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Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) ...

FDA Device Recall #Z-1126-2025 — Class II — November 8, 2024

Recall Summary

Recall Number Z-1126-2025
Classification Class II — Moderate risk
Date Initiated November 8, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health 200, LLC
Location Waukegan, IL
Product Type Devices
Quantity 973,785 total units

Product Description

Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5) KIT,DIEP FLAP , Catalog Number:PB23DFCM7; 6) KIT,DIEP FLAP , Catalog Number:PB23DFCMA; 7) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ10; 8) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ11; 9) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ12; 10) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ13; 11) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ14; 12) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ15; 13) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ16; 14) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ17; 15) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ18; 16) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ19; 17) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ20; 18) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU1; 19) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU2; 20) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU3; 21) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU4; 22) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU5; 23) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU6; 24) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU7; 25) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU8; 26) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU9; 27) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUA; 28) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUB; 29) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUC; 30) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUD; 31) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUE; 32) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUF; 33) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU2; 34) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU3; 35) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU4; 36) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU5; 37) KIT, HEAD AND NECK , Catalog Number:PG40HNAJUC; 38) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ10; 39) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ11; 40) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ12; 41) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ13; 42) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ14; 43) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ15; 44) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ16; 45) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ17; 46) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ18; 47) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ19; 48) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ20; 49) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ21; 50) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ22; 51) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ23; 52) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ24; 53) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU4; 54) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU5; 55) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU6; 56) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU7; 57) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU8; 58) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU9; 59) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUE; 60) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUF; 61) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME1; 62) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME2; 63) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME3; 64) KIT, WILLIAMS SPINE , Cat

Reason for Recall

Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.

Distribution Pattern

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

Lot / Code Information

1) PB23DFCM3, UDI-DI:10888439587050 (each) 50888439587058 (case), Lot Number: J37U13 ; 2) PB23DFCM4, UDI-DI:10888439601053 (each) 50888439601051 (case), Lot Number: J37U14 ; 3) PB23DFCM5, UDI-DI:10888439641790 (each) 50888439641798 (case), Lot Number: J46C08 ; 4) PB23DFCM6, UDI-DI:10888439836172 (each) 50888439836170 (case), Lot Number: J6050A ; 5) PB23DFCM7, UDI-DI:10888439853087 (each) 50888439853085 (case), Lot Number: J7704J ; 6) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J4952P ; 7) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J53W77 ; 8) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J5679N ; 9) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J84K06 ; 10) PB23DFCMA, UDI-DI:10887488531298 (each) 50887488531296 (case), Lot Number: J85W31 ; 11) PE40HNAJ10, UDI-DI:10195594746513 (each) 50195594746511 (case), Lot Number: 5918338 ; 12) PE40HNAJ11, UDI-DI:10195594777685 (each) 50195594777683 (case), Lot Number: 6279857 ; 13) PE40HNAJ12, UDI-DI:10195594808051 (each) 50195594808059 (case), Lot Number: 5649225 ; 14) PE40HNAJ13, UDI-DI:10195594878672 (each) 50195594878670 (case), Lot Number: 6279859 ; 15) PE40HNAJ14, UDI-DI:10197106057902 (each) 50197106057900 (case), Lot Number: 6487892 ; 16) PE40HNAJ15, UDI-DI:10197106116449 (each) 50197106116447 (case), Lot Number: 6487896 ; 17) PE40HNAJ16, UDI-DI:10197106138632 (each) 50197106138630 (case), Lot Number: 5 ; 18) PE40HNAJ16, UDI-DI:10197106138632 (each) 50197106138630 (case), Lot Number: 6560940 ; 19) PE40HNAJ17, UDI-DI:10197106224205 (each) 50197106224203 (case), Lot Number: 6568677 ; 20) PE40HNAJ18, UDI-DI:10197106480168 (each) 50197106480166 (case), Lot Number: 7197963 ; 21) PE40HNAJ19, UDI-DI:10197106571453 (each) 50197106571451 (case), Lot Number: 7280098 ; 22) PE40HNAJ20, UDI-DI:10197106587300 (each) 50197106587308 (case), Lot Number: 7287558 ; 23) PE40HNAJU1, UDI-DI:10195594142469 (each) 50195594142467 (case), Lot Number: J9602A ; 24) PE40HNAJU2, UDI-DI:10195594240776 (each) 50195594240774 (case), Lot Number: J9699U ; 25) PE40HNAJU3, UDI-DI:10195594358556 (each) 50195594358554 (case), Lot Number: 5324049 ; 26) PE40HNAJU4, UDI-DI:10195594448806 (each) 50195594448804 (case), Lot Number: 5533323 ; 27) PE40HNAJU5, UDI-DI:10195594541224 (each) 50195594541222 (case), Lot Number: 5565994 ; 28) PE40HNAJU6, UDI-DI:10195594585716 (each) 50195594585714 (case), Lot Number: 5664093 ; 29) PE40HNAJU7, UDI-DI:10195594629632 (each) 50195594629630 (case), Lot Number: 5775805 ; 30) PE40HNAJU8, UDI-DI:10195594666194 (each) 50195594666192 (case), Lot Number: 5918339 ; 31) PE40HNAJU9, UDI-DI:10195594700324 (each) 50195594700322 (case), Lot Number: 6022074 ; 32) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: J8393H ; 33) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 5858463 ; 34) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6702004 ; 35) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6702005 ; 36) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6909986 ; 37) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6416698 ; 38) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6987101 ; 39) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 7287561 ; 40) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 7280096 ; 41) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: J7905A ; 42) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: J8064N ; 43) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 5631065 ; 44) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 6279860 ; 45) PE40HNAJUA, UDI-DI:10888439948394 (each) 50888439948392 (case), Lot Number: 5858463 ; 46) PE40HNAJUB, UDI-DI:10197106566732 (each) 50197106566730 (case), Lot Number: 7280096 ; 47) PE40HNAJUC, UDI-DI:10197106630389 (each) 50197106630387 (case), Lot Number: 7287559 ; 48) PE40HNAJUC, UDI-DI:10197106630389 (each) 50197106630387 (case), Lot Number: 7331327 ; 49) PE40HNAJUD, UDI-DI:10197106663776 (each) 50197106663774 (case), Lot Number: 7332883 ; 50) PE40HNAJUE, UDI-DI:10197106692929 (each) 50197106692927 (case), Lot Number: 7332890 ; 51) PE40HNAJUE, UDI-DI:10197106692929 (each) 50197106692927 (case), Lot Number: 7287559 ; 52) PE40HNAJUF, UDI-DI:10197106755235 (each) 50197106755233 (case), Lot Number: 7332892 ; 53) PE40HNAJUF, UDI-DI:10197106755235 (each) 50197106755233 (case), Lot Number: 6779831 ; 54) PG40HNAJU2, UDI-DI:10888439568592 (each) 50888439568590 (case), Lot Number: J37U04 ; 55) PG40HNAJU3, UDI-DI:10888439786200 (each) 50888439786208 (case), Lot Number: J5678G ; 56) PG40HNAJU3, UDI-DI:10888439786200 (each) 50888439786208 (case), Lot Number: J5678J ; 57) PG40HNAJU3, UDI-DI:10888439786200 (each) 50888439786208 (case), Lot Number: J6278K ; 58) PG40HNAJU4, UDI-DI:10888439879537 (each) 50888439879535 (case), Lot Number: J7904Z ; 59) PG40HNAJU5, UDI-DI:10888439903829 (each) 50888439903827 (case), Lot Number: J7904Z ; 60) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J37U05 ; 61) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J4219Y ; 62) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J4219Z ; 63) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J46A94 ; 64) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J46A95 ; 65) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J4951Y ; 66) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J7498X ; 67) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J8393H ; 68) PG40HNAJUC, UDI-DI:10888439342864 (each) 50888439342862 (case), Lot Number: J8393K ; 69) PG40HNJ10, UDI-DI:10195594042929 (each) 50195594042927 (case), Lot Number: J9602A ; 70) PG40HNJ11, UDI-DI:10195594116903 (each) 50195594116901 (case), Lot Number: 5140303 ; 71) PG40HNJ12, UDI-DI:10195594252014 (each) 50195594252012 (case), Lot Number: 5140306 ; 72) PG40HNJ13, UDI-DI:10195594298098 (each) 50195594298096 (case), Lot Number: 5140335 ; 73) PG40HNJ14, UDI-DI:10195594401672 (each) 50195594401670 (case), Lot Number: 5478801 ; 74) PG40HNJ15, UDI-DI:10195594471101 (each) 50195594471109 (case), Lot Number: 5565993 ; 75) PG40HNJ16, UDI-DI:10195594531249 (each) 50195594531247 (case), Lot Number: J97W47 ; 76) PG40HNJ17, UDI-DI:10195594561390 (each) 50195594561398 (case), Lot Number: 5664091 ; 77) PG40HNJ18, UDI-DI:10195594631321 (each) 50195594631329 (case), Lot Number: 5140301 ; 78) PG40HNJ19, UDI-DI:10195594700232 (each) 50195594700230 (case), Lot Number: 6022074 ; 79) PG40HNJ20, UDI-DI:10195594773083 (each) 50195594773081 (case), Lot Number: 6025778 ; 80) PG40HNJ21, UDI-DI:10195594791742 (each) 50195594791740 (case), Lot Number: 6279857 ; 81) PG40HNJ22, UDI-DI:10195594834920 (each) 50195594834928 (case), Lot Number: 6025781 ; 82) PG40HNJ23, UDI-DI:10195594867980 (each) 50195594867988 (case), Lot Number: 6416697 ; 83) PG40HNJ24, UDI-DI:10197106013274 (each) 50197106013272 (case), Lot Number: 5970332 ; 84) PG40HNJU4, UDI-DI:10888439567311 (each) 50888439567319 (case), Lot Number: J37U04 ; 85) PG40HNJU5, UDI-DI:10888439616682 (each) 50888439616680 (case), Lot Number: J4219Z ; 86) PG40HNJU6, UDI-DI:10888439689907 (each) 50888439689905 (case), Lot Number: J5678H ; 87) PG40HNJU7, UDI-DI:10888439786446 (each) 50888439786444 (case), Lot Number: J4951Y ; 88) PG40HNJU8, UDI-DI:10888439854329 (each) 50888439854327 (case), Lot Number: J79H50 ; 89) PG40HNJU9, UDI-DI:10888439963571 (each) 50888439963579 (case), Lot Number: J8393H ; 90) PG40HNJUE, UDI-DI:10888439342833 (each) 50888439342831 (case), Lot Number: J46A95 ; 91) PG40HNJUE, UDI-DI:10888439342833 (each) 50888439342831 (case), Lot Number: J6366T ; 92) PG40HNJUE, UDI-DI:10888439342833 (each) 50888439342831 (case), Lot Number: J7904Z ; 93) PG40HNJUF, UDI-DI:10888439948400 (each) 50888439948408 (case), Lot Number: J6278P ; 94) PG40HNJUF, UDI-DI:10888439948400 (each) 50888439948408 (case), Lot Number: J7905A ; 95) PN23WGME1, UDI-DI:10197106553213 (each) 50197106553211 (case), Lot Number: 7055825 ; 96) PN23WGME1, UDI-DI:10197106553213 (each) 50197106553211 (case), Lot Number: 7280093 ; 97) PN23WGME2, UDI-DI:10197106594155 (each) 50197106594153 (case), Lot Number: 7280048 ; 98) PN23WGME2, UDI-DI:10197106594155 (each) 50197106594153 (case), Lot Number: 7280091 ; 99) PN23WGME3, UDI-DI:10197106735046 (each) 50197106735044 (case), Lot Number: 7332831 ; 100) PN23WGME3, UDI-DI:10197106735046 (each) 50197106735044 (case), Lot Number: 7349672 ; 101) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7055826 ; 102) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7280092 ; 103) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7280055 ; 104) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7287533 ; 105) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7280061 ; 106) PN23WGMEA, UDI-DI:10197106508008 (each) 50197106508006 (case), Lot Number: 7287534 ; 107) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7287466 ; 108) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331338 ; 109) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7287483 ; 110) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331319 ; 111) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331284 ; 112) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331323 ; 113) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331456 ; 114) PN23WGMEB, UDI-DI:10197106557570 (each) 50197106557578 (case), Lot Number: 7331313 ; 115) PN23WGMEC, UDI-DI:10197106770887 (each) 50197106770885 (case), Lot Number: 7280043 ; 116) PN23WGMEC, UDI-DI:10197106770887 (each) 50197106770885 (case), Lot Number: 7331320 ; 117) PN43SPUN1, UDI-DI:10197106570739 (each) 50197106570737 (case), Lot Number: 7287491 ; 118) PN43SPUN2, UDI-DI:10197106592663 (each) 50197106592661 (case), Lot Number: 7163141 ; 119) PN43SPUN3, UDI-DI:10197106647974 (each) 50197106647972 (case), Lot Number: 7331296 ; 120) PN43SPUNA, UDI-DI:10197106200025 (each) 50197106200023 (case), Lot Number: 6116185 ; 121) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 6701984 ; 122) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 7331296 ; 123) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 7331430 ; 124) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 7331430 ; 125) PN43SPUNB, UDI-DI:10197106542385 (each) 50197106542383 (case), Lot Number: 7332848 ; 126) PN4EACWIA, UDI-DI:10197106335192 (each) 50197106335190 (case), Lot Number: 7122012 ; 127) PN4EACWIA, UDI-DI:10197106335192 (each) 50197106335190 (case), Lot Number: 7160478 ; 128) PN4EACWIA, UDI-DI:10197106335192 (each) 50197106335190 (case), Lot Number: 7260071 ; 129) PN4EACWIB, UDI-DI:10197106525913 (each) 50197106525911 (case), Lot Number: 6560923 ; 130) PW40HNJU1, UDI-DI:10197106158913 (each) 50197106158911 (case), Lot Number: 6560940 ; 131) PW40HNJU2, UDI-DI:10197106226179 (each) 50197106226177 (case), Lot Number: 5 ; 132) PW40HNJU2, UDI-DI:10197106226179 (each) 50197106226177 (case), Lot Number: 6568677 ; 133) PW40HNJU3, UDI-DI:10197106304631 (each) 50197106304639 (case), Lot Number: 6702004 ; 134) PW40HNJU4, UDI-DI:10197106386293 (each) 50197106386291 (case), Lot Number: 6717949 ; 135) PW40HNJU5, UDI-DI:10197106454565 (each) 50197106454563 (case), Lot Number: 6779831 ; 136) PW40HNJU6, UDI-DI:10197106496633 (each) 50197106496631 (case), Lot Number: 6909988 ; 137) PW40HNJU7, UDI-DI:10197106579978 (each) 50197106579976 (case), Lot Number: 7280095 ; 138) PW40HNJUA, UDI-DI:10197106014189 (each) 50197106014187 (case), Lot Number: 7280097 ; 139) PW40HNJUA, UDI-DI:10197106014189 (each) 50197106014187 (case), Lot Number: 7331340 ; 140) PW40HNJUB, UDI-DI:10197106630341 (each) 50197106630349 (case), Lot Number: 7331327 ; 141) PW40HNJUC, UDI-DI:10197106663745 (each) 50197106663743 (case), Lot Number: 7332886 ; 142) PW40HNJUD, UDI-DI:10197106692875 (each) 50197106692873 (case), Lot Number: 7332883 ; 143) PW40HNJUE, UDI-DI:10197106758601 (each) 50197106758609 (case), Lot Number: 7332892 ; 144) SBA30MFOCA, UDI-DI:10195594120450 (each) 50195594120458 (case), Lot Number: J9699T ; 145) SBA30MFOCA, UDI-DI:10195594120450 (each) 50195594120458 (case), Lot Number: 5324049 ; 146) SBA30MFOCB, UDI-DI:10195594378011 (each) 50195594378019 (case), Lot Number: 5405624 ; 147) SBA30MFOCB, UDI-DI:10195594378011 (each) 50195594378019 (case), Lot Number: 5508057 ; 148) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5858463 ; 149) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 6560942 ; 150) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5565993 ; 151) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: J97W47 ; 152) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5664093 ; 153) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5664091 ; 154) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 5664094 ; 155) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 6022075 ; 156) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 6416700 ; 157) SBA30MFOCC, UDI-DI:10195594446321 (each) 50195594446329 (case), Lot Number: 6487896 ; 158) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 6717950 ; 159) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 6717949 ; 160) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 7280095 ; 161) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 7332887 ; 162) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 7332883 ; 163) SBA30MFOCD, UDI-DI:10197106288559 (each) 50197106288557 (case), Lot Number: 7332888 ; 164) SBA30PEMD1, UDI-DI:10195594762902 (each) 50195594762900 (case), Lot Number: 6133661 ; 165) SBA38FTVAC, UDI-DI:10888439938210 (each) 50888439938218 (case), Lot Number: J6786C ; 166) SBA38FTVAD, UDI-DI:10195594972226 (each) 50195594972224 (case), Lot Number: 6701941 ; 167) SBA38FTVAD, UDI-DI:10195594972226 (each) 50195594972224 (case), Lot Number: 6701940 ; 168) SBA38FTVAD, UDI-DI:10195594972226 (each) 50195594972224 (case), Lot Number: 5664019 ; 169) SBA38FTVAD, UDI-DI:10195594972226 (each) 50195594972224 (case), Lot Number: 5891283 ; 170) SBA38FTVAE, UDI-DI:10197106422212 (each) 50197106422210 (case), Lot Number: 7122097 ; 171) SBA38FTVAE, UDI-DI:10197106422212 (each) 50197106422210 (case), Lot Number: 6485588 ; 172) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7360139 ; 173) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7280055 ; 174) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6701938 ; 175) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7005442 ; 176) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6701970 ; 177) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7260067 ; 178) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7287457 ; 179) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7332803 ; 180) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: J4218Z ; 181) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 7332814 ; 182) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: J4680J ; 183) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: J4950U ; 184) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: J6277R ; 185) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 5775788 ; 186) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 5891293 ; 187) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6022056 ; 188) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6264448 ; 189) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6345500 ; 190) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6485576 ; 191) SBA38LMCID, UDI-DI:10887488575568 (each) 50887488575566 (case), Lot Number: 6683719 ; 192) SBA40FPJUB, UDI-DI:10197106722121 (each) 50197106722129 (case), Lot Number: 6779832 ; 193) SBA40FPJUB, UDI-DI:10197106722121 (each) 50197106722129 (case), Lot Number: 7332890 ; 194) SBA43BSUNA, UDI-DI:10197106212455 (each) 50197106212453 (case), Lot Number: 6485593 ; 195) SBA4JDFCB1, UDI-DI:10197106730447 (each) 50197106730445 (case), Lot Number: 7349697 ; 196) SBA4JDFCBA, UDI-DI:10197106527900 (each) 50197106527908 (case), Lot Number: 7320242 ; 197) SBA4JDFCBC, UDI-DI:10197106654477 (each) 50197106654475 (case), Lot Number: 7320243 ; 198) SBA4JFDCM1, UDI-DI:10197106731321 (each) 50197106731329 (case), Lot Number: 7349697 ; 199) SBA4JFDCMA, UDI-DI:10197106518977 (each) 50197106518975 (case), Lot Number: 7320241 ; 200) SBA51FFK10, UDI-DI:10195594738402 (each) 50195594738400 (case), Lot Number: 6232004 ; 201) SBA51FFK11, UDI-DI:10195594890940 (each) 50195594890948 (case), Lot Number: 6364783 ; 202) SBA51FFK12, UDI-DI:10197106025451 (each) 50197106025459 (case), Lot Number: 6416684 ; 203) SBA51FFK13, UDI-DI:10197106192658 (each) 50197106192656 (case), Lot Number: 6416685 ; 204) SBA51FFK14, UDI-DI:10197106252178 (each) 50197106252176 (case), Lot Number: 6748352 ; 205) SBA51FFK15, UDI-DI:10197106298336 (each) 50197106298334 (case), Lot Number: 6470287 ; 206) SBA51FFK16, UDI-DI:10197106367636 (each) 50197106367634 (case), Lot Number: 6928777 ; 207) SBA51FFK17, UDI-DI:10197106512166 (each) 50197106512164 (case), Lot Number: 7280089 ; 208) SBA51FFK18, UDI-DI:10197106553718 (each) 50197106553716 (case), Lot Number: 7280093 ; 209) SBA51FFK19, UDI-DI:10197106593585 (each) 50197106593583 (case), Lot Number: 7280090 ; 210) SBA51FFK20, UDI-DI:10197106661352 (each) 50197106661350 (case), Lot Number: 7332856 ; 211) SBA51FFK21, UDI-DI:10197106753675 (each) 50197106753673 (case), Lot Number: 7349671 ; 212) SBA51FFK22, UDI-DI:10197106779521 (each) 50197106779529 (case), Lot Number: 7332878 ; 213) SBA51FFKC3, UDI-DI:10888439755107 (each) 50888439755105 (case), Lot Number: J6278G ; 214) SBA51FFKC4, UDI-DI:10888439773248 (each) 50888439773246 (case), Lot Number: J6278J ; 215) SBA51FFKC5, UDI-DI:10195594967352 (each) 50195594967350 (case), Lot Number: J9602H ; 216) SBA51FFKC6, UDI-DI:10195594067557 (each) 50195594067555 (case), Lot Number: 20M067262 ; 217) SBA51FFKC6, UDI-DI:10195594067557 (each) 50195594067555 (case), Lot Number: 5135994 ; 218) SBA51FFKC7, UDI-DI:10195594167332 (each) 50195594167330 (case), Lot Number: 5138327 ; 219) SBA51FFKC8, UDI-DI:10195594310912 (each) 50195594310910 (case), Lot Number: 5405617 ; 220) SBA51FFKC9, UDI-DI:10195594700027 (each) 50195594700025 (case), Lot Number: 6022070 ; 221) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J37T95 ; 222) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J43U72 ; 223) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J46A82 ; 224) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J74A02 ; 225) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J4951U ; 226) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J8064R ; 227) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J86N66 ; 228) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J70X09 ; 229) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: J70X08 ; 230) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5533310 ; 231) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5631062 ; 232) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5405618 ; 233) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5508052 ; 234) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5508054 ; 235) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5664049 ; 236) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 5533321 ; 237) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 6470285 ; 238) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 6470287 ; 239) SBA51FFKCE, UDI-DI:10885425756261 (each) 50885425756269 (case), Lot Number: 6563975 ; 240) SBA51FFKCF, UDI-DI:10197106344910 (each) 50197106344918 (case), Lot Number: 7005466 ; 241) SBA51MFKO1, UDI-DI:10197106800713 (each) 50197106800711 (case), Lot Number: 7331351 ; 242) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 6779960 ; 243) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 6788670 ; 244) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7160529 ; 245) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7163105 ; 246) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7266055 ; 247) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7160538 ; 248) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7160538 ; 249) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7280116 ; 250) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7320241 ; 251) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7280112 ; 252) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7332922 ; 253) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7332921 ; 254) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7349698 ; 255) SBA51MFKOA, UDI-DI:10197106223819 (each) 50197106223817 (case), Lot Number: 7349699 ; 256) SBA51PMKO9, UDI-DI:10197106490426 (each) 50197106490424 (case), Lot Number: 7265984 ; 257) SBA51PMKOE, UDI-DI:10197106223901 (each) 50197106223909 (case), Lot Number: 6775048 ; 258) SBA51PMKOF, UDI-DI:10197106527207 (each) 50197106527205 (case), Lot Number: 7332874 ; 259) SBA51PMKOF, UDI-DI:10197106527207 (each) 50197106527205 (case), Lot Number: 7280090 ; 260) SBA51PMKOF, UDI-DI:10197106527207 (each) 50197106527205 (case), Lot Number: 7287539 ; 261) SBA51PMKOF, UDI-DI:10197106527207 (each) 50197106527205 (case), Lot Number: 7332861 ; 262) SBA5FDLMM2, UDI-DI:10195594883492 (each) 50195594883490 (case), Lot Number: 5530913 ; 263) SBA5FDLMM3, UDI-DI:10197106248997 (each) 50197106248995 (case), Lot Number: 6907763 ; 264) SBA5FDLMMB, UDI-DI:10885425502578 (each) 50885425502576 (case), Lot Number: J4218Z ; 265) SBA5FDLMMB, UDI-DI:10885425502578 (each) 50885425502576 (case), Lot Number: J4950Y ; 266) SBA5FDLMMB, UDI-DI:10885425502578 (each) 50885425502576 (case), Lot Number: J4680A ; 267) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7280059 ; 268) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7055832 ; 269) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7331287 ; 270) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6560923 ; 271) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7331457 ; 272) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 7332845 ; 273) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J7609N ; 274) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J7904N ; 275) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J8123N ; 276) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J8692M ; 277) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J96N39 ; 278) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: J9602N ; 279) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5311244 ; 280) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5138168 ; 281) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5631042 ; 282) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5664033 ; 283) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 5891282 ; 284) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6025767 ; 285) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6345502 ; 286) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6560930 ; 287) SBA5FDLMMC, UDI-DI:10888439831726 (each) 50888439831724 (case), Lot Number: 6683719 ; 288) SBA69FFC18, UDI-DI:10888439587111 (each) 50888439587119 (case), Lot Number: J3593N ; 289) SBA69FFC19, UDI-DI:10888439650921 (each) 50888439650929 (case), Lot Number: J46C07 ; 290) SBA69FFC20, UDI-DI:10888439668124 (each) 50888439668122 (case), Lot Number: J4952N ; 291) SBA69FFC21, UDI-DI:10888439738261 (each) 50888439738269 (case), Lot Number: J53W77 ; 292) SBA69FFC22, UDI-DI:10888439852011 (each) 50888439852019 (case), Lot Number: J7704J ; 293) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J37U13 ; 294) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J53W78 ; 295) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J43U79 ; 296) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J7963U ; 297) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J7963U ; 298) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J85W32 ; 299) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J6278W ; 300) SBA69FFCIZ, UDI-DI:10888439507966 (each) 50888439507964 (case), Lot Number: J6368X ; 301) SBA69FFKW2, UDI-DI:10195594163426 (each) 50195594163424 (case), Lot Number: J9850H ; 302) SBA69FFKW3, UDI-DI:10195594381714 (each) 50195594381712 (case), Lot Number: 5508060 ; 303) SBA69FFKW4, UDI-DI:10195594717445 (each) 50195594717443 (case), Lot Number: 5970335 ; 304) SBA69FFKW5, UDI-DI:10197106209110 (each) 50197106209118 (case), Lot Number: 6701854 ; 305) SBA69FFKW6, UDI-DI:10197106395783 (each) 50197106395781 (case), Lot Number: 7160529 ; 306) SBA69FFKW7, UDI-DI:10197106716670 (each) 50197106716678 (case), Lot Number: 7332924 ; 307) SBA69FFKWM, UDI-DI:10888439589658 (each) 50888439589656 (case), Lot Number: J4952N ; 308) SBA69FFKWM, UDI-DI:10888439589658 (each) 50888439589656 (case), Lot Number: J5679N ; 309) SBA69FFKWM, UDI-DI:10888439589658 (each) 50888439589656 (case), Lot Number: J8693M ; 310) SBA69FFKWM, UDI-DI:10888439589658 (each) 50888439589656 (case), Lot Number: 5664108 ; 311) SBA69FFKWN, UDI-DI:10195594529284 (each) 50195594529282 (case), Lot Number: 6788668 ; 312) SBA69FFKWN, UDI-DI:10195594529284 (each) 50195594529282 (case), Lot Number: 6133662 ; 313) SBA69FFKWP, UDI-DI:10197106563731 (each) 50197106563739 (case), Lot Number: 7332920 ; 314) SBA69MFSU1, UDI-DI:10195594057909 (each) 50195594057907 (case), Lot Number: J9602W ; 315) SBA69MFSU2, UDI-DI:10195594353841 (each) 50195594353849 (case), Lot Number: 5140385 ; 316) SBA69MFSU3, UDI-DI:10195594448370 (each) 50195594448378 (case), Lot Number: 5533341 ; 317) SBA69MFSU4, UDI-DI:10197106058350 (each) 50197106058358 (case), Lot Number: 6560947 ; 318) SBA69MFSU5, UDI-DI:10197106104736 (each) 50197106104734 (case), Lot Number: 6560948 ; 319) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6788668 ; 320) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6788669 ; 321) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 6779959 ; 322) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7005491 ; 323) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7163105 ; 324) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7163105 ; 325) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7266056 ; 326) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7269982 ; 327) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7280113 ; 328) SBA69MFSUB, UDI-DI:10195594949167 (each) 50195594949165 (case), Lot Number: 7280115

Other Recalls from Cardinal Health 200, LLC

Recall # Classification Product Date
Z-1203-2026 Class II Chest Drainage Units and Accessories: Produc... Dec 26, 2025
Z-0897-2026 Class II ChemoPlus gowns: Product Code Product Descript... Nov 12, 2025
Z-0211-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025
Z-0207-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025
Z-0208-2026 Class II Salem Sump PVC Tubes: Product Code/Product N... Sep 18, 2025

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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