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Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) ...

FDA Device Recall #Z-2942-2026 - Class II, July 14, 2026

Recall Summary

Recall Number Z-2942-2026
Classification Class II - Moderate risk
Date Initiated July 14, 2026
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health 200, LLC
Location Waukegan, IL
Product Type Devices
Quantity 36862 kits

Product Description

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.

Distribution Pattern

US Nationwide. Canada.

Lot / Code Information

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

Other Recalls from Cardinal Health 200, LLC

Recall # Classification Product Date
Z-2949-2026 Class II Cardinal Health Presource Kits: 1) BASIC PACK ... Jul 14, 2026
Z-2944-2026 Class II Cardinal Health Presource Kits: 1) NEWNAN SMR ... Jul 14, 2026
Z-2945-2026 Class II Cardinal Health Presource Kits: 1) ENT TRAY ... Jul 14, 2026
Z-2948-2026 Class II Cardinal Health Presource Kits: 1) KIT, MER NE... Jul 14, 2026
Z-2943-2026 Class II Cardinal Health Presource Kits: 1) HARMONIZED ... Jul 14, 2026

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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