FDA Device recall Z-0911-2025
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE by Cardinal Health 200, citing potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0911-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-08 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Cardinal Health Presource Kits: 1 ) KIT, MAJOR ORAL SURGERY, Catalog Number: PGDHMOWOE; 2 ) ORP DENTAL PACK , Catalog Number: SENHDDPVCH; 3 ) ORP DENTAL PACK, Catalog Number: SENHDDPVCI
Reason
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Identifiers
| code_info | Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J1896M ; Catalog Number P…Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J1896M ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J3987C ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J43U76 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J46C02 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J4952G ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J74A30 ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J8064Z ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J8123Z ; Catalog Number PGDHMOWOE, UDI/DI 10888439587074 (EA)50888439587072 (CS), Lot Number J84K03 ; Catalog Number SENHDDPVCH, UDI/DI 10195594888015 (EA)50195594888013 (CS), |
|---|
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-0911-2025%22
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