- Recalling firm
- Cardinal Health 200, LLC
- Reason for recall
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Affected products (lot / model / serial)
- 1) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15192 ; 2) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-1
- Units affected
- 80 kits
- Distribution pattern
- US Nationwide. Canada.
- Firm location
- Waukegan, IL, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2944-2026
- Recall initiated
- July 14, 2026
- FDA classification date
- August 13, 2026
- FDA report date
- August 19, 2026
- FDA event ID
- 99380
- Last updated on HTM Vibe
- August 26, 2026