FDA Device recall Z-1128-2025
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA
- FDA Device
- Class II
- ongoing
- Published 2025-02-19
On 2025-02-19 the FDA classified a Class II recall of Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA by Cardinal Health 200, citing potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1128-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-08 |
| Published | 2025-02-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Cardinal Health Presource Kits: 1) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFA; 2) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFB; 3) UROLOGY ROBOTIC PACK, Catalog Number:SOT4FRUWFC
Reason
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Identifiers
| code_info | 1) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7266123 ; 2) SOT4FRUWFA, UDI-D…1) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7266123 ; 2) SOT4FRUWFA, UDI-DI:10197106526187 (each) 50197106526185 (case), Lot Number: 7331357 ; 3) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7266123 ; 4) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333452 ; 5) SOT4FRUWFB, UDI-DI:10197106627891 (each) 50197106627899 (case), Lot Number: 7333453 ; 6) SOT4FRUWFC, UDI-DI:10197106732304 (each) 50197106732302 (case), Lot Number: 7350031 ; |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1128-2025%22
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