Recall archive / FDA device enforcement
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DF... — FDA record Z-1126-2025
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,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:PG40H...
- Reason
- Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 973,785 total units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1126-2025
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 | 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 (eac... |
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.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 19, 2025
- Recall initiation date
- Nov 8, 2024
- Center classification date
- Feb 10, 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.