Cardinal Health 200, LLC

49 FDA enforcement actions

49 Total Recalls

1 Class I

48 Class II

0 Class III

Firm Details

Product Types: device
States: IL

All Recalls

Class II: Risk 12/26/2025 device

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.
Class II: Risk 11/12/2025 device

Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
Class II: Risk 09/18/2025 device

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Class II: Risk 09/18/2025 device

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Class II: Risk 09/18/2025 device

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Class II: Risk 09/18/2025 device

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Class II: Risk 09/18/2025 device

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Class II: Risk 09/18/2025 device

Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
Class II: Risk 05/13/2025 device

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class II: Risk 05/13/2025 device

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class II: Risk 05/13/2025 device

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class II: Risk 05/02/2025 device

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II: Risk 05/02/2025 device

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II: Risk 05/02/2025 device

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II: Risk 05/02/2025 device

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II: Risk 05/02/2025 device

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II: Risk 05/02/2025 device

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II: Risk 11/08/2024 device

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II: Risk 11/01/2024 device

Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
Class II: Risk 11/01/2024 device

Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.
Class I: Dangerous 09/25/2024 device

Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector.
Class II: Risk 07/24/2024 device

The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Class II: Risk 07/24/2024 device

The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.
Class II: Risk 05/29/2024 device

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Class II: Risk 05/29/2024 device

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Class II: Risk 05/29/2024 device

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Class II: Risk 05/29/2024 device

Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical¿ supplied finished kits. Merit Medical¿ supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical¿ kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
Class II: Risk 04/17/2024 device

Potential contamination of the product with latex adhesive residual.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.