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 RECONSTRUCTION PACK,Catalog Number SBA11PRH14; 64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3; 65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4; 66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5; 67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6; 68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7; 69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8; 70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9; 71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB; 72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC; 73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF; 74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG; 75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C; 76) DIEP SIEP PACK,Catalo
FDA recall Z-0908-2025 — Cardinal Health 200, LLC is recalling 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 RECONSTRUCTION PACK,Catalog Number SBA11PRH14; 64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3; 65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4; 66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5; 67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6; 68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7; 69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8; 70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9; 71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB; 72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC; 73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF; 74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG; 75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C; 76) DIEP SIEP PACK,Catalo (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
openFDA drug & device enforcement (recall) reports
FDA recall Z-0908-2025: Cardinal Health 200, LLC is recalling 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 RECONSTRUCTION PACK,Catalog Number SBA11PRH14; 64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3; 65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4; 66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5; 67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6; 68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7; 69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8; 70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9; 71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB; 72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC; 73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF; 74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG; 75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C; 76) DIEP SIEP PACK,Catalo
The FDA logged enforcement record Z-0908-2025: Cardinal Health 200, LLC is voluntarily recalling 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 RECONSTRUCTION PACK,Catalog Number SBA11PRH14; 64) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK3; 65) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK4; 66) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK5; 67) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK6; 68) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK7; 69) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK8; 70) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHK9; 71) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKB; 72) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKC; 73) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKF; 74) PLASTIC RECONSTRUCTION PACK,Catalog Number SBA11PRHKG; 75) STERILE TRANSPHENOIDAL PACK,Catalog Number SBA12TR38C; 76) DIEP SIEP PACK,Catalo — reason: Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-08. Affected lots/codes: 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 SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332906 ; Catalog Number SBA11MXCPE, UDI/DI 10197106484036 (EA)50197106484034 (CS), Lot Number 7332907 ; Catalog Number SBA11PRH10, UDI/DI 10195594702298 (EA)50195594702296 (CS), Lot Number 5891314 ; Catalog Number SBA11PRH11, UDI/DI 10195594765477 (EA)50195594765475 (CS), Lot Number 6025786 ; Catalog Number SBA11PRH12, UDI/DI 10197106016053 (EA)50197106016051 (CS), Lot Number 6025791 ; Catalog Number SBA11PRH13, UDI/DI 10197106100172 (EA)50197106100170 (CS), Lot Number 6345522 ; Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number 157467 ; Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number 22L3440 ; Catalog Number SBA11PRH14, UDI/DI 10197106233610 (EA)50197106233618 (CS), Lot Number 6596396 ; Catalog Number SBA11PRHK3, UDI/DI 10888439745429 (EA)50888439745427 (CS), Lot Number J3464F ; Catalog Number SBA11PRHK4, UDI/DI 10888439947441 (EA)50888439947449 (CS), Lot Number J8124A ; Catalog Number SBA11PRHK5, UDI/DI 10888439992335 (EA)50888439992333 (CS), Lot Number J8692Y ; Catalog Number SBA11PRHK6, UDI/DI 10195594967062 (EA)50195594967060 (CS), Lot Number J86T83 ; Catalog Number SBA11PRHK7, UDI/DI 10195594464950 (EA)50195594464958 (CS), Lot Number 5631074 ; Catalog Number SBA11PRHK8, UDI/DI 10195594542108 (EA)50195594542106 (CS), Lot Number 5888374 ; Catalog Number SBA11PRHK9, UDI/DI 10195594659974 (EA)50195594659972 (CS), Lot Number 5891312 ; Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number J4952D ; Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number J5679G ; Catalog Number SBA11PRHKB, UDI/DI 10888439517910 (EA)50888439517918 (CS), Lot Number J7704H ; Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number J8123W ; Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number J84K01 ; Catalog Number SBA11PRHKC, UDI/DI 10888439881196 (EA)50888439881194 (CS), Lot Number 5747232 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6806115 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6928766 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6928766 ; Catalog Number SBA11PRHKF, UDI/DI 10197106337066 (EA)50197106337064 (CS), Lot Number 6928769 ; Catalog Number SBA11PRHKG, UDI/DI 10197106582015 (EA)50197106582013 (CS), Lot Number 7332917 ; Catalog Number SBA11PRHKG, UDI/DI 10197106582015 (EA)50197106582013 (CS), Lot Number 7332909 ; Catalog Number SBA12TR38C, UDI/DI 10887488792613 (EA)50887488792611 (CS), Lot Number J3987C ; Catalog Number SBA12TR38C, UDI/DI 10887488792613 (EA)50887488792611 (CS), Lot Number J4678G ; Catalog Number SBA13DSBW5, UDI/DI 10888439895087 (EA)50888439895085 (CS), Lot Number J5679K ; Catalog Number SBA13DSBW6, UDI/DI 10195594078287 (EA)50195594078285 (CS), Lot Number 5135984 ; Catalog Number SBA13DSBW7, UDI/DI 10195594128234 (EA)50195594128232 (CS), Lot Number J6367C ; Catalog Number SBA13DSBW8, UDI/DI 10195594208615 (EA)50195594208613 (CS), Lot Number 5140342 ; Catalog Number SBA13DSBW8, UDI/DI 10195594208615 (EA)50195594208613 (CS), Lot Number 5140354 ; Catalog Number SBA13DSBWF, UDI/DI 10887488334868 (EA)50887488334866 (CS), Lot Number J3464F ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J34J42 ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J43U77 ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J53W72 ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J7963G ; Catalog Number SBA13DSBWG, UDI/DI 10888439570076 (EA)50888439570074 (CS), Lot Number J7963H ; Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number J7905G ; Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number J8123Z ; Catalog Number SBA13DSBWH, UDI/DI 10888439885163 (EA)50888439885161 (CS), Lot Number 2003505164 ; Catalog Number SBA13DSBWI, UDI/DI 10195594390129 (EA)50195594390127 (CS), Lot Number 5664102 ; Catalog Number SBA13DSBWI, UDI/DI 10195594390129 (EA)50195594390127 (CS), Lot Number 5664101 ; Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number 5891312 ; Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number 5891314 ; Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number 5891313 ; Catalog Number SBA13DSBWJ, UDI/DI 10195594577117 (EA)50195594577115 (CS), Lot Number 6022131 ; Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number 18B0346 ; Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number 18K2934 ; Catalog Number SBA13HTMGJ, UDI/DI 10888439213171 (EA)50888439213179 (CS), Lot Number 19A0125 ; Catalog Number SBA13TCBCD, UDI/DI 10888439177909 (EA)50888439177907 (CS), Lot Number J3464F ; Catalog Number SBA13TCBCD, UDI/DI 10888439177909 (EA)50888439177907 (CS), Lot Number J4218Z ; Catalog Number SBA53FFK10, UDI/DI 10197106338612 (EA)50197106338610 (CS), Lot Number 6702010 ; Catalog Number SBA53FFK11, UDI/DI 10197106494592 (EA)50197106494590 (CS), Lot Number 6928765 ; Catalog Number SBA53FFK12, UDI/DI 10197106655085 (EA)50197106655083 (CS), Lot Number 7331342 ; Catalog Number SBA53FFKH1, UDI/DI 10195594021399 (EA)50195594021397 (CS), Lot Number J9602T ; Catalog Number SBA53FFKH2, UDI/DI 10195594042035 (EA)50195594042033 (CS), Lot Number J8692W ; Catalog Number SBA53FFKH3, UDI/DI 10195594586843 (EA)50195594586841 (CS), Lot Number 5891309 ; Catalog Number SBA53FFKH4, UDI/DI 10195594813390 (EA)50195594813398 (CS), Lot Number 5891315 ; Catalog Number SBA53FFKH5, UDI/DI 10197106018569 (EA)50197106018567 (CS), Lot Number 6025791 ; Catalog Number SBA53FFKH6, UDI/DI 10197106041987 (EA)50197106041985 (CS), Lot Number 6264570 ; Catalog Number SBA53FFKH7, UDI/DI 10197106083475 (EA)50197106083473 (CS), Lot Number 6264569 ; Catalog Number SBA53FFKH8, UDI/DI 10197106180280 (EA)50197106180288 (CS), Lot Number 6560945 ; Catalog Number SBA53FFKH9, UDI/DI 10197106261156 (EA)50197106261154 (CS), Lot Number 6701852 ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J7963H ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J8123W ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J84K01 ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J8393W ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number J8124A ; Catalog Number SBA53FFKHC, UDI/DI 10888439798852 (EA)50888439798850 (CS), Lot Number PO170874 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number J8693A ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number N/A ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number J86T82 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number J9849F ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5136018 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5618932 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5631074 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5891312 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 5970334 ; Catalog Number SBA53FFKHD, UDI/DI 10888439979671 (EA)50888439979679 (CS), Lot Number 6025786 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332907 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332917 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 6596397 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 6928757 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 6928763 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7127056 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332904 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332914 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332916 ; Catalog Number SBA53FFKHE, UDI/DI 10197106344088 (EA)50197106344086 (CS), Lot Number 7332905 ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number J8671M ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number J8692W ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number 5405626 ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number J6367F ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number 5664099 ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number 5876883 ; Catalog Number SBA5DFGUMB, UDI/DI 10887488367200 (EA)50887488367208 (CS), Lot Number 5891312 ; Catalog Number SBA5DFGUMC, UDI/DI 10197106675984 (EA)50197106675982 (CS), Lot Number 7332910 ; Catalog Number SBA5FSPMM5, UDI/DI 10195594918965 (EA)50195594918963 (CS), Lot Number J8671P ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J3464F ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J34J41 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J46C02 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J4952D ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J53W68 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J46C03 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J5679A ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J7704G ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J8064Y ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J86T81 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J9602T ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number J6050H ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5140342 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5478803 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5664099 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5140345 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5664103 ; Catalog Number SBA5FSPMME, UDI/DI 10887488366265 (EA)50887488366263 (CS), Lot Number 5891312 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7127056 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7280109 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7331342 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7332910 ; Catalog Number SBA60POLHA, UDI/DI 10197106547083 (EA)50197106547081 (CS), Lot Number 7332912 ; Catalog Number SBA60POLHB, UDI/DI 10197106730492 (EA)50197106730490 (CS), Lot Number 7332913 ; Catalog Number SBA60POLHB, UDI/DI 10197106730492 (EA)50197106730490 (CS), Lot Number 7332918 ; Catalog Number SBA73FFKO1, UDI/DI 10197106347904 (EA)50197106347902 (CS), Lot Number 6702012 ; Catalog Number SBA73FFKOA, UDI/DI 10197106288252 (EA)50197106288250 (CS), Lot Number 7163103 ; Catalog Number SBA73FFKOA, UDI/DI 10197106288252 (EA)50197106288250 (CS), Lot Number 6928771 ; Catalog Number SBA73FFKWB, UDI/DI 10197106744550 (EA)50197106744558 (CS), Lot Number 7332915 ; Catalog Number SBA73FFKWB, UDI/DI 10197106744550 (EA)50197106744558 (CS), Lot Number 7332908 ; Catalog Number SBAMHMFB10, UDI/DI 10195594132552 (EA)50195594132550 (CS), Lot Number J6050H ; Catalog Number SBAMHMFB11, UDI/DI 10195594249212 (EA)50195594249210 (CS), Lot Number 5140342 ; Catalog Number SBAMHMFB12, UDI/DI 10195594393137 (EA)50195594393135 (CS), Lot Number 5533333 ; Catalog Number SBAMHMFB13, UDI/DI 10195594520359 (EA)50195594520357 (CS), Lot Number 5140345 ; Catalog Number SBAMHMFB14, UDI/DI 10195594546144 (EA)50195594546142 (CS), Lot Number 5876883 ; Catalog Number SBAMHMFB15, UDI/DI 10197106118993 (EA)50197106118991 (CS), Lot Number 6560943 ; Catalog Number SBAMHMFB16, UDI/DI 10197106321577 (EA)50197106321575 (CS), Lot Number 6560946 ; Catalog Number SBAMHMFBH8, UDI/DI 10888439674149 (EA)50888439674147 (CS), Lot Number J4952C ; Catalog Number SBAMHMFBH9, UDI/DI 10195594055929 (EA)50195594055927 (CS), Lot Number J6367C ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J2977X ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J3987C ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J43U74 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J5679A ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J70X21 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J7704F ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number N/A ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J53W72 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J7905F ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J7963D ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J84K04 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J85W24 ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J8671P ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number J8692Z ; Catalog Number SBAMHMFBHP, UDI/DI 10887488680903 (EA)50887488680901 (CS), Lot Number 5631072 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 5891309 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 5891312 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 5891314 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6025786 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6025785 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 5631069 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6264565 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6025791 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6264569 ; Catalog Number SBAMHMFBHQ, UDI/DI 10195594543600 (EA)50195594543608 (CS), Lot Number 6563988 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 33NFHD ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6563990 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6022130 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6806113 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6914944 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6596397 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6914942 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6928758 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6928757 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7163033 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6928773 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7163082 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 6928772 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7332911 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7332916 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7332908 ; Catalog Number SBAMHMFBHR, UDI/DI 10197106195130 (EA)50197106195138 (CS), Lot Number 7332907 ; Catalog Number SEN11CMCP1, UDI/DI 10888439703269 (EA)50888439703267 (CS), Lot Number J53W67 ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J5679F ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J6050F ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J7963H ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J5679M ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J7905G ; Catalog Number SEN11CMCPA, UDI/DI 10888439620023 (EA)50888439620021 (CS), Lot Number J8393U ; Catalog Number SEN11CMCPB, UDI/DI 10888439941746 (EA)50888439941744 (CS), Lot Number J85W23 ; Catalog Number SEN11CMCPC, UDI/DI 10888439967500 (EA)50888439967508 (CS), Lot Number J8692Y ; Catalog Number SEN11CMCPC, UDI/DI 10888439967500 (EA)50888439967508 (CS), Lot Number J8693A ; Catalog Number SEN11ENN10, UDI/DI 10195594695897 (EA)50195594695895 (CS), Lot Number 6022064 ; Catalog Number SEN11ENN11, UDI/DI 10195594745288 (EA)50195594745286 (CS), Lot Number J6366P ; Catalog Number SEN11ENN12, UDI/DI 10195594780548 (EA)50195594780546 (CS), Lot Number 6279855 ; Catalog Number SEN11ENN13, UDI/DI 10195594845643 (EA)50195594845641 (CS), Lot Number 6345507 ; Catalog Number SEN11ENN14, UDI/DI 10197106019252 (EA)50197106019250 (CS), Lot Number 6487884 ; Catalog Number SEN11ENN15, UDI/DI 10197106239278 (EA)50197106239276 (CS), Lot Number 6775018 ; Catalog Number SEN11ENN16, UDI/DI 10197106321850 (EA)50197106321858 (CS), Lot Number 6701994 ; Catalog Number SEN11ENNY4, UDI/DI 10888439725339 (EA)50888439725337 (CS), Lot Number J53W33 ; Catalog Number SEN11ENNY5, UDI/DI 10195594086879 (EA)50195594086877 (CS), Lot Number 5138318 ; Catalog Number SEN11ENNY6, UDI/DI 10195594132033 (EA)50195594132031 (CS), Lot Number 5138317 ; Catalog Number SEN11ENNY7, UDI/DI 10195594216238 (EA)50195594216236 (CS), Lot Number J8670U ; Catalog Number SEN11ENNY8, UDI/DI 10195594322373 (EA)50195594322371 (CS), Lot Number J6366M ; Catalog Number SEN11ENNY9, UDI/DI 10195594375355 (EA)50195594375353 (CS), Lot Number 5138322 ; Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number J30T23 ; Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number J46A87 ; Catalog Number SEN11ENNYQ, UDI/DI 10888439562545 (EA)50888439562543 (CS), Lot Number J2649N ; Catalog Number SEN11ENNYQ, UDI/DI. A RECORDED FDA enforcement action (occurred=true).
openFDA drug & device enforcement (recall) reports — U.S. FDA
A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.
FDA classified recall Z-0908-2025 as Class II
The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
U.S. FDA recall classification (openFDA enforcement)
occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.
A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.
Ongoing — the recall is still being carried out.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.