Medline Industries, LP recalled 551 units of convenience kits on January 7, 2026. Calibration issues in sterilization equipment may affect product sterility. Healthcare providers and patients must stop using the 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 sets of medical devices used in various healthcare settings to facilitate procedures. They are designed for quick and easy access to necessary tools during surgeries and other medical interventions.
Calibration issues in the sterilization equipment may lead to insufficient sterility assurance, potentially allowing pathogens to survive on the devices. This increases the risk of infection for patients.
This recall is not part of a broader industry pattern.
The recall necessitates immediate action from healthcare providers to ensure patient safety, potentially disrupting medical procedures. It emphasizes the importance of product sterility in medical devices.
Model and lot numbers can typically be found on the packaging or the product itself, often near the barcode or on a label attached to the device.
Expect refund processing to take approximately 4-6 weeks after contacting Medline for instructions.
Keep records of all communications with Medline, including dates, times, and details of your requests. Maintain copies of receipts or proof of purchase if available.
The recall affects two models: ANCILLARY PACK-LF (Model Number: DYNJ0185290G) and OPEN HEART ANESTHESIA ICC-A (Model Number: DYNJ905567A). These products were distributed worldwide, including across the U.S. No specific price was mentioned.
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