Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
283 recalls found for Medline Industries, LP. Check if any of your products are affected.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries recalled 420 Sterile Radiology Procedure Kits, Model DYNDH1491B, distributed nationwide in Minnesota after a potential breach in sterile pouch packaging. The defect may compromise product sterility. Stop using the kit immediately and contact Medline or your healthcare provider for instructions.
Medline Industries is recalling 14,379 kits nationwide that include Olympus biopsy valves. The recall follows reports of rubber fragments detaching from the valves during use. Healthcare providers and patients should stop using the affected kits and follow Medline’s recall instructions.
Olympus biopsy valves in Medline Industries, LP thoracic robotic biopsy valve kits are recalled nationwide. The recall covers 14,379 kits distributed across 13 states. Rubber fragments may detach from single-use biopsy valves, creating a risk of a foreign body in the patient’s tracheobronchial tree and possible inflammation or hypoxia. Healthcare providers and patients should stop using the device
Medline Industries, LP recalled 14,379 Airway Exam Kits containing Olympus biopsy valves nationwide. The recall cites rubber fragments detaching from the slit of single-use biopsy valves. Potential harm includes a foreign body in the patient’s tracheobronchial tree, inflammatory response, hypoxia, and longer procedures. Providers and patients should stop using the kit and follow recall directions.
Medline recalled 108,971 units of Puracol MSC8522 and Puracol Plus MSC8622EP collagen wound dressings nationwide in the United States, with distribution to Mexico and Panama. Elevated endotoxin levels were identified in affected lots. Stop using the dressings and follow recall instructions provided by Medline or your healthcare provider.
Medline Industries recalls 2,894 Aqua-Seal Chest Drainage Units from Cardinal Health after updating IFUs to specify adult patients 18 years and older. The devices were distributed worldwide, including California, Chile and Panama. The update clarifies intended patient population and requires action from healthcare providers to stop use until further notice.
Medline Industries recalled 23,568 surgical drapes on January 28, 2026, after reports of fabric delamination during laundering. The delamination may delay patient care and increase the risk of infection. Health care providers and facilities must stop using these drapes immediately and follow the manufacturer's instructions for a remedy.
Medline Industries recalled 31,848 dialysis dressing change kits on January 8, 2026. The recall follows reports of defective silicone seals on Tego Connectors that may occlude fluid paths. This defect can delay therapy and expose patients to biological contaminants.
Medline Industries recalled 2,020 dialysis kits on January 8, 2026, due to defective silicone seals. The seals may dome or tear, leading to fluid leaks and contamination. Patients and healthcare providers should stop using these kits immediately.
Medline Industries recalled 516 medical kits on January 8, 2026, due to issues with Tego Connectors. The silicone seal may tear or dome, posing a high risk of therapy interruption and exposure to contaminants. Healthcare providers must stop using these devices immediately and follow recall instructions.
Medline Industries recalled 150 dialysis convenience kits on January 8, 2026, due to silicone seal defects. Affected kits may obstruct fluid paths and risk exposure to biological contaminants.
Medline Industries recalled 14,525 dialysis convenience kits on January 8, 2026. The recall affects multiple product SKUs due to potential silicone seal failures. These issues may cause therapy delays or exposure to contaminants.
Medline Industries recalled 1,212 kits containing Tego Connectors on January 8, 2026. The recall stems from issues with silicone seals that may cause occluded fluid paths. Users may experience delays in therapy or exposure to contaminants due to this defect.
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, LP recalled 684 medical convenience kits on January 7, 2026. The recall affects the LVAD Driveline Tray and the KIT Surg Onc Insert Cent. Venou due to calibration issues impacting sterility. Health providers and patients should stop using these products 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.