medical MODERATE Updated 2026-08-19

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

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Recalled 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 ,

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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