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Cardinal Health Recalls
316 recalls on record · January 30, 2013 to September 3, 2025 · Drugs, Food & Beverage, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 12, 2016Medical DevicesFDA
Cardinal Health recalls BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Ste
Hazard: Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard defines a specific test method that quantifies the rate of flame propagation against a minimum value using an engineered test fixture. The method requires that the test be performed on different orientations of the film (machine direction and cross direction). The machine direction is defined by the manufacturing process generating the film. The formed film exits the machine moving in the machine direction. The cross direction is at 90 degrees to the machine direction. The more rapid burning direction defines the results of the test (either a pass or fail). The products being recalled failed when tested in the machine direction with a result of 1.9-2.0 inches/second versus a limit of 1.2 inches/second. They passed by self-extinguishing when tested in the cross direction.
September 7, 2016Medical DevicesFDA
Cardinal Health recalls The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Me
Hazard: Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has identified a potential customer/user safety risk associated with the missing locking clasp component.
April 13, 2016Medical DevicesFDA
Cardinal Health recalls Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of
Hazard: Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp.
October 28, 2015Medical DevicesFDA
Cardinal Health recalls Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand fo
Hazard: Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.
April 22, 2015DrugsFDA
Cardinal Health recalls Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated ship
Hazard: Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
February 11, 2015Medical DevicesFDA
Cardinal Health recalls Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is us
Hazard: A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube.
April 3, 2013Medical DevicesFDA
Cardinal Health recalls Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 60 Count/100 Capacity; Sterile; Removable Numbered Foam Block
Hazard: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
April 3, 2013Medical DevicesFDA
Cardinal Health recalls Needle Counters with Blade Disarmer; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block;
Hazard: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
April 3, 2013Medical DevicesFDA
Cardinal Health recalls Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/80 Capacity; Sterile; Double Removable Numbered Foam Blocks (Cat. No. 3F
Hazard: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
April 3, 2013Medical DevicesFDA
Cardinal Health recalls Needle Counters; 12.2 x 10.5 x 3.5 cm; 40 Count/70 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat.
Hazard: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
April 3, 2013Medical DevicesFDA
Cardinal Health recalls Needle Counters with Blade Disarmer; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Cat
Hazard: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
April 3, 2013Medical DevicesFDA
Cardinal Health recalls Needle Counters; Sterile; Foam Strip; 12.2 x 10.5 x 1.7 cm; 30 Count/60 Capacity; Sterile; Foam Strip; Magnetic Area (Ca
Hazard: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
April 3, 2013Medical DevicesFDA
Cardinal Health recalls Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 15 Count/30 Capacity; Sterile; Removable Numbered Foam Block;
Hazard: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
April 3, 2013Medical DevicesFDA
Cardinal Health recalls Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block;
Hazard: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
April 3, 2013Medical DevicesFDA
Cardinal Health recalls Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat.
Hazard: Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
January 30, 2013Food & BeverageFDA
Cardinal Health recalls Dairy Aid Lactase Enzyme Supplement, Caplet, 3,000 FCC Units, 60 caplets, OTC, Repackaged by: Cardinal Health, Zanesvill
Hazard: The firm discovered that the labeling bears an incorrect strength of 9,000 FCC Units per caplet instead of 3,000 FCC units per caplet.