Recall archive / FDA device enforcement

Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number ... — FDA record Z-0908-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT912; 6) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT913; 7) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT914; 8) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT951; 9) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT952; 10) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT953; 11) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT954; 12) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT955; 13) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT956; 14) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT957; 15) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT958; 16) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT959; 17) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95A; 18) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95C; 19) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95F; 20) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT95G; 21) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV1; 22) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGV2; 23) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVB; 24) KIT,SMR RHINOPLASTY,Catalog Number PWOCRHGVC; 25) MAXILLO FACIAL PACK,Catalog Number SBA11CMCPD; 26) DIEP PACK,Catalog Number SBA11DPS10; 27) DIEP PACK,Catalog Number SBA11DPS11; 28) DIEP PACK,Catalog Number SBA11DPS12; 29) DIEP PACK,Catalog Number SBA11DPS13; 30) DIEP PACK,Catalog Number SBA11DPS14; 31) DIEP PACK,Catalog Number SBA11DPS15; 32) DIEP PACK,Catalog Number SBA11DPS16; 33) DIEP PACK,Catalog Number SBA11DPS17; 34) DIEP PACK,Catalog Number SBA11DPS18; 35) DIEP PACK,Catalog Number SBA11DPS19; 36) DIEP PACK,Catalog Number SBA11DPS20; 37) DIEP PACK,Catalog Number SBA11DPS21; 38) DIEP PACK,Catalog Number SBA11DPS22; 39) DIEP PACK,Catalog Number SBA11DPSB4; 40) DIEP PACK,Catalog Number SBA11DPSB5; 41) DIEP PACK,Catalog Number SBA11DPSB6; 42) DIEP PACK,Catalog Number SBA11DPSB7; 43) DIEP PACK,Catalog Number SBA11DPSB8; 44) DIEP PACK,Catalog Number SBA11DPSB9; 45) DIEP PACK,Catalog Number SBA11DPSBD; 46) DIEP PACK,Catalog Number SBA11DPSBE; 47) DIEP PACK,Catalog Number SBA11DPSBF; 48) DIEP PACK,Catalog Number SBA11DPSBG; 49) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP1; 50) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP2; 51) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP3; 52) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP4; 53) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP5; 54) MAXILLO FACIAL PACK,Catalog Number SBA11MXCP6; 55) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPB; 56) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPC; 57) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPD; 58) MAXILLO FACIAL PACK,Catalog Number SBA11MXCPE; 59) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH10; 60) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH11; 61) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH12; 62) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRH13; 63) PLASTIC RECONS...
Reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Classification: Class II
Recalling firm: Cardinal Health 200, LLC
Quantity: 512,786 total units
Agency-reported status: Ongoing
Source record identifier: Z-0908-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Catalog Number PGHDOT951, UDI/DI 10888439692228 (EA)50888439692226 (CS), Lot Number J4952D ; Catalog Number PGHDOT952, UDI/DI 10888439821260 (EA)50888439821268 (CS), Lot Number J6050F ; Catalog Number PWHDOT910, UDI/DI 10197106435052 (EA)50197106435050 (CS), Lot Number 6788561 ; Catalog Number PWHDOT911, UDI/DI 10197106646724 (EA)50197106646722 (CS), Lot Number 7332903 ; Catalog Number PWHDOT912, UDI/DI 10197106673195 (EA)50197106673193 (CS), Lot Number 7163082 ; Catalog Number PWHDOT913, UDI/DI 10197106713365 (EA)50197106713363 (CS), Lot Number 7332912 ; Catalog Number PWHDOT914, UDI/DI 10197106718834 (EA)50197106718832 (CS), Lot Number 7332914 ; Catalog Number PWHDOT951, UDI/DI 10888439940176 (EA)50888439940174 (CS), Lot Number J84K02 ; Catalog Number PWHDOT952, UDI/DI 10195594331474 (EA)50195594331472 (CS), Lot Number J6278U ; Catalog Number PWHDOT953, UDI/DI 10195594505493 (EA)50195594505491 (CS), Lot Number 5664102 ; Catalog Number PWHDOT954, UDI/DI 10195594555559 (EA)50195594555557 (CS), Lot Number 5664101 ; Catalog Number PWHDOT955, UDI/DI 10195594646134 (EA)50195594646132 (CS), Lot Number 5891310 ; Catalog Number PWHDOT956, UDI/DI 10195594697884 (EA)50195594697882 (CS), Lot Number 5891313 ; Catalog Number PWHDOT957, UDI/DI 10197106129982 (EA)50197106129980 (CS), Lot Number 6563987 ; Catalog Number PWHDOT958, UDI/DI 10197106188095 (EA)50197106188093 (CS), Lot Number 6563989 ; Catalog Number PWHDOT959, UDI/DI 10197106329771 (EA)50197106329779 (CS), Lot Number 6701853 ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671K ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671M ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671P ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number J86T83 ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number 5405627 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6487902 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6169297 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6264570 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6264565 ; Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number 6928765 ; Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number 7163033 ; Catalog Number PWOCRHGV1, UDI/DI 10197106262788 (EA)50197106262786 (CS), Lot Number 6701852 ; Catalog Number PWOCRHGV2, UDI/DI 10197106349755 (EA)50197106349753 (CS), Lot Number 6487903 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J53W72 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J5679F ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J6050F ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J84K04 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8124A ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8671N ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8123Y ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7332915 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 22174441 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6702009 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6596397 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928759 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6806115 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928764 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928773 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7163104 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7280111 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7287567 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7280109 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7163082 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7332904 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5140347 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5664101 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891309 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891308 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891310 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891312 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number J6367H ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891313 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6022128 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6025791 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6345522 ; Catalog Number SBA11CMCPD, UDI/DI 10888439548174 (EA)50888439548172 (CS), Lot Number J3464F ; Catalog Number SBA11DPS10, UDI/DI 10195594317010 (EA)50195594317018 (CS), Lot Number 5478803 ; Catalog Number SBA11DPS11, UDI/DI 10195594401580 (EA)50195594401588 (CS), Lot Number 5478803 ; Catalog Number SBA11DPS12, UDI/DI 10195594541651 (EA)50195594541659 (CS), Lot Number 5888374 ; Catalog Number SBA11DPS13, UDI/DI 10195594615192 (EA)50195594615190 (CS), Lot Number 5891311 ; Catalog Number SBA11DPS14, UDI/DI 10195594676995 (EA)50195594676993 (CS), Lot Number 5891305 ; Catalog Number SBA11DPS15, UDI/DI 10195594795788 (EA)50195594795786 (CS), Lot Number 6025787 ; Catalog Number SBA11DPS16, UDI/DI 10195594885267 (EA)50195594885265 (CS), Lot Number 5631069 ; Catalog Number SBA11DPS17, UDI/DI 10197106193761 (EA)50197106193769 (CS), Lot Number 6560944 ; Catalog Number SBA11DPS18, UDI/DI 10197106320099 (EA)50197106320097 (CS), Lot Number 6701853 ; Catalog Number SBA11DPS19, UDI/DI 10197106369456 (EA)50197106369454 (CS), Lot Number 6806113 ; Catalog Number SBA11DPS20, UDI/DI 10197106507544 (EA)50197106507542 (CS), Lot Number 6928764 ; Catalog Number SBA11DPS21, UDI/DI 10197106584798 (EA)50197106584796 (CS), Lot Number 7163104 ; Catalog Number SBA11DPS22, UDI/DI 10197106769782 (EA)50197106769780 (CS), Lot Number 7280108 ; Catalog Number SBA11DPSB4, UDI/DI 10888439689150 (EA)50888439689158 (CS), Lot Number J53W67 ; Catalog Number SBA11DPSB5, UDI/DI 10888439763836 (EA)50888439763834 (CS), Lot Number J53W73 ; Catalog Number SBA11DPSB6, UDI/DI 10888439995633 (EA)50888439995631 (CS), Lot Number J8671M ; Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number J9602T ; Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number 1933731664 ; Catalog Number SBA11DPSB8, UDI/DI 10195594075415 (EA)50195594075413 (CS), Lot Number 5135984 ; Catalog Number SBA11DPSB9, UDI/DI 10195594211462 (EA)50195594211460 (CS), Lot Number 5136018 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J34J43 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J46A99 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J70X20 ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8393U ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8123Y ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8671K ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8692Z ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6806114 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6928758 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5631072 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5891307 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5891310 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5631071 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 55693537 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264570 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264566 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264567 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6345523 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7280111 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7287567 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7332916 ; Catalog Number SBA11MXCP1, UDI/DI 10195594114985 (EA)50195594114983 (CS), Lot Number 5140342 ; Catalog Number SBA11MXCP2, UDI/DI 10195594347819 (EA)50195594347817 (CS), Lot Number 5478804 ; Catalog Number SBA11MXCP3, UDI/DI 10195594366544 (EA)50195594366542 (CS), Lot Number J6367F ; Catalog Number SBA11MXCP4, UDI/DI 10195594416027 (EA)50195594416025 (CS), Lot Number 5533336 ; Catalog Number SBA11MXCP5, UDI/DI 10195594756369 (EA)50195594756367 (CS), Lot Number 6022131 ; Catalog Number SBA11MXCP6, UDI/DI 10195594796587 (EA)50195594796585 (CS), Lot Number 6025787 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6563989 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number J86T81 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6025787 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6264570 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6345522 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487902 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487902 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487904 ; Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number 6487901 ; Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number 6596397 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6788562 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6928760 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6928760 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332917 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7163033 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7163103 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7280107 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332910 ; Catalog Number SBA...

Label field

Details supplied by the agency

Lot, code or applicability

Catalog Number PGHDOT951, UDI/DI 10888439692228 (EA)50888439692226 (CS), Lot Number J4952D ; Catalog Number PGHDOT952, UDI/DI 10888439821260 (EA)50888439821268 (CS), Lot Number J6050F ; Catalog Number PWHDOT910, UDI/DI 10197106435052 (EA)50197106435050 (CS), Lot Number 6788561 ; Catalog Number PWHDOT911, UDI/DI 10197106646724 (EA)50197106646722 (CS), Lot Number 7332903 ; Catalog Number PWHDOT912, UDI/DI 10197106673195 (EA)50197106673193 (CS), Lot Number 7163082 ; Catalog Number PWHDOT913, UDI/DI 10197106713365 (EA)50197106713363 (CS), Lot Number 7332912 ; Catalog Number PWHDOT914, UDI/DI 10197106718834 (EA)50197106718832 (CS), Lot Number 7332914 ; Catalog Number PWHDOT951, UDI/DI 10888439940176 (EA)50888439940174 (CS), Lot Number J84K02 ; Catalog Number PWHDOT952, UDI/DI 10195594331474 (EA)50195594331472 (CS), Lot Number J6278U ; Catalog Number PWHDOT953, UDI/DI 10195594505493 (EA)50195594505491 (CS), Lot Number 5664102 ; Catalog Number PWHDOT954, UDI/DI 10195594555559 (EA)50195594555557 (CS), Lot Number 5664101 ; Catalog Number PWHDOT955, UDI/DI 10195594646134 (EA)50195594646132 (CS), Lot Number 5891310 ; Catalog Number PWHDOT956, UDI/DI 10195594697884 (EA)50195594697882 (CS), Lot Number 5891313 ; Catalog Number PWHDOT957, UDI/DI 10197106129982 (EA)50197106129980 (CS), Lot Number 6563987 ; Catalog Number PWHDOT958, UDI/DI 10197106188095 (EA)50197106188093 (CS), Lot Number 6563989 ; Catalog Number PWHDOT959, UDI/DI 10197106329771 (EA)50197106329779 (CS), Lot Number 6701853 ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671K ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671M ; Catalog Number PWHDOT95A, UDI/DI 10888439749526 (EA)50888439749524 (CS), Lot Number J8671P ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number J86T83 ; Catalog Number PWHDOT95C, UDI/DI 10888439983265 (EA)50888439983263 (CS), Lot Number 5405627 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6487902 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6169297 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6264570 ; Catalog Number PWHDOT95F, UDI/DI 10195594714352 (EA)50195594714350 (CS), Lot Number 6264565 ; Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number 6928765 ; Catalog Number PWHDOT95G, UDI/DI 10197106473740 (EA)50197106473748 (CS), Lot Number 7163033 ; Catalog Number PWOCRHGV1, UDI/DI 10197106262788 (EA)50197106262786 (CS), Lot Number 6701852 ; Catalog Number PWOCRHGV2, UDI/DI 10197106349755 (EA)50197106349753 (CS), Lot Number 6487903 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J53W72 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J5679F ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J6050F ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J84K04 ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8124A ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8671N ; Catalog Number PWOCRHGVB, UDI/DI 10888439387469 (EA)50888439387467 (CS), Lot Number J8123Y ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7332915 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 22174441 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6702009 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6596397 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928759 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6806115 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928764 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6928773 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7163104 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7280111 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7287567 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7280109 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7163082 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 7332904 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5140347 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5664101 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891309 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891308 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891310 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891312 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number J6367H ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 5891313 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6022128 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6025791 ; Catalog Number PWOCRHGVC, UDI/DI 10195594926618 (EA)50195594926616 (CS), Lot Number 6345522 ; Catalog Number SBA11CMCPD, UDI/DI 10888439548174 (EA)50888439548172 (CS), Lot Number J3464F ; Catalog Number SBA11DPS10, UDI/DI 10195594317010 (EA)50195594317018 (CS), Lot Number 5478803 ; Catalog Number SBA11DPS11, UDI/DI 10195594401580 (EA)50195594401588 (CS), Lot Number 5478803 ; Catalog Number SBA11DPS12, UDI/DI 10195594541651 (EA)50195594541659 (CS), Lot Number 5888374 ; Catalog Number SBA11DPS13, UDI/DI 10195594615192 (EA)50195594615190 (CS), Lot Number 5891311 ; Catalog Number SBA11DPS14, UDI/DI 10195594676995 (EA)50195594676993 (CS), Lot Number 5891305 ; Catalog Number SBA11DPS15, UDI/DI 10195594795788 (EA)50195594795786 (CS), Lot Number 6025787 ; Catalog Number SBA11DPS16, UDI/DI 10195594885267 (EA)50195594885265 (CS), Lot Number 5631069 ; Catalog Number SBA11DPS17, UDI/DI 10197106193761 (EA)50197106193769 (CS), Lot Number 6560944 ; Catalog Number SBA11DPS18, UDI/DI 10197106320099 (EA)50197106320097 (CS), Lot Number 6701853 ; Catalog Number SBA11DPS19, UDI/DI 10197106369456 (EA)50197106369454 (CS), Lot Number 6806113 ; Catalog Number SBA11DPS20, UDI/DI 10197106507544 (EA)50197106507542 (CS), Lot Number 6928764 ; Catalog Number SBA11DPS21, UDI/DI 10197106584798 (EA)50197106584796 (CS), Lot Number 7163104 ; Catalog Number SBA11DPS22, UDI/DI 10197106769782 (EA)50197106769780 (CS), Lot Number 7280108 ; Catalog Number SBA11DPSB4, UDI/DI 10888439689150 (EA)50888439689158 (CS), Lot Number J53W67 ; Catalog Number SBA11DPSB5, UDI/DI 10888439763836 (EA)50888439763834 (CS), Lot Number J53W73 ; Catalog Number SBA11DPSB6, UDI/DI 10888439995633 (EA)50888439995631 (CS), Lot Number J8671M ; Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number J9602T ; Catalog Number SBA11DPSB7, UDI/DI 10195594022099 (EA)50195594022097 (CS), Lot Number 1933731664 ; Catalog Number SBA11DPSB8, UDI/DI 10195594075415 (EA)50195594075413 (CS), Lot Number 5135984 ; Catalog Number SBA11DPSB9, UDI/DI 10195594211462 (EA)50195594211460 (CS), Lot Number 5136018 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J34J43 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J46A99 ; Catalog Number SBA11DPSBD, UDI/DI 10887488936635 (EA)50887488936633 (CS), Lot Number J70X20 ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8393U ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8123Y ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8671K ; Catalog Number SBA11DPSBE, UDI/DI 10888439904710 (EA)50888439904718 (CS), Lot Number J8692Z ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6806114 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6928758 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5631072 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5891307 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5891310 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 5631071 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 55693537 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264570 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264566 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6264567 ; Catalog Number SBA11DPSBF, UDI/DI 10195594972493 (EA)50195594972491 (CS), Lot Number 6345523 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7280111 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7287567 ; Catalog Number SBA11DPSBG, UDI/DI 10197106471098 (EA)50197106471096 (CS), Lot Number 7332916 ; Catalog Number SBA11MXCP1, UDI/DI 10195594114985 (EA)50195594114983 (CS), Lot Number 5140342 ; Catalog Number SBA11MXCP2, UDI/DI 10195594347819 (EA)50195594347817 (CS), Lot Number 5478804 ; Catalog Number SBA11MXCP3, UDI/DI 10195594366544 (EA)50195594366542 (CS), Lot Number J6367F ; Catalog Number SBA11MXCP4, UDI/DI 10195594416027 (EA)50195594416025 (CS), Lot Number 5533336 ; Catalog Number SBA11MXCP5, UDI/DI 10195594756369 (EA)50195594756367 (CS), Lot Number 6022131 ; Catalog Number SBA11MXCP6, UDI/DI 10195594796587 (EA)50195594796585 (CS), Lot Number 6025787 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6563989 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number J86T81 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6025787 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6264570 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6345522 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487902 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487902 ; Catalog Number SBA11MXCPB, UDI/DI 10888439989816 (EA)50888439989814 (CS), Lot Number 6487904 ; Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number 6487901 ; Catalog Number SBA11MXCPC, UDI/DI 10197106247297 (EA)50197106247295 (CS), Lot Number 6596397 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6788562 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6928760 ; Catalog Number SBA11MXCPD, UDI/DI 10197106427699 (EA)50197106427697 (CS), Lot Number 6928760 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332917 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7163033 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7163103 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7280107 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332910 ; Catalog Number SBA...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jan 22, 2025
Recall initiation date: Nov 8, 2024
Center classification date: Jan 15, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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