Cardinal Health 200, LLC
Complete recall history across all FDA and CPSC categories — 275 total recalls
Cardinal Health 200, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (275)
FDA medical device enforcement actions by Cardinal Health 200, LLC. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 26, 2025 | Chest Drainage Units and Accessories: Product Code Description 1. 88885... | The firm is updating the IFU to clarify the intended patient population for t... | Class II |
| Nov 12, 2025 | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Co... | Affected gowns have the incorrect expiration date on the product packaging. P... | Class II |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stoma... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due t... | Class II |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SAL... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due t... | Class II |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due t... | Class II |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" P... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due t... | Class II |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stoma... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due t... | Class II |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Si... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due t... | Class II |
| May 13, 2025 | Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Ken... | Incorrect software logic may cause frequent E1 errors (system high pressure).... | Class II |
| May 13, 2025 | Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendal... | Incorrect software logic may cause frequent E1 errors (system high pressure).... | Class II |
| May 13, 2025 | SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves w... | Incorrect software logic may cause frequent E1 errors (system high pressure).... | Class II |
| May 2, 2025 | Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen | Packaging defect may compromise sterility of the product. Use of a non-steril... | Class II |
| May 2, 2025 | Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen | Packaging defect may compromise sterility of the product. Use of a non-steril... | Class II |
| May 2, 2025 | Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-steril... | Class II |
| May 2, 2025 | Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-steril... | Class II |
| May 2, 2025 | Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen | Packaging defect may compromise sterility of the product. Use of a non-steril... | Class II |
| May 2, 2025 | Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and... | Packaging defect may compromise sterility of the product. Use of a non-steril... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCT... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) OPHTHALMOLOGY ENDO DCR XTRS PK, Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Numbe... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 1, Catalog Number:... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number:... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) LARYNGOSCOPY PACK, Catalog Number: SEN11... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHI... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) ORTHO PLASTIC MICROVASCULAR PK , Catalog N... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Nu... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT, CAROTID ENDARTERECTOMY, Catalog Numb... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET09... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) KIT, FETAL SURGERY, Catalog Number PB11F... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFH... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPB... | Potential endotoxin contamination in non-sterile surgical strips and patties ... | Class II |
| Nov 8, 2024 | Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog N... | Potential for endotoxin contamination in non-sterile surgical strips and patt... | Class II |
| Nov 1, 2024 | Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT61... | Isolation Gowns were manufactured with raw materials that may fail the hydros... | Class II |
| Nov 1, 2024 | Cardinal Health SMS Elastic Cuff Thumbhook Level 3 Isolation Gown, Full-Back,... | Isolation Gowns were manufactured with raw materials that may fail the hydros... | Class II |
| Sep 25, 2024 | Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 118... | Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Sy... | Class I |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 4... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to i... | Class II |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve,... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to i... | Class II |
| May 29, 2024 | Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number S... | Cardinal Health is following the FDA's recommendations regarding the disposit... | Class II |
| May 29, 2024 | Presource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Cata... | Cardinal Health is following the FDA's recommendations regarding the disposit... | Class II |
| May 29, 2024 | Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number ... | Cardinal Health is following the FDA's recommendations regarding the disposit... | Class II |
| May 29, 2024 | Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Cata... | Cardinal Health is following the FDA's recommendations regarding the disposit... | Class II |
| Apr 17, 2024 | CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9... | Potential contamination of the product with latex adhesive residual. | Class II |
| Mar 27, 2024 | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF ... | Cardinal Health is issuing a lot number specific voluntary removal of Jackson... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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