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Cardinal Health 200, LLC

Cardinal Health 200, LLC Recalls

All product recalls associated with Cardinal Health 200, LLC.

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Recall Summary

Total Recalls

76

Past Year

11

Class I (Serious)

0

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 76 recalls

ChemoPlus gowns: Product Code Product Description CT5500T... (Cardinal Health 200, LLC) – mislabeling (2025)

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.

FDANov 12, 2025Nationwide• Cardinal Health 200, LLC

Salem Sump PVC Tubes (Cardinal Health) – Valve Breakage Risk (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.

FDASep 18, 2025Nationwide• Cardinal Health 200, LLC

SCD Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

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FDAMay 13, 2025AK, CA, FL +2 more• Cardinal Health 200, LLC

Kendall SCD Blended Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

FDAMay 13, 2025AK, CA, FL +2 more• Cardinal Health 200, LLC

Kendall SCD Comfort Sleeve (Cardinal Health) – Software Pressure Error (2025)

Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.

FDAMay 13, 2025AK, CA, FL +2 more• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Umbilical Vessel Catheter (Cardinal Health) – Sterility Compromise (2025)

Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates.

FDAMay 2, 2025Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catal...

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

FDANov 8, 2024Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Convertor Isolation Gown, AAMI Level 3 protection, Produc...

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.

FDANov 1, 2024Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolat...

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.

FDANov 1, 2024Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Ca...

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.

FDASep 25, 2024Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 1...

The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made.

FDAJul 24, 2024Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Presource kits and trays, labeled as: 1) ANGIOGRAPHY PA...

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.

FDAMay 29, 2024Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: CardinalHealth Curity Flexible Adhesive Bandage X-Large 2...

Potential contamination of the product with latex adhesive residual.

FDAApr 17, 2024Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain...

Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.

FDAMar 27, 2024Nationwide• Cardinal Health 200, LLC

Cardinal Health 200, LLC: Jackson-Pratt Universal Connector PVC Tubing Anti Reflux ...

Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.

FDAMar 27, 2024Nationwide• Cardinal Health 200, LLC