package these kits had calibration issues that could impact the sterility assurance level (SAL). This means the kits might not be properly sterilized, potentially leading to contamination if used in procedures.
Healthcare professionals and medical facilities that use these kits are most at risk. The recall affects 70 different medical convenience kits used in surgeries and procedures.
Check the model number and lot number on the kit. Affected kits include ENT, head and neck, thyroidectomy, and surgical kits with specific model numbers listed in the recall (e.g., CDS983069G, DYKMBNDL156, DYNJ41169).
Identify the model number and lot number on the kit to see if it's affected. Affected kits include specific ENT, head and neck, and surgical kits with model numbers listed in the recall.
If you have an affected kit, contact Medline Industries at 1-800-877-7575 to get instructions on what to do next.
No injuries have been reported related to this recall.
Check the model number and lot number on the kit. Affected kits include specific ENT, head and neck, and surgical kits with model numbers listed in the recall (e.g., CDS983069G, DYKMBNDL156, DYNJ41169).
Contact Medline Industries at 1-800-877-7575 to get instructions on what to do next.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1394-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1394-2026 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.