Recall Z-2947-2026— Cardinal Health 200, LLC

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2026-07-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC27; 2) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC28; 3) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2C; 4) CHI STD NEURO CRANI OPT 2 , Catalog Number: CHIP99NC2D; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC2D; 6) KIT, IUS NASAL , Catalog Number: PECGNSBOA; 7) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHB; 8) KIT,ENT , Catalog Number: PEMIEPHP2; 9) KIT,ENT , Catalog Number: PEMIEPHP3; 10) KIT,ENT , Catalog Number: PEMIEPHPB; 11) KIT, NASAL SINUS P, Catalog Number: PEV2CL016; 12) KIT, ENT FESS , Catalog Number: PEV2FSNYC;. Reason: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels..

Recalling firm

Cardinal Health 200, LLC

Classification

Class II

Status

Ongoing

Initiated

2026-07-14

Firm location

Waukegan, IL, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.