Cardinal Health 200, LLC
FDA Regulatory Profile
Cardinal Health 200, LLC appears in FDA public data with 277 recalls — including 32 Class I (most serious) —, 4 510(k) clearances, 30 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0528-2026, Class I) was initiated on March 2, 2026. Its most recent 510(k) clearance was granted on April 28, 2026.
Summary
- Total Recalls
- 277 (32 Class I)
- 510(k) Clearances
- 4
- Inspections
- 30
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0528-2026 | Class I | Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 | March 2, 2026 |
| Z-1768-2026 | Class II | Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 | February 27, 2026 |
| Z-1203-2026 | Class II | Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health S | December 26, 2025 |
| Z-0897-2026 | Class II | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universa | November 12, 2025 |
| Z-0210-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual Lumen wit | September 18, 2025 |
| Z-0211-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC Gastroduodenal Tube, | September 18, 2025 |
| Z-0207-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual Lumen, 12 | September 18, 2025 |
| Z-0206-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR | September 18, 2025 |
| Z-0208-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual Lumen Stoma | September 18, 2025 |
| Z-0209-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve CE Marke | September 18, 2025 |
| Z-1918-2025 | Class II | Kendall SCD Comfort Sleeves Knee Length Small, Pediatric - For use with Kendall SCD SmartFlow, SK | May 13, 2025 |
| Z-1917-2025 | Class II | SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kenda | May 13, 2025 |
| Z-1919-2025 | Class II | Kendall SCD Blended Comfort Sleeves Knee Length Small - For use with Kendall SCD SmartFlow SKU 8 | May 13, 2025 |
| Z-1875-2025 | Class II | Catalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumen | May 2, 2025 |
| Z-1872-2025 | Class II | Catalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumen | May 2, 2025 |
| Z-1873-2025 | Class II | Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen | May 2, 2025 |
| Z-1871-2025 | Class II | Catalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumen | May 2, 2025 |
| Z-1870-2025 | Class II | Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs | May 2, 2025 |
| Z-1874-2025 | Class II | Catalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumen | May 2, 2025 |
| Z-1133-2025 | Class II | Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBO | November 8, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253243 | Cardinal Health Poly Reinforced Surgical Gown | April 28, 2026 |
| K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | March 24, 2016 |
| K150151 | SmartGownTM surgical gown | May 21, 2015 |
| K061308 | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, | June 5, 2006 |