Medical Device Oct 29, 2025
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 FDA: Ongoing Cardinal Health 200, LLC
Medical Device Oct 29, 2025
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 FDA: Ongoing Cardinal Health 200, LLC
Medical Device Oct 29, 2025
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 FDA: Ongoing Cardinal Health 200, LLC
Medical Device Jun 18, 2025
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class II FDA: Completed Cardinal Health 200, LLC
Medical Device Jun 18, 2025
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class II FDA: Completed Cardinal Health 200, LLC
Medical Device Jun 18, 2025
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Class II FDA: Completed Cardinal Health 200, LLC
Medical Device Jun 4, 2025
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 FDA: Ongoing Cardinal Health 200, LLC
Medical Device Jun 4, 2025
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 FDA: Ongoing Cardinal Health 200, LLC
Medical Device Jun 4, 2025
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 FDA: Ongoing Cardinal Health 200, LLC
Medical Device Jun 4, 2025
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 FDA: Ongoing Cardinal Health 200, LLC
Medical Device Jun 4, 2025
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 FDA: Ongoing Cardinal Health 200, LLC
Medical Device Jun 4, 2025
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 FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Feb 19, 2025
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Jan 22, 2025
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Medical Device Jan 22, 2025
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Class II FDA: Ongoing Cardinal Health 200, LLC
Understanding this recall history This page summarizes recall records in which the official source identifies Cardinal Health 200, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.