FDA Medical Device · Z-2945-2026

Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;

Class II · Ongoing

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

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Affected lots / codes — check yours against this1) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 2) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 3) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 4730 ; 4) 24-0726A, UDI-DI: 10195594855130(each), 50195594855138(case), Lot Number: 3747 ; 5) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 4366 ; 6) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 2390 ; 7) PE13SPAJA, UDI-DI: 10195594732189(each), 50195594732187(case), Lot Number: 265098 ; 8) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7390 ; 9) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 7575 ; 10) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 8160 ; 11) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 12) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 13) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 14) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 15) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 9243-1 ; 16) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 11020 ; 17) PE13SPAJB, UDI-DI: 10197106290910(each), 50197106290918(case), Lot Number: 10339 ; 18) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 19) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 20) PE13SPAJC, UDI-DI: 10198956124905(each), 50198956124903(case), Lot Number: 15463-2 ; 21) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8808-1 ; 22) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8808-2 ; 23) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 9243-1 ; 24) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10339 ; 25) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 8160 ; 26) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 11020 ; 27) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 28) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 29) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 10586 ; 30) PE29NSFGO, UDI-DI: 10197106544235(each), 50197106544233(case), Lot Number: 12206 ; 31) PE29NSFGP, UDI-DI: 10198956163379(each), 50198956163377(case), Lot Number: 12206 ; 32) PE29NSFGP, UDI-DI: 10198956163379(each), 50198956163377(case), Lot Number: 12206 ; 33) PE33HNCR1, UDI-DI: 10197106715765(each), 50197106715763(case), Lot Number: 10339 ; 34) PE33HNCR2, UDI-DI: 10197106973325(each), 50197106973323(case), Lot Number: 10586 ; 35) PE33HNCR3, UDI-DI: 10197106997628(each), 50197106997626(case), Lot Number: 11020 ; 36) PE33HNCR4, UDI-DI: 10198956051201(each), 50198956051209(case), Lot Number: 10586 ; 37) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 3916 ; 38) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 3916 ; 39) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4366 ; 40) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4730 ; 41) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4869-3 ; 42) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4869-2 ; 43) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 4869-1 ; 44) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 7044 ; 45) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 8160 ; 46) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 8160 ; 47) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 8808-2 ; 48) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 9243 ; 49) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 9243 ; 50) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 10339 ; 51) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 9243-1 ; 52) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 11020 ; 53) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 11020 ; 54) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 10586 ; 55) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 10586 ; 56) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 3916 ; 57) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 3916 ; 58) PE33HNCRA, UDI-DI: 10195594899226(each), 50195594899224(case), Lot Number: 3916 ; 59) PE33HNCRB, UDI-DI: 10197106904046(each), 50197106904044(case), Lot Number: 10586 ; 60) PE33HNCRB, UDI-DI: 10197106904046(each), 50197106904044(case), Lot Number: 12206 ; 61) PE33HNCRB, UDI-DI: 10197106904046(each), 50197106904044(case), Lot Number: 12206 ; 62) PE33HNCRB, UDI-DI: 10197106904046(each), 50197106904044(case), Lot Number: 12206 ; 63) PE33HNCRB, UDI-DI: 10197106904046(each), 50197106904044(case), Lot Number: 12206 ; 64) PE33HNCRB, UDI-DI: 10197106904046(each), 50197106904044(case), Lot Number: 12206 ; 65) PE33HNCRB, UDI-DI: 10197106904046(each), 50197106904044(case), Lot Number: 12206 ; 66) PE33HNCRB, UDI-DI: 10197106904046(each), 50197106904044(case), Lot Number: 15463 ; 67) PE33HNCRB, UDI-DI: 10197106904046(each), 50197106904044(case), Lot Number: 15463 ; 68) PE35NSB23, UDI-DI: 10197106970300(each), 50197106970308(case), Lot Number: 12641 ; 69) PE35NSBLG, UDI-DI: 10197106896747(each), 50197106896745(case), Lot Number: 12206 ; 70) PE44EMKW8, UDI-DI: 10195594886554(each), 50195594886552(case), Lot Number: 3747 ; 71) PE44EMKWG, UDI-DI: 10195594463182(each), 50195594463180(case), Lot Number: 3024-2 ; 72) PE44EMKWG, UDI-DI: 10195594463182(each), 50195594463180(case), Lot Number: 3024-2 ; 73) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 4366 ; 74) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 4730 ; 75) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 4366 ; 76) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 7748 ; 77) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 7784 ; 78) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 7784 ; 79) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 8808 ; 80) PE44EMKWH, UDI-DI: 8160 (each), 10195594789206(case), Lot Number: 50195594789204; 81) PE44EMKWH, UDI-DI: 9243 (each), 10195594789206(case), Lot Number: 50195594789204; 82) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 9243-1 ; 83) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 9243-1 ; 84) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 9243-1 ; 85) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 9243-1 ; 86) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 9243-1 ; 87) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 11020 ; 88) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 7784 ; 89) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 3916-1 ; 90) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 3916-2 ; 91) PE44EMKWH, UDI-DI: 10195594789206(each), 50195594789204(case), Lot Number: 3916-2 ; 92) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 9243 ; 93) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 12206 ; 94) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 12206 ; 95) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 14039 ; 96) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 12641 ; 97) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 15192 ; 98) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 15192 ; 99) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 15192 ; 100) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 15192 ; 101) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 15192 ; 102) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 15463 ; 103) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 15463 ; 104) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 15463-2 ; 105) PE44EMKWI, UDI-DI: 10197106815397(each), 50197106815395(case), Lot Number: 15463-2 ; 106) PE44EMKWJ, UDI-DI: 10198956343863(each), 50198956343861(case), Lot Number: 15463-3 ; 107) PE44EMKWJ, UDI-DI: 10198956343863(each), 50198956343861(case), Lot Number: 15463-3 ; 108) PE4ANPWMA, UDI-DI: 10197106045428(each), 50197106045426(case), Lot Number: 4869 ; 109) PE4ANPWMA, UDI-DI: 10197106045428(each), 50197106045426(case), Lot Number: 3916-2 ; 110) PECGMLBOB, UDI-DI: 10197106067406(each), 50197106067404(case), Lot Number: 3916-2 ; 111) PECGNAAUJ, UDI-DI: 10197106894514(each), 50197106894512(case), Lot Number: 12206 ; 112) PECGNSBO1, UDI-DI: 10195594872380(each), 50195594872388(case), Lot Number: 3916 ; 113) PECGNSBOA, UDI-DI: 10888439219166(each), 50888439219164(case), Lot Number: 94970 ; 114) PECGNSBOA, UDI-DI: 10888439219166(each), 50888439219164(case), Lot Number: 94970 ; 115) PN08CPPC3, UDI-DI: 10197106934579(each), 50197106934577(case), Lot Number: 13673 ; 116) PN08CPPCA, UDI-DI: 10197106722909(each), 50197106722907(case), Lot Number: 11020 ; 117) PN08CPPCA, UDI-DI: 10197106722909(each), 50197106722907(case), Lot Number: 11020 ; 118) PN08CPPCB, UDI-DI: 10197106931295(each), 50197106931293(case), Lot Number: 15192-1 ; 119) PN08CPPCB, UDI-DI: 10197106931295(each), 50197106931293(case), Lot Number: 15463 ; 120) PN08CPPCB, UDI-DI: 10197106931295(each), 50197106931293(case), Lot Number: 15463-4 ; 121) PN08CPPCB, UDI-DI: 10197106931295(each), 50197106931293(case), Lot Number: 15463-6 ; 122) PN08CRG10, UDI-DI: 10197106037249(each), 50197106037247(case), Lot Number: 3916-1 ; 123) PN08CRG10, UDI-DI: 10197106037249(each), 50197106037247(case), Lot Number: 3916-2 ; 124) PN08CRG10, UDI-DI: 10197106037249(each), 50197106037247(case), Lot Number: 3747 ; 125) PN08CRG10, UDI-DI: 10197106037249(each), 50197106037247(case), Lot Number: 3916-1 ; 126) PN08CRG11, UDI-DI: 10197106161999(each), 50197106161997(case), Lot Number: 4730 ; 127) PN08CRG11, UDI-DI: 10197106161999(each), 50197106161997(case), Lot Number: 4366 ; 128) PN08CRG12, UDI-DI: 10197106172988(each), 50197106172986(case), Lot Number: 4730 ; 129) PN08CRG12, UDI-DI: 10197106172988(each), 50197106172986(case), Lot Number: 94970 ; 130) PN08CRG13, UDI-DI: 10197106220382(each), 50197106220380(case), Lot Number: 3916-3 ; 131) PN08CRG13, UDI-DI: 10197106220382(each), 50197106220380(case), Lot Number: 4366 ; 132) PN08CRG14, UDI-DI: 10197106315408(each), 50197106315406(case), Lot Number: 4869 ; 133) PN08CRG15, UDI-DI: 10197106465523(each), 50197106465521(case), Lot Number: 7784-1 ; 134) PN08CRG15, UDI-DI: 10197106465523(each), 50197106465521(case), Lot Number: 7748 ; 135) PN08CRG16, UDI-DI: 10197106579565(each), 50197106579563(case), Lot Number: 9243-2 ; 136) PN08CRG16, UDI-DI: 10197106579565(each), 50197106579563(case), Lot Number: 9243 ; 137) PN08CRG17, UDI-DI: 10198956011298(each), 50198956011296(case), Lot Number: 14039 ; 138) PN08CRG18, UDI-DI: 10198956100084(each), 50198956100082(case), Lot Number: 14813 ; 139) PN08CRG18, UDI-DI: 10198956100084(each), 50198956100082(case), Lot Number: 15192 ; 140) PN08CRG19, UDI-DI: 10198956259287(each), 50198956259285(case), Lot Number: 15463-4 ; 141) PN08CRG19, UDI-DI: 10198956259287(each), 50198956259285(case), Lot Number: 15463 ; 142) PN08CRG20, UDI-DI: 10198956399990(each), 50198956399998(case), Lot Number: 15463-6 ; 143) PN08CRG20, UDI-DI: 10198956399990(each), 50198956399998(case), Lot Number: 15463-1 ; 144) PN08CRG21, UDI-DI: 10198956400269(each), 50198956400267(case), Lot Number: 15463-6 ; 145) PN08CRG21, UDI-DI: 10198956400269(each), 50198956400267(case), Lot Number: 15463-1 ; 146) PN08CRG23, UDI-DI: 10198956454828(each), 50198956454826(case), Lot Number: 15463-7 ; 147) PN08CRG23, UDI-DI: 10198956454828(each), 50198956454826(case), Lot Number: 15463-3 ; 148) PN08CRGH8, UDI-DI: 10195594715403(each), 50195594715401(case), Lot Number: 2390 ; 149) PN08CRGH9, UDI-DI: 10195594889418(each), 50195594889416(case), Lot Number: 93845 ; 150) PN08CRGH9, UDI-DI: 10195594889418(each), 50195594889416(case), Lot Number: 3747 ; 151) PN08CRGHH, UDI-DI: 10195594257149(each), 50195594257147(case), Lot Number: 2390 ; 152) PN08CRGHH, UDI-DI: 10195594257149(each), 50195594257147(case), Lot Number: 3024 ; 153) PN08CRGHH, UDI-DI: 10195594257149(each), 50195594257147(case), Lot Number: 3747 ; 154) PN08CRGHH, UDI-DI: 10195594257149(each), 50195594257147(case), Lot Number: 2390 ; 155) PN08CRGHH, UDI-DI: 10195594257149(each), 50195594257147(case), Lot Number: 3024-2 ; 156) PN08CRGHH, UDI-DI: 10195594257149(each), 50195594257147(case), Lot Number: 3024-2 ; 157) PN08CRGHJ, UDI-DI: 10197106083857(each), 50197106083855(case), Lot Number: 7575 ; 158) PN08CRGHJ, UDI-DI: 10197106083857(each), 50197106083855(case), Lot Number: 3916-3 ; 159) PN08CRGHJ, UDI-DI: 10197106083857(each), 50197106083855(case), Lot Number: 7575 ; 160) PN08CRGHJ, UDI-DI: 10197106083857(each), 50197106083855(case), Lot Number: 3916-2 ; 161) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 8160-2 ; 162) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 9243-1 ; 163) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 9243-2 ; 164) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 9243-2 ; 165) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 7390-1 ; 166) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 9243 ; 167) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 9243 ; 168) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 9243-1 ; 169) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 9243 ; 170) PN08CRGHK, UDI-DI: 10197106504550(each), 50197106504558(case), Lot Number: 9243-1 ; 171) PN08CRGHL, UDI-DI: 10197106710135(each), 50197106710133(case), Lot Number: 11020 ; 172) PN08CRGHL, UDI-DI: 10197106710135(each), 50197106710133(case), Lot Number: 11020 ; 173) PN08CRGHL, UDI-DI: 10197106710135(each), 50197106710133(case), Lot Number: 11020 ; 174) PN08CRGHL, UDI-DI: 10197106710135(each), 50197106710133(case), Lot Number: 11020 ; 175) PN08CRGHM, UDI-DI: 10197106758939(each), 50197106758937(case), Lot Number: 12206 ; 176) PN08CRGHM, UDI-DI: 10197106758939(each), 50197106758937(case), Lot Number: 11020-1 ; 177) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 13673 ; 178) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 14039 ; 179) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 14039 ; 180) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 14813 ; 181) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 15463 ; 182) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 15463-3 ; 183) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 11851 ; 184) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 12206 ; 185) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 14813 ; 186) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 15192 ; 187) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 15192 ; 188) PN08CRGHO, UDI-DI: 10197106867150(each), 50197106867158(case), Lot Number: 15192 ; 189) PN08CRGHP, UDI-DI: 10198956266520(each), 50198956266528(case), Lot Number: 15463-6 ; 190) PN08CRGHP, UDI-DI: 10198956266520(each), 50198956266528(case), Lot Number: 15463-2 ; 191) PN11TRCH2, UDI-DI: 10197106195659(each), 50197106195657(case), Lot Number: 4730 ; 192) PN11TRCH2, UDI-DI: 10197106195659(each), 50197106195657(case), Lot Number: 4366 ; 193) PN11TRCH3, UDI-DI: 10197106341827(each), 50197106341825(case), Lot Number: 7390 ; 194) PN11TRCH3, UDI-DI: 10197106341827(each), 50197106341825(case), Lot Number: 4366 ; 195) PN11TRCH3, UDI-DI: 10197106341827(each), 50197106341825(case), Lot Number: 4869 ; 196) PN11TRCH4, UDI-DI: 10197106390245(each), 50197106390243(case), Lot Number: 7575 ; 197) PN11TRCH4, UDI-DI: 10197106390245(each), 50197106390243(case), Lot Number: 7390 ; 198) PN11TRCH5, UDI-DI: 10197106800362(each), 50197106800360(case), Lot Number: 11851 ; 199) PN11TRCH5, UDI-DI: 10197106800362(each), 50197106800360(case), Lot Number: 9243-1 ; 200) PN11TRCH6, UDI-DI: 10197106845639(each), 50197106845637(case), Lot Number: 11020 ; 201) PN11TRCH6, UDI-DI: 10197106845639(each), 50197106845637(case), Lot Number: 10586 ; 202) PN11TRCH7, UDI-DI: 10197106859193(each), 50197106859191(case), Lot Number: 11020 ; 203) PN11TRCH7, UDI-DI: 10197106859193(each), 50197106859191(case), Lot Number: 11020-1 ; 204) PN11TRCH8, UDI-DI: 10198956021556(each), 50198956021554(case), Lot Number: 14039 ; 205) PN11TRCH9, UDI-DI: 10198956078284(each), 50198956078282(case), Lot Number: 14813 ; 206) PN11TRCH9, UDI-DI: 10198956078284(each), 50198956078282(case), Lot Number: 12641 ; 207) PN11TRCHG, UDI-DI: 10195594673314(each), 50195594673312(case), Lot Number: 4730 ; 208) PN11TRCHG, UDI-DI: 10195594673314(each), 50195594673312(case), Lot Number: 93845 ; 209) PN11TRCHG, UDI-DI: 10195594673314(each), 50195594673312(case), Lot Number: 4366 ; 210) PN11TRCHI, UDI-DI: 10197106307519(each), 50197106307517(case), Lot Number: 11020 ; 211) PN11TRCHI, UDI-DI: 10197106307519(each), 50197106307517(case), Lot Number: 15463-7 ; 212) PN11TRCHI, UDI-DI: 10197106307519(each), 50197106307517(case), Lot Number: 11020 ; 213) PN11TRCHI, UDI-DI: 10197106307519(each), 50197106307517(case), Lot Number: 15463-3 ; 214) PN15SSFR9, UDI-DI: 10197106818633(each), 50197106818631(case), Lot Number: 11851 ; 215) PN1DTSL10, UDI-DI: 10198956146082(each), 50198956146080(case), Lot Number: 15192-1 ; 216) PN1DTSL10, UDI-DI: 10198956146082(each), 50198956146080(case), Lot Number: 14039 ; 217) PN1DTSL11, UDI-DI: 10198956148970(each), 50198956148978(case), Lot Number: 14813 ; 218) PN1DTSL11, UDI-DI: 10198956148970(each), 50198956148978(case), Lot Number: 14813 ; 219) PN1DTSL12, UDI-DI: 10198956180321(each), 50198956180329(case), Lot Number: 15463 ; 220) PN1DTSL12, UDI-DI: 10198956180321(each), 50198956180329(case), Lot Number: 15192 ; 221) PN1DTSL13, UDI-DI: 10198956184664(each), 50198956184662(case), Lot Number: 15463 ; 222) PN1DTSL13, UDI-DI: 10198956184664(each), 50198956184662(case), Lot Number: 15192 ; 223) PN1DTSL14, UDI-DI: 10198956194731(each), 50198956194739(case), Lot Number: 15463 ; 224) PN1DTSL14, UDI-DI: 10198956194731(each), 50198956194739(case), Lot Number: 15192 ; 225) PN1DTSLH1, UDI-DI: 10197106240120(each), 50197106240128(case), Lot Number: 3916-2 ; 226) PN1DTSLH1, UDI-DI: 10197106240120(each), 50197106240128(case), Lot Number: 4366-2 ; 227) PN1DTSLH1, UDI-DI: 10197106240120(each), 50197106240128(case), Lot Number: 4366 ; 228) PN1DTSLH2, UDI-DI: 10197106374290(each), 50197106374298(case), Lot Number: 4730 ; 229) PN1DTSLH3, UDI-DI: 10197106584958(each), 50197106584956(case), Lot Number: 9243-1 ; 230) PN1DTSLH3, UDI-DI: 10197106584958(each), 50197106584956(case), Lot Number: 8808-3 ; 231) PN1DTSLH4, UDI-DI: 10197106614020(each), 50197106614028(case), Lot Number: 9243-2 ; 232) PN1DTSLH5, UDI-DI: 10198956011373(each), 50198956011371(case), Lot Number: 14039 ; 233) PN1DTSLH5, UDI-DI: 10198956011373(each), 50198956011371(case), Lot Number: 12641 ; 234) PN1DTSLH6, UDI-DI: 10198956046153(each), 50198956046151(case), Lot Number: 14039 ; 235) PN1DTSLH6, UDI-DI: 10198956046153(each), 50198956046151(case), Lot Number: 14039 ; 236) PN1DTSLH7, UDI-DI: 10198956068797(each), 50198956068795(case), Lot Number: 14039 ; 237) PN1DTSLH7, UDI-DI: 10198956068797(each), 50198956068795(case), Lot Number: 14039 ; 238) PN1DTSLH8, UDI-DI: 10198956091986(each), 50198956091984(case), Lot Number: 14813 ; 239) PN1DTSLH8, UDI-DI: 10198956091986(each), 50198956091984(case), Lot Number: 12641 ; 240) SCV30VAFHS, UDI-DI: 10195594450007(each), 50195594450005(case), Lot Number: 12206 ; 241) SEN11ENCHS, UDI-DI: 10195594673352(each), 50195594673350(case), Lot Number: 12206 ; 242) SEN11ENCHS, UDI-DI: 10195594673352(each), 50195594673350(case), Lot Number: 12206 ; 243) SEN11NSE13, UDI-DI: 10197106986059(each), 50197106986057(case), Lot Number: 14039 ; 244) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 15463-2 ; 245) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 2390 ; 246) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 3916-1 ; 247) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 1103085 ; 248) SEN21SPPMB, UDI-DI: 10888439504965(each), 50888439504963(case), Lot Number: 3916-2 ; 249) SEN23BRDUV, UDI-DI: 10888439451405(each), 50888439451403(case), Lot Number: 9243-1 ; 250) SEN23BRDUV, UDI-DI: 10888439451405(each), 50888439451403(case), Lot Number: 9243-2 ; 251) SEN23EN110, UDI-DI: 10197106613788(each), 50197106613786(case), Lot Number: 8808-2 ; 252) SEN23EN111, UDI-DI: 10197106801147(each), 50197106801145(case), Lot Number: 9243-1 ; 253) SEN23EN112, UDI-DI: 10197106977286(each), 50197106977284(case), Lot Number: 10586 ; 254) SEN23EN113, UDI-DI: 10198956011380(each), 50198956011388(case), Lot Number: 11020 ; 255) SEN23EN146, UDI-DI: 10195594806644(each), 50195594806642(case), Lot Number: 3747 ; 256) SEN23EN147, UDI-DI: 10197106184127(each), 50197106184125(case), Lot Number: 3916 ; 257) SEN23EN148, UDI-DI: 10197106425404(each), 50197106425402(case), Lot Number: 4869-2 ; 258) SEN23EN149, UDI-DI: 10197106464830(each), 50197106464838(case), Lot Number: 4869-1 ; 259) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 3916 ; 260) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 4730 ; 261) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 8160 ; 262) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 9243-1 ; 263) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 11020 ; 264) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 10586 ; 265) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 10586 ; 266) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 10586 ; 267) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 11020 ; 268) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 12206 ; 269) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 12206 ; 270) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 15463 ; 271) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 12206 ; 272) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 94970 ; 273) SEN23EN14T, UDI-DI: 10888439235890(each), 50888439235898(case), Lot Number: 3916 ; 274) SEN23ENVDY, UDI-DI: 10197106584576(each), 50197106584574(case), Lot Number: 11851 ; 275) SEN23ENVDY, UDI-DI: 10197106584576(each), 50197106584574(case), Lot Number: 12206 ; 276) SEN23NPCAA, UDI-DI: 10197106455142(each), 50197106455140(case), Lot Number: 7748 ; 277) SEN23NPCAA, UDI-DI: 10197106455142(each), 50197106455140(case), Lot Number: 9243 ; 278) SEN23NPCAA, UDI-DI: 10197106455142(each), 50197106455140(case), Lot Number: 9243 ; 279) SEN23NPCAA, UDI-DI: 10197106455142(each), 50197106455140(case), Lot Number: 9243-1 ; 280) SEN23NPCAA, UDI-DI: 10197106455142(each), 50197106455140(case), Lot Number: 9243-1 ; 281) SEN23NPCAA, UDI-DI: 10197106455142(each), 50197106455140(case), Lot Number: 9243-1 ; 282) SEN23NPCAA, UDI-DI: 10197106455142(each), 50197106455140(case), Lot Number: 9243-1 ; 283) SEN23NPCAA, UDI-DI: 10197106455142(each), 50197106455140(case), Lot Number: 10339 ; 284) SEN23NPCAB, UDI-DI: 10197106685426(each), 50197106685424(case), Lot Number: 11020 ; 285) SEN23NPCAB, UDI-DI: 10197106685426(each), 50197106685424(case), Lot Number: 11020 ; 286) SEN23NPCAB, UDI-DI: 10197106685426(each), 50197106685424(case), Lot Number: 9243 ; 287) SEN23NPCAB, UDI-DI: 10197106685426(each), 50197106685424(case), Lot Number: 12206 ; 288) SEN23NPCAB, UDI-DI: 10197106685426(each), 50197106685424(case), Lot Number: 15192 ; 289) SEN23NPCAB, UDI-DI: 10197106685426(each), 50197106685424(case), Lot Number: 15192 ; 290) SEN23NPCAB, UDI-DI: 10197106685426(each), 50197106685424(case), Lot Number: 15463-1 ; 291) SEN23NPCAB, UDI-DI: 10197106685426(each), 50197106685424(case), Lot Number: 15463-1 ; 292) SEN23NPCAB, UDI-DI: 10197106685426(each), 50197106685424(case),
Recalling firm
Cardinal Health 200, LLC, Waukegan, IL
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
87182 kits
Distribution
US Nationwide. Canada.
Recall initiated
July 14, 2026
Classified
August 13, 2026
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2945-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →