FDA Device recall Z-2944-2026
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
- FDA Device
- Class II
- ongoing
- Published 2026-08-19
On 2026-08-19 the FDA classified a Class II recall of Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB by Cardinal Health 200, citing procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2944-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-14 |
| Published | 2026-08-19 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
Reason
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Identifiers
| code_info | 1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21…1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-10-14 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI , Catalog Number: PGVMDVBWU
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE , Catalog Number: PGCGLCBAC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200 - Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH , Catalog Number: PB63VHSTC
FDA Device · Class II · 2026-10-07 · Cardinal Health 200
All Cardinal Health 200 recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2944-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.