RecallHawk
Class II Recall

Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS

Cardinal Health 200, LLC

Summary

The FDA issued a Class II for Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Numbe by Cardinal Health 200, LLC. Reason: Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels..

Details

Source

Device Recall

External ID

Z-2945-2026

Action Date

2026-08-19

Status

Ongoing

Category

device

Product Description

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;

Lot/Code Info: 1) 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),

Quantity Affected: 87182 kits

Reason for Recall

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

Distribution

US Nationwide. Canada.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-07-14

Company

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 160 device recalls issued in the same week, part of 376 device-related FDA actions this month.

Cardinal Health 200, LLC has 150 FDA actions in our database, including 149 recalls and 1 clearance.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Cardinal Health 200, LLC have FDA actions?

Cardinal Health 200, LLC has 150 FDA actions in our database, including 149 recalls and 1 device clearance.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2945-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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