- 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) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 14039 ; 2) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 3) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 12206 ; 4) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14039 ; 5) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192-1 ; 6) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-5 ; 7) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 8) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 11020-1 ; 9) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 14813 ; 10) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15192 ; 11) SNE11SPHKC, UDI-DI: 10197106817186(each), 50197106817184(case), Lot Number: 15463-1 ; 12) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-6 ; 13) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-7 ; 14) SNE11SPHKD, UDI-DI: 10198956354616(each), 50198956354614(case), Lot Number: 15463-1 ; 15) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 6033 ; 16) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160-2 ; 17) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 10392 ; 18) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-2 ; 19) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 11020 ; 20) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1 ; 21) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 8160 ; 22) SNE12BS01B, UDI-DI: 10888439842746(each), 50888439842744(case), Lot Number: 9243-1
- Units affected
- 616 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-2949-2026
- 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