Recall archive / FDA device enforcement
Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, C... — FDA record Z-1133-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cardinal Health Presource Kits: 1) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFA; 2) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFB 3) KIT,ROBOTIC HYSTERECTOMY, Catalog Number:PB4FRHWFC
- Reason
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 973,785 total units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1133-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 6701856 ; 2) PB4FRHWFA, UDI-DI:10197106527009 (each) 50197106527007 (case), Lot Number: 7331357 ; 3) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7266123 ; 4) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7331357 ; 5) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452 ; 6) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333453 ; 7) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7160530 ; 8) PB4FRHWFB, UDI-DI:10197106628096 (each) 50197106628094 (case), Lot Number: 7333452 ; 9) PB4FRHWFC, UDI-DI:10197106732311 (each) 50197106732319 (case), Lot Number: 7350003 ; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 19, 2025
- Recall initiation date
- Nov 8, 2024
- Center classification date
- Feb 10, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.