Medline Industries recalled 4,853 surgical kits on January 7, 2026 due to potential sterility issues. Calibration problems with sterilization equipment could affect safety. Patients and providers must stop using these kits immediately.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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Medline Convenience Kits are pre-packaged surgical kits designed for various medical procedures, including ophthalmology and breast surgeries. They are used in healthcare settings for efficiency and sterility during operations.
Calibration issues in the sterilization equipment could lead to compromised sterility, increasing the risk of infections in patients. Proper sterilization is critical to ensure patient safety during surgical procedures.
This recall is not part of a broader industry pattern.
The recall necessitates immediate action by healthcare providers, potentially disrupting scheduled procedures and requiring the use of alternative sterile kits.
Model numbers and lot numbers can typically be found on the packaging or label affixed to the kit.
Expect processing for refunds or replacements to take approximately 4-6 weeks after returning the product.
Keep records of all communications with Medline, including emails and phone call notes, along with any receipts or shipping confirmations related to the return.
The recall involves 35 different surgical kits, including models DYKMBNDL104 and DYNJ17219C. These products were distributed worldwide, including across the U.S.
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