- 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) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 2) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 3) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 4) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 5) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14813 ; 6) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 7) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 8) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 9) PN36NBCH4, UDI-DI: 10198956129863(each), 50198956129861(case), Lot Number: 14813 ; 10) PN36NBCH5, UDI-DI: 10198956131538(each), 50198956131536(case), Lot Number: 14813 ; 11) PN41ACLA9, UDI-DI: 10197106346105(each), 50197106346103(case), Lot Number: 4869 ; 12) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 13) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 14) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 15) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 16) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3024 ; 17) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3916-1 ; 18) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 7748 ; 19) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8160 ; 20) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8160 ; 21) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8808-2 ; 22) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8808-2 ; 23) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243 ; 24) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243-1 ; 25) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243-1 ; 26) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 11020 ; 27) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12206 ; 28) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12206 ; 29) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12641 ; 30) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13289 ; 31) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 32) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 33) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 34) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 14813 ; 35) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 15192 ; 36) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 15192 ; 37) PN41ACLAI
- Units affected
- 52699 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-2948-2026
- 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