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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.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 FABRIC REINF SURG GOWN 2XL, Item Code 9571
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 FABRIC REINF SURG GOWN XL, Item Code 9541
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls ROYALSILK 3XLARGE/XLONG, Gown. Item Code 95998
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls ROYALSILK 2XLARGE, Gown. Item Code 9578
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls ROYALSILK LARGE, Gown. Item Code 9518
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 NONREINF SURG GOWN 3XL BNS, Item Code 9585N
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 NONRNF SURG GWN 2XL XLNG BNS, Item Code 9575ELNA
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 NONREIN SURGGOWN BNS XL, Item Code 9545NC
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 NONREIN SURG GOWN L BNS, Item Code 9515NB
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 FABRIC REINF SURG GOWN XL NS, Item Code 9541NA
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 NONREIN SCRBNURGOWN BNS L, Item Code 90270NB
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 NON-RNF SURG GOWN 3XL LONG, Item Code 95995N
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls ROYALSILK 3XLARGE/XLONG NS, Gown Item Code 95998N
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 ROYALSILK SURGGOWN BNS 2XL, Item Code 9578NB
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 ROYALSILK SURGGOWN BNS XL, Item Code 9548NC
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 ROYALSILK SURGGOWN BNS L, Gown. Item Code 9518NC
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 ROYALSILK SCRBNURGOWN BNS XL, Gown. Item Code 90380NC
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 ROYALSILK SCRBNURGOWN BNS L, Gown. Item Code 90280NC
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 NONREIN SCRBNURGOWN BNS XL, Gown. Item Code 90370NB
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 FABRNF SCRUB SURG GWN XL NS, Gown. Item Code 91070NB
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 FABREINF SCRUB SURG GWN L NS, Gown. Item Code 90970NA
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 FABREINF SURG GOWN L NS, Item Code 9511NB
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 NON-REINF SURG GOWN 2XL BNS, Item Code 9575NB
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
February 12, 2020Medical DevicesFDA
Cardinal Health recalls AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA
Hazard: The gowns contain an unknown level of bioburden, unknown microbiological flora, and unknown particulate contamination.
January 1, 2020Medical DevicesFDA
Cardinal Health Inc. recalls Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent Sy
Hazard: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
January 1, 2020Medical DevicesFDA
Cardinal Health Inc. recalls Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent System devices are designed to deliver a flexi
Hazard: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
January 1, 2020Medical DevicesFDA
Cardinal Health Inc. recalls S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a s
Hazard: Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI information on the IFU. The correct classification is "MRI Conditional" not "MRI Safe".
October 2, 2019DrugsFDA
Cardinal Health dba Specialty Pharmaceutical Services recalls Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactur
Hazard: Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
January 16, 2019Medical DevicesFDA
Cardinal Health Inc. recalls Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on pati
Hazard: The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.