Cardinal Health 200, LLC
FDA Regulatory Profile
Cardinal Health 200, LLC appears in FDA public data with 297 recalls — including 32 Class I (most serious) —, 4 510(k) clearances, 30 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-3101-2026, Class II) was initiated on Jul 29, 2026. Its most recent 510(k) clearance was granted on Apr 28, 2026.
Summary
- Total Recalls
- 297 (32 Class I)
- 510(k) Clearances
- 4
- Inspections
- 30
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3101-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO | Jul 29, 2026 |
| Z-3098-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI | Jul 29, 2026 |
| Z-3099-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXIL | Jul 29, 2026 |
| Z-3105-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHON | Jul 29, 2026 |
| Z-3097-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOT | Jul 29, 2026 |
| Z-3095-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN | Jul 29, 2026 |
| Z-3103-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI | Jul 29, 2026 |
| Z-3100-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT | Jul 29, 2026 |
| Z-3096-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG | Jul 29, 2026 |
| Z-3094-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN L | Jul 29, 2026 |
| Z-3104-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLM | Jul 29, 2026 |
| Z-3102-2026 | Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBO | Jul 29, 2026 |
| Z-2943-2026 | Class II | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30SPBCC | Jul 14, 2026 |
| Z-2947-2026 | Class II | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) C | Jul 14, 2026 |
| Z-2948-2026 | Class II | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) | Jul 14, 2026 |
| Z-2945-2026 | Class II | Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT | Jul 14, 2026 |
| Z-2942-2026 | Class II | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRA | Jul 14, 2026 |
| Z-2946-2026 | Class II | Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2) P | Jul 14, 2026 |
| Z-2944-2026 | Class II | Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB | Jul 14, 2026 |
| Z-2949-2026 | Class II | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) | Jul 14, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253243 | Cardinal Health Poly Reinforced Surgical Gown | Apr 28, 2026 |
| K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | Mar 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, | Jun 5, 2006 |