FDAFDA recall Z-2942-2026 · Aug 19, 2026

Cardinal Health 200, LLC: Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT recall

Recall found

Product

Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) E BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) E BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) E BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) E BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) E BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) E BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,

Reason for recall

Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.

What to do

FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.

Recall details

FDA classification: Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Status: Ongoing
Codes, lots and dates: 1) 21-4720B, UDI-DI: 10888439934663(each), 50888439934661(case), Lot Number: 94970 ; 2) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10339 ; 3) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10586 ; 4) PECGMLBOB, UDI-DI: 10197106067406(each), 50197106067404(case), Lot Number: 4366 ; 5) PECGNAAU8, UDI-DI: 10197106967706(each), 50197106967704(case), Lot Number: 12206 ; 6) PECGNAAUJ, UDI-DI: 10197106894514(each), 50197106894512(case), Lot Number: 11851 ; 7) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14813 ; 8) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14039 ; 9) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 8160-1 ; 10) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 3747 ; 11) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 12) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 13) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 14) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 15) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 16) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 12641 ; 17) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 13289 ; 18) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 19) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 20) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 21) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 22) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10586 ; 23) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11851 ; 24) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 12641 ; 25) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-4 ; 26) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: N/A ; 27) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-5 ; 28) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-7 ; 29) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15192 ; 30) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15192 ; 31) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463 ; 32) PN21OTMC6, UDI-DI: 10195594763718(each), 50195594763716(case), Lot Number: 3024 ; 33) PN21OTMC7, UDI-DI: 10197106267660(each), 50197106267668(case), Lot Number: 6033 ; 34) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 4730 ; 35) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 93845 ; 36) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3024 ; 37) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-1 ; 38) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-2 ; 39) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-3 ; 40) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7390 ; 41) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7390-1 ; 42) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7748 ; 43) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7784-1 ; 44) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 8160-1 ; 45) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7784-2 ; 46) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 9243 ; 47) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 8160-1 ; 48) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 9243-2 ; 49) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 9243-2 ; 50) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 11020 ; 51) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 9243-2 ; 52) PN33CRMYB, UDI-DI: 10197106340240(each), 50197106340248(case), Lot Number: 7784-1 ; 53) PN33CRMYB, UDI-DI: 10197106340240(each), 50197106340248(case), Lot Number: 9243-1 ; 54) PN33CRMYB, UDI-DI: 10197106340240(each), 50197106340248(case), Lot Number: 9243-1 ; 55) PN36NBCHB, UDI-DI: 10197106225400(each), 50197106225408(case), Lot Number: 14039 ; 56) PN36NBCHB, UDI-DI: 10197106225400(each), 50197106225408(case), Lot Number: 14039 ; 57) PN40CKC27, UDI-DI: 10198956266001(each), 50198956266009(case), Lot Number: 15463 ; 58) PN40CKC27, UDI-DI: 10198956266001(each), 50198956266009(case), Lot Number: 12206 ; 59) PN40CKC28, UDI-DI: 10198956278189(each), 50198956278187(case), Lot Number: 15463-5 ; 60) PN40CKC28, UDI-DI: 10198956278189(each), 50198956278187(case), Lot Number: 15463-1 ; 61) PN40CKC28, UDI-DI: 10198956278189(each), 50198956278187(case), Lot Number: 12206 ; 62) PN40CKC29, UDI-DI: 10198956435377(each), 50198956435375(case), Lot Number: 15463-6 ; 63) PN40CKC29, UDI-DI: 10198956435377(each), 50198956435375(case), Lot Number: 15463-4 ; 64) PN40CKC29, UDI-DI: 10198956435377(each), 50198956435375(case), Lot Number: 15463 ; 65) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 7044 ; 66) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 7044 ; 67) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 6865 ; 68) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160-1 ; 69) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 9243 ; 70) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160-2 ; 71) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 9243 ; 72) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 2390 ; 73) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 2083366 ; 74) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 93845 ; 75) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 93845 ; 76) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 1103085 ; 77) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4869 ; 78) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4730 ; 79) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 7390 ; 80) PN40CKCFC, UDI-DI: 7784 (each), 10195594679934(case), Lot Number: 50195594679932; 81) PN40CKCFC, UDI-DI: 8160 (each), 10195594679934(case), Lot Number: 50195594679932; 82) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8808 ; 83) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 9243 ; 84) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 2390 ; 85) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 3747 ; 86) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 596378 ; 87) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4366 ; 88) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4730 ; 89) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4869-2 ; 90) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 7044 ; 91) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160 ; 92) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160 ; 93) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160 ; 94) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8808-2 ; 95) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 94970 ; 96) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 3024 ; 97) PNCGLLBMB, UDI-DI: 10195594635459(each), 50195594635457(case), Lot Number: 3916-3 ; 98) PNCGLLBMB, UDI-DI: 10195594635459(each), 50195594635457(case), Lot Number: 1726 ; 99) PNCGLLBMB, UDI-DI: 10195594635459(each), 50195594635457(case), Lot Number: 2390 ; 100) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 4730 ; 101) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 7390-1 ; 102) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 7784-1 ; 103) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 7784-2 ; 104) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 7784-2 ; 105) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 8160-2 ; 106) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 9243-1 ; 107) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 9243-2 ; 108) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 10339 ; 109) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 10392 ; 110) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 10586 ; 111) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 12206 ; 112) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 13289 ; 113) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 9243 ; 114) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 9243-1 ; 115) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 9243-2 ; 116) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 11020 ; 117) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 9243-1 ; 118) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 12206 ; 119) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 11020 ; 120) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 13289 ; 121) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 13673 ; 122) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 14813 ; 123) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15192-1 ; 124) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15192-1 ; 125) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463 ; 126) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-2 ; 127) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-4 ; 128) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-5 ; 129) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-6 ; 130) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-6 ; 131) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-7 ; 132) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 3747 ; 133) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 3916-1 ; 134) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 3916-3 ; 135) SBA73FFKW9, UDI-DI: 10197106535608(each), 50197106535606(case), Lot Number: 9243-1 ; 136) SBA95BMHH6, UDI-DI: 10197106912904(each), 50197106912902(case), Lot Number: 13673 ; 137) SBA95BMHH7, UDI-DI: 10198956018662(each), 50198956018660(case), Lot Number: 14813 ; 138) SBA95BMHH8, UDI-DI: 10198956083851(each), 50198956083859(case), Lot Number: 14813 ; 139) SBA95BMHHF, UDI-DI: 10197106333402(each), 50197106333400(case), Lot Number: 13289 ; 140) SBA95BMHHG, UDI-DI: 10197106890653(each), 50197106890651(case), Lot Number: 15192 ; 141) SBA95BMHHG, UDI-DI: 10197106890653(each), 50197106890651(case), Lot Number: 15192 ; 142) SBA95BMHHH, UDI-DI: 10198956208629(each), 50198956208627(case), Lot Number: 15192 ; 143) SBA95BMHHH, UDI-DI: 10198956208629(each), 50198956208627(case), Lot Number: 16409 ; 144) SBA95BMHHH, UDI-DI: 10198956208629(each), 50198956208627(case), Lot Number: 16409 ; 145) SBA95BMHHH, UDI-DI: 10198956208629(each), 50198956208627(case), Lot Number: 19316 ; 146) SBA95TPD10, UDI-DI: 10198956007864(each), 50198956007862(case), Lot Number: 11020 ; 147) SBA95TPD11, UDI-DI: 10198956269125(each), 50198956269123(case), Lot Number: 12206 ; 148) SBA95TPD11, UDI-DI: 10198956269125(each), 50198956269123(case), Lot Number: 15463 ; 149) SBA95TPDU6, UDI-DI: 10195594893613(each), 50195594893611(case), Lot Number: 3916 ; 150) SBA95TPDU7, UDI-DI: 10197106395165(each), 50197106395163(case), Lot Number: 4869-2 ; 151) SBA95TPDU8, UDI-DI: 10197106718797(each), 50197106718795(case), Lot Number: 10339 ; 152) SBA95TPDU9, UDI-DI: 10197106723401(each), 50197106723409(case), Lot Number: 10339 ; 153) SBA95TPDUP, UDI-DI: 10195594169121(each), 50195594169129(case), Lot Number: 3916 ; 154) SBA95TPDUP, UDI-DI: 10195594169121(each), 50195594169129(case), Lot Number: 4366 ; 155) SBA95TPDUP, UDI-DI: 10195594169121(each), 50195594169129(case), Lot Number: 4869-2 ; 156) SBA95TPDUP, UDI-DI: 10195594169121(each), 50195594169129(case), Lot Number: 3024 ; 157) SBA95TPDUP, UDI-DI: 10195594169121(each), 50195594169129(case), Lot Number: 3916 ; 158) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 4869-1 ; 159) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 8160 ; 160) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 8808-2 ; 161) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 10339 ; 162) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 10339 ; 163) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 10586 ; 164) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 10586 ; 165) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 10586 ; 166) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 10586 ; 167) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 10586 ; 168) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 11851 ; 169) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 12206 ; 170) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 12206 ; 171) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 12641 ; 172) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 12206 ; 173) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 12206 ; 174) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 12206 ; 175) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 12206 ; 176) SBA95TPDUQ, UDI-DI: 10197106481691(each), 50197106481699(case), Lot Number: 15463 ; 177) SBACGPLGP2, UDI-DI: 10195594719425(each), 50195594719423(case), Lot Number: 2390 ; 178) SBACGPLGPB, UDI-DI: 10888439061314(each), 50888439061312(case), Lot Number: 3024-2 ; 179) SBACGPLGPB, UDI-DI: 10888439061314(each), 50888439061312(case), Lot Number: 94970 ; 180) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 94970 ; 181) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 4366 ; 182) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 4869 ; 183) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 94547 ; 184) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 11020 ; 185) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 9243-1 ; 186) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 12206 ; 187) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 15192 ; 188) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 15192 ; 189) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 15463 ; 190) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 15192 ; 191) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 15463 ; 192) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 15463-1 ; 193) SBACGPLGPC, UDI-DI: 10197106023501(each), 50197106023509(case), Lot Number: 4366 ; 194) SBADHBPRCD, UDI-DI: 10195594118754(each), 50195594118752(case), Lot Number: 11790 ; 195) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 9243 ; 196) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 9243-1 ; 197) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 10339 ; 198) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 10392 ; 199) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 10586 ; 200) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 11851 ; 201) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 12206 ; 202) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 15192 ; 203) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 15192 ; 204) SBAHDRPWEA, UDI-DI: 10197106351970(each), 50197106351978(case), Lot Number: 15192 ; 205) SBAHDSFRV2, UDI-DI: 10197106964439(each), 50197106964437(case), Lot Number: 12641 ; 206) SBAMHMFBHS, UDI-DI: 10197106889657(each), 50197106889655(case), Lot Number: 12206 ; 207) SBAMISEGR1, UDI-DI: 10197106564219(each), 50197106564217(case), Lot Number: 8808-1 ; 208) SBAMISEGRA, UDI-DI: 10197106357163(each), 50197106357161(case), Lot Number: 4869-2 ; 209) SBAMISEGRA, UDI-DI: 10197106357163(each), 50197106357161(case), Lot Number: 4869-2 ; 210) SBAMISEGRA, UDI-DI: 10197106357163(each), 50197106357161(case), Lot Number: 7044 ; 211) SBAMISEGRA, UDI-DI: 10197106357163(each), 50197106357161(case), Lot Number: 4869-1 ; 212) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 8160 ; 213) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 8808-1 ; 214) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 8808-1 ; 215) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 8160 ; 216) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 10339 ; 217) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 10339 ; 218) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 10339 ; 219) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 10339 ; 220) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 10339 ; 221) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 10339 ; 222) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 9243-1 ; 223) SBAMISEGRB, UDI-DI: 10197106496008(each), 50197106496006(case), Lot Number: 10339 ; 224) SBAOCFFK19, UDI-DI: 10198956130609(each), 50198956130607(case), Lot Number: 15192 ; 225) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 13673 ; 226) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 13673 ; 227) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 13673 ; 228) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 13673 ; 229) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 14813 ; 230) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 14813-1 ; 231) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 15192 ; 232) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 15192 ; 233) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 15192 ; 234) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 15192 ; 235) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 15192 ; 236) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 15192 ; 237) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 15463-1 ; 238) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 15463-1 ; 239) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 15463-1 ; 240) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 16409 ; 241) SBAOCFFKEG, UDI-DI: 10197106891728(each), 50197106891726(case), Lot Number: 16409 ; 242) SBAOCFFKEH, UDI-DI: 10198956308077(each), 50198956308075(case), Lot Number: 16409 ; 243) SBAOCFFKEH, UDI-DI: 10198956308077(each), 50198956308075(case), Lot Number: 16409 ; 244) SBAOCFFKEH, UDI-DI: 10198956308077(each), 50198956308075(case), Lot Number: 19316 ; 245) SBAOCFFKEH, UDI-DI: 10198956308077(each), 50198956308075(case), Lot Number: 19316 ; 246) SBAOCFFKEH, UDI-DI: 10198956308077(each), 50198956308075(case), Lot Number: 19316 ; 247) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 14039 ; 248) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 14813 ; 249) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 14039 ; 250) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 15463 ; 251) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 15463-3 ; 252) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 15463-2 ; 253) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 15463-4 ; 254) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 15463 ; 255) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 15463-6 ; 256) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 14813 ; 257) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 15463-6 ; 258) SBAOR0604A, UDI-DI: 10198956004665(each), 50198956004663(case), Lot Number: 14039 ; 259) SCV30VAFHS, UDI-DI: 10195594450007(each), 50195594450005(case), Lot Number: 12206 ; 260) SEN11ETSBJ, UDI-DI: 10197106471111(each), 50197106471119(case), Lot Number: 12206 ; 261) SEN11NASPC, UDI-DI: 10195594595012(each), 50195594595010(case), Lot Number: 11020-1 ; 262) SEN11NASPD, UDI-DI: 10197106887684(each), 50197106887682(case), Lot Number: 12206 ; 263) SEN11NASPD, UDI-DI: 10197106887684(each), 50197106887682(case), Lot Number: 12206 ; 264) SEN11NSE14, UDI-DI: 10197106989654(each), 50197106989652(case), Lot Number: 14039 ; 265) SEN11SEUHC, UDI-DI: 10195594552718(each), 50195594552716(case), Lot Number: 12206 ; 266) SEN11SIS15, UDI-DI: 10197106930939(each), 50197106930937(case), Lot Number: 11851 ; 267) SEN11SIS16, UDI-DI: 10197106986875(each), 50197106986873(case), Lot Number: 14039 ; 268) SEN11SPHKK, UDI-DI: 10197106897584(each), 50197106897582(case), Lot Number: 11851 ; 269) SEN11SPHKK, UDI-DI: 10197106897584(each), 50197106897582(case), Lot Number: 14813 ; 270) SEN11SPJYI, UDI-DI: 10197106897652(each), 50197106897650(case), Lot Number: 14039 ; 271) SEN12BSFBW, UDI-DI: 10197106894378(each), 50197106894376(case), Lot Number: 12206 ; 272) SEN12BSFBW, UDI-DI: 10197106894378(each), 50197106894376(case), Lot Number: 12206 ; 273) SEN12NS761, UDI-DI: 10198956012516(each), 50198956012514(case), Lot Number: 14813 ; 274) SEN13EABTB, UDI-DI: 10197106853085(each), 50197106853083(case), Lot Number: 12206 ; 275) SEN13EABTB, UDI-DI: 10197106853085(each), 50197106853083(case), Lot Number: 12641 ; 276) SEN13ENNAO, UDI-DI: 10197106883242(each), 50197106883240(case), Lot Number: 12206 ; 277) SEN13ENNAO, UDI-DI: 10197106883242(each), 50197106883240(case), Lot Number: 12206 ; 278) SEN14BSRGT, UDI-DI: 10888439375930(each), 50888439375938(case), Lot Number: 94970 ; 279) SEN14BSRGT, UDI-DI: 10888439375930(each), 50888439375938(case), Lot Number: 94970 ; 280) SEN14BSRGT, UDI-DI: 10888439375930(each), 50888439375938(case), Lot Number: 94970 ; 281) SEN14BSRGT, UDI-DI: 10888439375930(each), 50888439375938(case), Lot Number: 3024 ; 282) SEN15NSFSP, UDI-DI: 10197106910443(each), 50197106910441(case), Lot Number: 12206 ; 283) SEN16BSVSO, UDI-DI: 10197106822890(each), 50197106822898(case), Lot Number: 11851 ; 284) SEN16BSVSO, UDI-DI: 10197106822890(each), 50197106822898(case), Lot Number: 12641 ; 285) SEN1DNSUNK, UDI-DI: 10197106897669(each), 50197106897667(case), Lot Number: 11851 ; 286) SEN1DNSUNL, UDI-DI: 10197106926932(each), 50197106926930(case), Lot Number: 12206 ; 287) SEN21EN616, UDI-DI: 10197106987308(each), 50197106987306(case), Lot Number: 14039 ; 288) SEN21EN62F, UDI-DI: 10197106907337(each), 50197106907335(case), Lot Number: 12641 ; 289) SEN21EN62F, UDI-DI: 10197106907337(each), 50197106907335(case), Lot Number: 12641 ; 290) SEN21EN62F, UDI-DI: 10197106907337(each), 50197106907335(case), Lot Number: 15192 ; 291) SEN21EN62F, UDI-DI: 10197106907337(each), 501971
Quantity: 36862 kits
Distribution: US Nationwide. Canada.
Recalling firm: Cardinal Health 200, LLC, Waukegan, IL
Voluntary or mandated: Voluntary: Firm initiated
Recall started: 2026-07-14

Source: openFDA enforcement record Z-2942-2026 · search recall number Z-2942-2026 in FDA's Enforcement Report.

Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.