Cardinal Health recalled 1,169,726 chest drainage units on December 26, 2025. The recall stems from an update to the instructions for use (IFU) clarifying that the devices are intended for adults only. Using these devices on infants may result in delayed treatment and prolonged hospitalization.
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter
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Chest drainage units are medical devices used to remove air or fluid from the pleural space in patients. They are critical in treating conditions such as pneumothorax and pleural effusion, primarily used in hospital settings.
The hazard arises when these units are used on infants, as they may not show expected signs of functionality, leading to misinterpretation by healthcare providers. This can delay necessary treatment, resulting in complications.
This recall is not part of a broader industry pattern.
The recall may affect patient treatment plans and requires immediate action from healthcare providers and patients to prevent potential health risks.
Product codes can usually be found on the device packaging or on the unit itself near the barcode or labeling.
Expect processing of refunds or returns within 4-6 weeks after contacting the manufacturer.
Keep a record of your purchase, including receipts and correspondence with Cardinal Health regarding the recall.
The recall affects several models, including Cardinal Health Sentinel Seal CDU and Thora-Seal devices, with product codes ranging from 8888571562 to 8884713900. These units were distributed globally, including the US, Brazil, Canada, and Mexico.
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