FDA Medical devices recall ·
Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 recall
- Recall number
- Z-2947-2026
- Date
- (initiated July 14, 2026)
- Company / brand
- Cardinal Health 200, LLC
3651 Birchwood Dr, Waukegan, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 401311 kits
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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;
Why was it recalled?
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
3790) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 4730 ; 3791) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 2221315564 ; 3792) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 338058 ; 3793) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 4869 ; 3794) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3795) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3796) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3797) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3798) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 7784 ; 3799) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 9243-1 ; 3800) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 3024-2 ; 3801) SNE30CNRCD, UDI-DI: 10195594687052(each), 50195594687050(case), Lot Number: 3916-2 ; 3802) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243 ; 3803) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243-2 ; 3804) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 9243-2 ; 3805) SNE30CNRCE, UDI-DI: 10197106605233(each), 50197106605231(case), Lot Number: 11020 ; 3806) SNE30CNRCE, UDI-DI: 10197106605233(each), 501971066
Distribution
US Nationwide. Canada.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2947-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.