← FDA ENFORCEMENT
Z-2948-2026Class II

Cardinal Health 200, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Cardinal Health 200, LLC
Product type
Device
Status
Ongoing
Report date
2026-08-19
Distribution
US Nationwide. Canada.
Firm state
IL
Product quantity
52699 kits
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH4; 3) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCH5; 4) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 5) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLA9; 6) KIT, ANT CERVICAL DISC , Catalog Number: PN41ACLAI; 7) KIT, LAMINECTOMY , Catalog Number: PN41LMB10; 8) KIT, LAMINECTOMY , Catalog Number: PN41LMB11; 9) KIT, LAMINECTOMY , Catalog Number: PN41LMB12; 10) KIT, NEURO LAMINECTOMY , Catalog Number: PN41LMBLC; 11) KIT, BAL CRANIOTOMY , Catalog Number: PNCGCRBMF; 12) KIT,LAMINECTOMY NH , Catalog Number: PNOCLNNHB; 13) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA235; 14) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA236; 15) KIT, NEURO LAMINECTOMY , Catalog Number: PNVMOTA237; 63

Code / lot info

1) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 2) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15463-6 ; 3) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 4) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14039 ; 5) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 14813 ; 6) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 7) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 8) PN33NBMYD, UDI-DI: 10198956187474(each), 50198956187472(case), Lot Number: 15192 ; 9) PN36NBCH4, UDI-DI: 10198956129863(each), 50198956129861(case), Lot Number: 14813 ; 10) PN36NBCH5, UDI-DI: 10198956131538(each), 50198956131536(case), Lot Number: 14813 ; 11) PN41ACLA9, UDI-DI: 10197106346105(each), 50197106346103(case), Lot Number: 4869 ; 12) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 13) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 4366 ; 14) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 15) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 1726-1 ; 16) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3024 ; 17) PN41ACLAH, UDI-DI: 10195594177300(each), 50195594177308(case), Lot Number: 3916-1 ; 18) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 7748 ; 19) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8160 ; 20) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8160 ; 21) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8808-2 ; 22) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 8808-2 ; 23) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243 ; 24) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243-1 ; 25) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 9243-1 ; 26) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 11020 ; 27) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12206 ; 28) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12206 ; 29) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 12641 ; 30) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13289 ; 31) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 32) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 33) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 13673 ; 34) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 14813 ; 35) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 15192 ; 36) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 15192 ; 37) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 16409 ; 38) PN41ACLAI, UDI-DI: 10197106320815(each), 50197106320813(case), Lot Number: 16409 ; 39) PN41LMB10, UDI-DI: 10197106987032(each), 50197106987030(case), Lot Number: 14039 ; 40) PN41LMB11, UDI-DI: 10198956028685(each), 50198956028683(case), Lot Number: 14039 ; 41) PN41LMB12, UDI-DI: 10198956062870(each), 50198956062878(case), Lot Number: 14039 ; 42) PN41LMBLC, UDI-DI: 10888439949698(each), 50888439949696(case), Lot Number: 93845 ; 43) PNCGCRBMF, UDI-DI: 10197106169964(each), 50197106169962(case), Lot Number: 12206 ; 44) PNCGCRBMF, UDI-DI: 10197106169964(each), 50197106169962(case), Lot Number: 3916-2 ; 45) PNCGCRBMF, UDI-DI: 10197106169964(each), 50197106169962(case), Lot Number: 7748-2 ; 46) PNOCLNNHB, UDI-DI: 10198956072039(each), 50198956072037(case), Lot Number: 15463-1 ; 47) PNOCLNNHB, UDI-DI: 10198956072039(each), 50198956072037(case), Lot Number: 15463-2 ; 48) PNVMOTA235, UDI-DI: 10198956136502(each), 50198956136500(case), Lot Number: 15192 ; 49) PNVMOTA236, UDI-DI: 10198956138087(each), 50198956138085(case), Lot Number: 14813-1 ; 50) PNVMOTA236, UDI-DI: 10198956138087(each), 50198956138085(case), Lot Number: 15192 ; 51) PNVMOTA237, UDI-DI: 10198956143494(each), 50198956143492(case), Lot Number: 15192 ; 52) PNVMOTA238, UDI-DI: 10198956166189(each), 50198956166187(case), Lot Number: 15192 ; 53) PNVMOTA239, UDI-DI: 10198956170780(each), 50198956170788(case), Lot Number: 15192 ; 54) PNVMOTA240, UDI-DI: 10198956183049(each), 50198956183047(case), Lot Number: 15463 ; 55) PNVMOTA241, UDI-DI: 10198956189867(each), 50198956189865(case), Lot Number: 15463 ; 56) PNVMTR22S, UDI-DI: 10198956160682(each), 50198956160680(case), Lot Number: 15192 ; 57) PNVMTR22S, UDI-DI: 10198956160682(each), 50198956160680(case), Lot Number: 16409 ; 58) PNVMTR22S, UDI-DI: 10198956160682(each), 50198956160680(case), Lot Number: 16409 ; 59) PNVMTR240, UDI-DI: 10198956034976(each), 50198956034974(case), Lot Number: 14813 ; 60) PNVMTR241, UDI-DI: 10198956259928(each), 50198956259926(case), Lot Number: 15463-1 ; 61) PNVMTR242, UDI-DI: 10198956268081(each), 50198956268089(case), Lot Number: 15463-2 ; 62) PNVNCR90S, UDI-DI: 10198956448209(each), 50198956448207(case), Lot Number: 15463 ; 63) PNVNCR920, UDI-DI: 10198956468863(each), 50198956468861(case), Lot Number: 15463 ; 64) PNVPCY018, UDI-DI: 10197106965320(each), 50197106965328(case), Lot Number: 12641 ; 65) PNVPCY019, UDI-DI: 10198956028463(each), 50198956028461(case), Lot Number: 14813 ; 66) PNVPLM020, UDI-DI: 10197106987223(each), 50197106987221(case), Lot Number: 14039 ; 67) PNVQ46002, UDI-DI: 10197106954096(each), 50197106954094(case), Lot Number: 12206 ; 68) PNVQ46003, UDI-DI: 10197106979068(each), 50197106979066(case), Lot Number: 12641 ; 69) PNVQCY035, UDI-DI: 10197106863190(each), 50197106863198(case), Lot Number: 9243 ; 70) PNVXCR60A, UDI-DI: 10197106908983(each), 50197106908981(case), Lot Number: 12206 ; 71) PNVXCRL23, UDI-DI: 10197106858974(each), 50197106858972(case), Lot Number: 11020 ; 72) PNVXLMBM1, UDI-DI: 10195594740252(each), 50195594740250(case), Lot Number: 3024 ; 73) PNVXLMBM1, UDI-DI: 10195594740252(each), 50195594740250(case), Lot Number: 3024 ; 74) PNVXLMBM2, UDI-DI: 10198956020832(each), 50198956020830(case), Lot Number: 14039 ; 75) PNVXLMBM2, UDI-DI: 10198956020832(each), 50198956020830(case), Lot Number: 14039 ; 76) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 7044 ; 77) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 4869-1 ; 78) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 9243 ; 79) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 9243-2 ; 80) PNVXLMBMA, UDI-DI: 11020 (each), 10195594143251(case), Lot Number: 50195594143259; 81) PNVXLMBMA, UDI-DI: 11020 (each), 10195594143251(case), Lot Number: 50195594143259; 82) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 2390 ; 83) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 2390 ; 84) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 93845 ; 85) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: W0M57147 ; 86) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 3024 ; 87) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 4730 ; 88) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 4730 ; 89) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 6033 ; 90) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 7044 ; 91) PNVXLMBMA, UDI-DI: 10195594143251(each), 50195594143259(case), Lot Number: 9243 ; 92) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 10339 ; 93) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 10392 ; 94) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 10586 ; 95) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 11851 ; 96) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 12206 ; 97) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 9243-1 ; 98) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 11851 ; 99) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 12641 ; 100) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 12641 ; 101) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 14039 ; 102) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 12641 ; 103) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 12641 ; 104) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 14039 ; 105) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 14039 ; 106) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 14039 ; 107) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 14813 ; 108) PO33OSMNB, UDI-DI: 10197106375181(each), 50197106375189(case), Lot Number: 15192 ; 109) PO33OSMNC, UDI-DI: 10198956186125(each), 50198956186123(case), Lot Number: 15192 ; 110) PO33OSMNC, UDI-DI: 10198956186125(each), 50198956186123(case), Lot Number: 14039 ; 111) PO33OSMNC, UDI-DI: 10198956186125(each), 50198956186123(case), Lot Number: 15192 ; 112) PO33OSMNC, UDI-DI: 10198956186125(each), 50198956186123(case), Lot Number: 15192 ; 113) PO33OSMNC, UDI-DI: 10198956186125(each), 50198956186123(case), Lot Number: 15192 ; 114) PO33OSMNC, UDI-DI: 10198956186125(each), 50198956186123(case), Lot Number: 15192 ; 115) PO33OSMNC, UDI-DI: 10198956186125(each), 50198956186123(case), Lot Number: 15192 ; 116) PO33OSMNC, UDI-DI: 10198956186125(each), 50198956186123(case), Lot Number: 15463 ; 117) PO37LMM10, UDI-DI: 10197106233290(each), 50197106233298(case), Lot Number: 4730 ; 118) PO37LMM10, UDI-DI: 10197106233290(each), 50197106233298(case), Lot Number: 4366 ; 119) PO37LMM11, UDI-DI: 10197106682302(each), 50197106682300(case), Lot Number: 10392 ; 120) PO37LMM11, UDI-DI: 10197106682302(each), 50197106682300(case), Lot Number: 10339 ; 121) PO37LMM12, UDI-DI: 10197106912331(each), 50197106912339(case), Lot Number: 13289 ; 122) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 13673 ; 123) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 14039 ; 124) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 14813 ; 125) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 14813 ; 126) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 14813 ; 127) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 10392 ; 128) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 10586 ; 129) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 9243-1 ; 130) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 14039 ; 131) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 14039 ; 132) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 12641 ; 133) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 14039 ; 134) PO4FOSWFB, UDI-DI: 10197106728284(each), 50197106728282(case), Lot Number: 14039 ; 135) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 14039 ; 136) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 14039 ; 137) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 14813 ; 138) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15192-1 ; 139) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15192-1 ; 140) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15463 ; 141) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15463 ; 142) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15463 ; 143) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15463-3 ; 144) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15463-4 ; 145) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15463 ; 146) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 11851 ; 147) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 14039 ; 148) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 11851 ; 149) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 14039 ; 150) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 14039 ; 151) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15192 ; 152) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 14039 ; 153) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15192 ; 154) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 14039 ; 155) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15192 ; 156) PO4FWOWFA, UDI-DI: 10198956025738(each), 50198956025736(case), Lot Number: 15192 ; 157) PO4FWOWFB, UDI-DI: 10198956291744(each), 50198956291742(case), Lot Number: 15463-5 ; 158) PO4FWOWFB, UDI-DI: 10198956291744(each), 50198956291742(case), Lot Number: 14039 ; 159) PO4FWOWFB, UDI-DI: 10198956291744(each), 50198956291742(case), Lot Number: 15192 ; 160) PO69SPG27, UDI-DI: 10197106893852(each), 50197106893850(case), Lot Number: 14039 ; 161) POCGOCCPC, UDI-DI: 10198956083875(each), 50198956083873(case), Lot Number: 15192 ; 162) POCGOCCPC, UDI-DI: 10198956083875(each), 50198956083873(case), Lot Number: 15192 ; 163) POCGOCCPC, UDI-DI: 10198956083875(each), 50198956083873(case), Lot Number: 15192 ; 164) POCGPSAUM, UDI-DI: 10197106437940(each), 50197106437948(case), Lot Number: 12206 ; 165) POCGPSAUM, UDI-DI: 10197106437940(each), 50197106437948(case), Lot Number: 13673 ; 166) POV2ASN16, UDI-DI: 10195594757809(each), 50195594757807(case), Lot Number: 3024-1 ; 167) POV2ASN17, UDI-DI: 10197106265208(each), 50197106265206(case), Lot Number: 4366 ; 168) POV2ASN18, UDI-DI: 10197106363225(each), 50197106363223(case), Lot Number: 4730 ; 169) POV2ASN19, UDI-DI: 10197106402887(each), 50197106402885(case), Lot Number: 4730 ; 170) POV2ASN20, UDI-DI: 10197106586747(each), 50197106586745(case), Lot Number: 8808-3 ; 171) POV2ASN21, UDI-DI: 10198956080195(each), 50198956080193(case), Lot Number: 11851 ; 172) POV2ASN22, UDI-DI: 10198956368187(each), 50198956368185(case), Lot Number: 15192 ; 173) POV2ASN23, UDI-DI: 10198956376915(each), 50198956376913(case), Lot Number: 15192 ; 174) POV2ASN24, UDI-DI: 10198956413511(each), 50198956413519(case), Lot Number: 15192 ; 175) POV2ASN25, UDI-DI: 10198956490215(each), 50198956490213(case), Lot Number: 15463 ; 176) POV2ASNUI, UDI-DI: 10195594176341(each), 50195594176349(case), Lot Number: 3916-1 ; 177) POV2ASNUI, UDI-DI: 10195594176341(each), 50195594176349(case), Lot Number: 4366 ; 178) POV2ASNUI, UDI-DI: 10195594176341(each), 50195594176349(case), Lot Number: 2390 ; 179) POV2ASNUI, UDI-DI: 10195594176341(each), 50195594176349(case), Lot Number: 3024-1 ; 180) POV2ASNUI, UDI-DI: 10195594176341(each), 50195594176349(case), Lot Number: 3916-2 ; 181) POV2ASNUI, UDI-DI: 10195594176341(each), 50195594176349(case), Lot Number: 3916-2 ; 182) POV2ASNUI, UDI-DI: 10195594176341(each), 50195594176349(case), Lot Number: 3916-2 ; 183) POV2ASNUI, UDI-DI: 10195594176341(each), 50195594176349(case), Lot Number: 3916-1 ; 184) POV2ASNUJ, UDI-DI: 10197106427026(each), 50197106427024(case), Lot Number: 3747 ; 185) POV2ASNUJ, UDI-DI: 10197106427026(each), 50197106427024(case), Lot Number: 8160 ; 186) POV2ASNUJ, UDI-DI: 10197106427026(each), 50197106427024(case), Lot Number: 8808-3 ; 187) POV2ASNUJ, UDI-DI: 10197106427026(each), 50197106427024(case), Lot Number: 9243 ; 188) POV2ASNUK, UDI-DI: 10197106589717(each), 50197106589715(case), Lot Number: 9243-1 ; 189) POV2ASNUK, UDI-DI: 10197106589717(each), 50197106589715(case), Lot Number: 9243-1 ; 190) POV2ASNUK, UDI-DI: 10197106589717(each), 50197106589715(case), Lot Number: 8160 ; 191) POV2ASNUK, UDI-DI: 10197106589717(each), 50197106589715(case), Lot Number: 10392 ; 192) POV2ASNUK, UDI-DI: 10197106589717(each), 50197106589715(case), Lot Number: 10392 ; 193) POV2ASNUK, UDI-DI: 10197106589717(each), 50197106589715(case), Lot Number: 11851 ; 194) POV2ASNUK, UDI-DI: 10197106589717(each), 50197106589715(case), Lot Number: 9243-1 ; 195) POV2ASNUK, UDI-DI: 10197106589717(each), 50197106589715(case), Lot Number: 12641 ; 196) POVMDBB19, UDI-DI: 10197106987780(each), 50197106987788(case), Lot Number: 13673 ; 197) POVMDBB21, UDI-DI: 10198956048782(each), 50198956048780(case), Lot Number: 14813 ; 198) POVMDBB22, UDI-DI: 10198956069039(each), 50198956069037(case), Lot Number: 14813 ; 199) POVMDBB23, UDI-DI: 10198956088122(each), 50198956088120(case), Lot Number: 14813-1 ; 200) POVMDBB24, UDI-DI: 10198956150065(each), 50198956150063(case), Lot Number: 15192 ; 201) POVMDBBWG, UDI-DI: 10197106896976(each), 50197106896974(case), Lot Number: 14813 ; 202) POVMDBBWG, UDI-DI: 10197106896976(each), 50197106896974(case), Lot Number: 14813-1 ; 203) POVMDBBWG, UDI-DI: 10197106896976(each), 50197106896974(case), Lot Number: 14813-1 ; 204) POVMDBBWH, UDI-DI: 10198956168794(each), 50198956168792(case), Lot Number: 16409 ; 205) POVMDBBWH, UDI-DI: 10198956168794(each), 50198956168792(case), Lot Number: 16409 ; 206) POVMDBBWH, UDI-DI: 10198956168794(each), 50198956168792(case), Lot Number: 16409 ; 207) POVMDBBWH, UDI-DI: 10198956168794(each), 50198956168792(case), Lot Number: 19316 ; 208) POVMDBBWH, UDI-DI: 10198956168794(each), 50198956168792(case), Lot Number: 19316 ; 209) POX4SIPR2, UDI-DI: 10197106858752(each), 50197106858750(case), Lot Number: 11020 ; 210) POX4SIPR4, UDI-DI: 10197106989364(each), 50197106989362(case), Lot Number: 14039 ; 211) POX4SIPRC, UDI-DI: 10197106894460(each), 50197106894468(case), Lot Number: 12206 ; 212) PW11CRC20, UDI-DI: 10197106952412(each), 50197106952410(case), Lot Number: 12206 ; 213) PW11CRC21, UDI-DI: 10197106985892(each), 50197106985890(case), Lot Number: 14039 ; 214) PW40HNJUE, UDI-DI: 10197106758601(each), 50197106758609(case), Lot Number: 9243-1 ; 215) PW69PBKK1, UDI-DI: 10198956026780(each), 50198956026788(case), Lot Number: 14039 ; 216) PW69PBKK2, UDI-DI: 10198956057364(each), 50198956057362(case), Lot Number: 14039 ; 217) PW69PBKK3, UDI-DI: 10198956150713(each), 50198956150711(case), Lot Number: 14813 ; 218) PW69PBKK4, UDI-DI: 10198956206618(each), 50198956206616(case), Lot Number: 15463 ; 219) PW69PBKK5, UDI-DI: 10198956356016(each), 50198956356014(case), Lot Number: 15463-6 ; 220) PW69PBKK6, UDI-DI: 10198956455337(each), 50198956455335(case), Lot Number: 15463-7 ; 221) PWHFHNAMHF, UDI-DI: 10197106935606(each), 50197106935604(case), Lot Number: 12206 ; 222) SANCGLFCOA, UDI-DI: 10195594560966(each), 50195594560964(case), Lot Number: 12641 ; 223) SANCGLFCOA, UDI-DI: 10195594560966(each), 50195594560964(case), Lot Number: 11020 ; 224) SBA11DPS25, UDI-DI: 10197106932445(each), 50197106932443(case), Lot Number: 11851 ; 225) SBA11PRHKJ, UDI-DI: 10197106897577(each), 50197106897575(case), Lot Number: 11851 ; 226) SBA13TCBT1, UDI-DI: 10197106930984(each), 50197106930982(case), Lot Number: 13673 ; 227) SBA13TCBT2, UDI-DI: 10197106935194(each), 50197106935192(case), Lot Number: 13673 ; 228) SBA13TCBT2, UDI-DI: 10197106935194(each), 50197106935192(case), Lot Number: 12206 ; 229) SBA13TCBT3, UDI-DI: 10198956165816(each), 50198956165814(case), Lot Number: 15192-1 ; 230) SBA13TCBT3, UDI-DI: 10198956165816(each), 50198956165814(case), Lot Number: 15192 ; 231) SBA13TCBTA, UDI-DI: 10197106778388(each), 50197106778386(case), Lot Number: 12641 ; 232) SBA13TCBTA, UDI-DI: 10197106778388(each), 50197106778386(case), Lot Number: 9243 ; 233) SBA13TCBTB, UDI-DI: 10197106853061(each), 50197106853069(case), Lot Number: 15463-5 ; 234) SBA13TCBTB, UDI-DI: 10197106853061(each), 50197106853069(case), Lot Number: 15463-5 ; 235) SBA13TCBTB, UDI-DI: 10197106853061(each), 50197106853069(case), Lot Number: 15463-1 ; 236) SBA13TCBTB, UDI-DI: 10197106853061(each), 50197106853069(case), Lot Number: 15463-1 ; 237) SBA13TCBTC, UDI-DI: 10198956427228(each), 50198956427226(case), Lot Number: 14039 ; 238) SBA21ESPWC, UDI-DI: 10887488969886(each), 50887488969884(case), Lot Number: 94970 ; 239) SBA21ESPWC, UDI-DI: 10887488969886(each), 50887488969884(case), Lot Number: 2390 ; 240) SBA21ESPWC, UDI-DI: 10887488969886(each), 50887488969884(case), Lot Number: 3024-2 ; 241) SBA21ESPWC, UDI-DI: 10887488969886(each), 50887488969884(case), Lot Number: 3024-2 ; 242) SBA21ESPWC, UDI-DI: 10887488969886(each), 50887488969884(case), Lot Number: 3747 ; 243) SBA21ESPWC, UDI-DI: 10887488969886(each), 50887488969884(case), Lot Number: 3747 ; 244) SBA21ESPWC, UDI-DI: 10887488969886(each), 50887488969884(case), Lot Number: 3916-2 ; 245) SBA21ESPWC, UDI-DI: 10887488969886(each), 50887488969884(case), Lot Number: 4366 ; 246) SBA23RPSC1, UDI-DI: 10198956306813(each), 50198956306811(case), Lot Number: 15192 ; 247) SBA23RPSCB, UDI-DI: 10198956317789(each), 50198956317787(case), Lot Number: 15192 ; 248) SBA23RPSCB, UDI-DI: 10198956317789(each), 50198956317787(case), Lot Number: 15192 ; 249) SBA23RPSCB, UDI-DI: 10198956317789(each), 50198956317787(case), Lot Number: 15192 ; 250) SBA23RPSCB, UDI-DI: 10198956317789(each), 50198956317787(case), Lot Number: 15192 ; 251) SBA30MFOCD, UDI-DI: 10197106288559(each), 50197106288557(case), Lot Number: 13673 ; 252) SBA30MFOCE, UDI-DI: 10197106917978(each), 50197106917976(case), Lot Number: 14039 ; 253) SBA30MFSBB, UDI-DI: 10197106275283(each), 50197106275281(case), Lot Number: 12206 ; 254) SBA30MFSBB, UDI-DI: 10197106275283(each), 50197106275281(case), Lot Number: 12206 ; 255) SBA30PLOH3, UDI-DI: 10197106181867(each), 50197106181865(case), Lot Number: 3916-1 ; 256) SBA30PLOH4, UDI-DI: 10198956474543(each), 50198956474541(case), Lot Number: 15192 ; 257) SBA30PLOHD, UDI-DI: 10195594639358(each), 50195594639356(case), Lot Number: 4366 ; 258) SBA30PLOHD, UDI-DI: 10195594639358(each), 50195594639356(case), Lot Number: 4869-1 ; 259) SBA30PLOHD, UDI-DI: 10195594639358(each), 50195594639356(case), Lot Number: 94970 ; 260) SBA30PLOHD, UDI-DI: 10195594639358(each), 50195594639356(case), Lot Number: 1726 ; 261) SBA30PLOHD, UDI-DI: 10195594639358(each), 50195594639356(case), Lot Number: 3916-1 ; 262) SBA30PLOHD, UDI-DI: 10195594639358(each), 50195594639356(case), Lot Number: 3916-2 ; 263) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 3916-2 ; 264) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 7748-2 ; 265) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 4366 ; 266) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 9243 ; 267) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 9243-1 ; 268) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 9243-2 ; 269) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 10392 ; 270) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 9243-2 ; 271) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 9243 ; 272) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 11020 ; 273) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 11790 ; 274) SBA30PLOHE, UDI-DI: 10197106455708(each), 50197106455706(case), Lot Number: 11020 ; 275) SBA30PLOHF, UDI-DI: 10197106927328(each), 50197106927326(case), Lot Number: 14039 ; 276) SBA30PLOHG, UDI-DI: 10198956052239(each), 50198956052237(case), Lot Number: 14813 ; 277) SBA30PLOHG, UDI-DI: 10198956052239(each), 50198956052237(case), Lot Number: 14813 ; 278) SBA30PLOHG, UDI-DI: 10198956052239(each), 50198956052237(case), Lot Number: 14813 ; 279) SBA30PLOHG, UDI-DI: 10198956052239(each), 50198956052237(case), Lot Number: 15192 ; 280) SBA30PLOHG, UDI-DI: 10198956052239(each), 50198956052237(case), Lot Number: 15192 ; 281) SBA30PLOHG, UDI-DI: 10198956052239(each), 50198956052237(case), Lot Number: 15192 ; 282) SBA30PLOHH, UDI-DI: 10198956399655(each), 50198956399653(case), Lot Number: 15192 ; 283) SBA30PLOHH, UDI-DI: 10198956399655(each), 50198956399653(case), Lot Number: 15192 ; 284) SBA30TRMCE, UDI-DI: 10888439873160(each), 50888439873168(case), Lot Number: 10586 ; 285) SBA30TROCF, UDI-DI: 10197106927335(each), 50197106927333(case), Lot Number: 11020 ; 286) SBA32LAJ10, UDI-DI: 10195594724108(each), 50195594724106(case), Lot Number: 3024 ; 287) SBA32LAJ11, UDI-DI: 10197106042229(each), 50197106042227(case), Lot Number: 3916-3 ; 288) SBA32LAJWU, UDI-DI: 10195594740009(each), 50195594740007(case), Lot Number: 3916-3 ; 289) SBA32LAJWU, UDI-DI: 10195594740009(each), 50195594740007(case), Lot Number: 3024 ; 290) SBA32LAJWU, UDI-DI: 10195594740009(each), 50195594740007(case), Lot Number: 93845 ; 291) SBA32LAJWU, UDI-DI: 10195594740009(each), 50195594740007(case), Lot Number: 3024 ; 292) SBA32LAJWU, UDI-DI: 101955947400

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →