FDA Device recall Z-1137-2025
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA
- 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) ACDF PACK, Catalog Number: SNEHBACSCA 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-1137-2025 |
| 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) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCB
Reason
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Identifiers
| code_info | 1) ACDF PACK, UDI-DI:10195594353926 (each) 50195594353924 (case), Lot Number: J6935H; 2) ACDF PACK, UDI-DI:10195594439…1) ACDF PACK, UDI-DI:10195594353926 (each) 50195594353924 (case), Lot Number: J6935H; 2) ACDF PACK, UDI-DI:10195594439880 (each) 50195594439888 (case), Lot Number: J65K18; |
|---|
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-1137-2025%22
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