Medline Industries, LP recalled 141,971 suction catheter kits on December 24, 2025. The kits may contain a smaller catheter that can lead to serious respiratory issues. Health providers and patients must stop using the kits immediately to prevent potential harm.
A smaller open suction catheter, the 8 Fr Suction Catheter, may have been packed within the kit instead of the required 14 Fr Suction Catheter. Use of the smaller size catheter may result in hypoxia and/or respiratory failure related to partial or full airway obstruction. Airway obstruction may require immediate emergent medical intervention to prevent respiratory failure or death. Other potential outcomes include prolonged procedure, airway irritation, or prolonged dyspnea.
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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The recalled product is the Medline 14 Fr Suction Catheter Kits, SKU DYND40972. The affected lot number is 48625040001, with UDI codes 10080196033317 (each) and 40080196033318 (case). These kits were distributed across the United States and Canada.
The kits may include an 8 Fr Suction Catheter instead of the required 14 Fr size. Using the smaller catheter can cause hypoxia or respiratory failure, requiring urgent medical attention due to airway obstruction.
The recall is classified as Class II, indicating a high hazard level. There have been no specific reported incidents or injuries mentioned in the recall data.
Stop using the suction catheter kits immediately. Contact Medline Industries or your healthcare provider for guidance on returning the product and obtaining a refund.
For more information, call Medline Industries at 1-800-633-5463 or visit their website at www.medline.com.
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