Recall archive / FDA device enforcement
Cardinal Health Presource Kits: 1) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY... — FDA record Z-1132-2025
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,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG4; 2) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG5 3) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG6 4) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG7 5) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFG8 6) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGM 7) KIT,NASAL SEPTOPLASTY,FAIRVIEW, Catalog Number:PE29NSFGN 8) KIT,CHP SINUS ENDOSCOPY, Catalog Number:PE36ESCHA 9) KIT, SSSC ENT, Catalog Number:PECGOTSN1 10) KIT, SSSC ENT, Catalog Number:PECGOTSN2 11) KIT, SSSC ENT, Catalog Number:PECGOTSN3 12) KIT, SSSC ENT, Catalog Number:PECGOTSNA 13) KIT, SSSC ENT, Catalog Number:PECGOTSNB 14) KIT, SSSC ENT, Catalog Number:PECGOTSNC 15) KIT, SSSC ENT, Catalog Number:PECGOTSND 16) KIT, SSSC ENT, Catalog Number:PECGOTSNE 17) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10O 18) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10P 19) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10Q 20) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10R 21) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10S 22) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA10T 23) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA10Y 24) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA110 25) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA112 26) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA113 27) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA114 28) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA115 29) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA116 30) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA117 31) KIT,MAJOR EAR,PRESBYTERIAN, Catalog Number:PEV2EA118 32) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA119 33) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA120 34) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA121 35) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA123 36) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA124 37) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA125 38) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA126 39) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA127 40) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA128 41) KIT, MAJOR EAR, PRESBYTERIAN, Catalog Number:PEV2EA129 42) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT101 43) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10A 44) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10B 45) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PEV2OT10D 46) KIT, MINOR ENT, MERCY, Catalog Number:PEVNMECHE 47) KIT,ENT ENDOSCOPY,PRESBYTERIAN, Catalog Number:PGV2OT10C 48) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH1 49) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH2 50) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCH3 51) KIT,ENT SINUS ST LOUIS CHILDRE, Catalog Number:PGVMCLCHA 52) ENDO TRAY SSOP PACK, Catalog Number:SBA23ENPC1 53) ENDO TRAY SSOP PACK, Catalog Number:S...
- 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-1132-2025
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) PE29NSFG4, UDI-DI:10195594302870 (each) 50195594302878 (case), Lot Number: 5140385 ; 2) PE29NSFG5, UDI-DI:10195594429980 (each) 50195594429988 (case), Lot Number: 5478805 ; 3) PE29NSFG6, UDI-DI:10195594510046 (each) 50195594510044 (case), Lot Number: 5664108 ; 4) PE29NSFG7, UDI-DI:10197106511206 (each) 50197106511204 (case), Lot Number: 7280115 ; 5) PE29NSFG8, UDI-DI:10197106535981 (each) 50197106535989 (case), Lot Number: 7320240 ; 6) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J3593N ; 7) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J46C07 ; 8) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J4952P ; 9) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679N ; 10) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J5679T ; 11) PE29NSFGM, UDI-DI:10885425554638 (each) 50885425554636 (case), Lot Number: J7905H ; 12) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6701854 ; 13) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7005491 ; 14) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7266056 ; 15) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 7280114 ; 16) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J84K06 ; 17) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693H ; 18) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J8693K ; 19) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J6368Z ; 20) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 21) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: J9197H ; 22) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 5841390 ; 23) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 5533340 ; 24) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6025794 ; 25) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6487916 ; 26) PE29NSFGN, UDI-DI:10888439893311 (each) 50888439893319 (case), Lot Number: 6487917 ; 27) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6563985 ; 28) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6788522 ; 29) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7287564 ; 30) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7349687 ; 31) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 7360443 ; 32) PE36ESCHA, UDI-DI:10197106080856 (each) 50197106080854 (case), Lot Number: 6487899 ; 33) PECGOTSN1, UDI-DI:10195594910358 (each) 50195594910356 (case), Lot Number: J6278X ; 34) PECGOTSN2, UDI-DI:10195594573386 (each) 50195594573384 (case), Lot Number: 5841390 ; 35) PECGOTSN3, UDI-DI:10197106422984 (each) 50197106422982 (case), Lot Number: 7163105 ; 36) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J30T07 ; 37) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J46C05 ; 38) PECGOTSNA, UDI-DI:10888439218886 (each) 50888439218884 (case), Lot Number: J4952N ; 39) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J4952P ; 40) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J4952U ; 41) PECGOTSNB, UDI-DI:10888439649017 (each) 50888439649015 (case), Lot Number: J5679N ; 42) PECGOTSNC, UDI-DI:10888439809640 (each) 50888439809648 (case), Lot Number: J6050A ; 43) PECGOTSNC, UDI-DI:10888439809640 (each) 50888439809648 (case), Lot Number: J70X23 ; 44) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: J84K05 ; 45) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: J85W32 ; 46) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: J9850D ; 47) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5140379 ; 48) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5508060 ; 49) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5631078 ; 50) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 5533340 ; 51) PECGOTSND, UDI-DI:10888439861594 (each) 50888439861592 (case), Lot Number: 6025793 ; 52) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7331349 ; 53) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7163035 ; 54) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7280115 ; 55) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7320240 ; 56) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7331347 ; 57) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7332919 ; 58) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7320243 ; 59) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7280113 ; 60) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7349697 ; 61) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 7349699 ; 62) PECGOTSNE, UDI-DI:10197106064955 (each) 50197106064953 (case), Lot Number: 6487917 ; 63) PEV2EA10O, UDI-DI:10888439393095 (each) 50888439393093 (case), Lot Number: J43W11 ; 64) PEV2EA10O, UDI-DI:10888439393095 (each) 50888439393093 (case), Lot Number: J43W11 ; 65) PEV2EA10P, UDI-DI:10888439619102 (each) 50888439619100 (case), Lot Number: J43W11 ; 66) PEV2EA10P, UDI-DI:10888439619102 (each) 50888439619100 (case), Lot Number: J43W12 ; 67) PEV2EA10P, UDI-DI:10888439619102 (each) 50888439619100 (case), Lot Number: J4952X ; 68) PEV2EA10Q, UDI-DI:10888439687897 (each) 50888439687895 (case), Lot Number: J4952Z ; 69) PEV2EA10Q, UDI-DI:10888439687897 (each) 50888439687895 (case), Lot Number: J6278Y ; 70) PEV2EA10Q, UDI-DI:10888439687897 (each) 50888439687895 (case), Lot Number: J8241C ; 71) PEV2EA10R, UDI-DI:10888439941593 (each) 50888439941591 (case), Lot Number: J7708N ; 72) PEV2EA10S, UDI-DI:10888439967425 (each) 50888439967423 (case), Lot Number: J8998N ; 73) PEV2EA10S, UDI-DI:10888439967425 (each) 50888439967423 (case), Lot Number: J7128Y ; 74) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5533345 ; 75) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5664110 ; 76) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5664110 ; 77) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 5140386 ; 78) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 6022144 ; 79) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 6416696 ; 80) PEV2EA10T, UDI-DI:10195594180188 (each) 50195594180186 (case), Lot Number: 6560951 ; 81) PEV2EA10Y, UDI-DI:10197106546734 (each) 50197106546732 (case), Lot Number: 7333439 ; 82) PEV2EA110, UDI-DI:10195594947125 (each) 50195594947123 (case), Lot Number: J7708P ; 83) PEV2EA112, UDI-DI:10195594456498 (each) 50195594456496 (case), Lot Number: 5140387 ; 84) PEV2EA113, UDI-DI:10195594545642 (each) 50195594545640 (case), Lot Number: 5140387 ; 85) PEV2EA114, UDI-DI:10195594813864 (each) 50195594813862 (case), Lot Number: 6025795 ; 86) PEV2EA115, UDI-DI:10195594859602 (each) 50195594859600 (case), Lot Number: 6279861 ; 87) PEV2EA116, UDI-DI:10197106174913 (each) 50197106174911 (case), Lot Number: 6560950 ; 88) PEV2EA117, UDI-DI:10197106258132 (each) 50197106258130 (case), Lot Number: 6702037 ; 89) PEV2EA118, UDI-DI:10197106289266 (each) 50197106289264 (case), Lot Number: 6702037 ; 90) PEV2EA119, UDI-DI:10197106392294 (each) 50197106392292 (case), Lot Number: 6568688 ; 91) PEV2EA120, UDI-DI:10197106429273 (each) 50197106429271 (case), Lot Number: 7005492 ; 92) PEV2EA121, UDI-DI:10197106479285 (each) 50197106479283 (case), Lot Number: 6560950 ; 93) PEV2EA123, UDI-DI:10197106593875 (each) 50197106593873 (case), Lot Number: 7331477 ; 94) PEV2EA124, UDI-DI:10197106615096 (each) 50197106615094 (case), Lot Number: 7331477 ; 95) PEV2EA125, UDI-DI:10197106626955 (each) 50197106626953 (case), Lot Number: 7331478 ; 96) PEV2EA126, UDI-DI:10197106669181 (each) 50197106669189 (case), Lot Number: 7331478 ; 97) PEV2EA127, UDI-DI:10197106674475 (each) 50197106674473 (case), Lot Number: 7333440 ; 98) PEV2EA128, UDI-DI:10197106715673 (each) 50197106715671 (case), Lot Number: 7333440 ; 99) PEV2EA128, UDI-DI:10197106715673 (each) 50197106715671 (case), Lot Number: 7333441 ; 100) PEV2EA129, UDI-DI:10197106739129 (each) 50197106739127 (case), Lot Number: 7333441 ; 101) PEV2OT101, UDI-DI:10195594008024 (each) 50195594008022 (case), Lot Number: J96A02 ; 102) PEV2OT10A, UDI-DI:10888439619072 (each) 50888439619070 (case), Lot Number: J4679J ; 103) PEV2OT10A, UDI-DI:10888439619072 (each) 50888439619070 (case), Lot Number: J4680A ; 104) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J4950Z ; 105) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J53W12 ; 106) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J7412G ; 107) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J77Z27 ; 108) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J82M03 ; 109) PEV2OT10B, UDI-DI:10888439688634 (each) 50888439688632 (case), Lot Number: J8393C ; 110) PEV2OT10D, UDI-DI:10888439967401 (each) 50888439967409 (case), Lot Number: J96A01 ; 111) PEVNMECHE, UDI-DI:10887488683201 (each) 50887488683209 (case), Lot Number: J5679T ; 112) PGV2OT10C, UDI-DI:10888439393071 (each) 50888439393079 (case), Lot Number: J4678Z ; 113) PGVMCLCH1, UDI-DI:10888439691290 (each) 50888439691298 (case), Lot Number: J46C12 ; 114) PGVMCLCH2, UDI-DI:10197106459195 (each) 50197106459193 (case), Lot Number: 7160518 ; 115) PGVMCLCH3, UDI-DI:10197106525593 (each) 50197106525591 (case), Lot Number: 7163124 ; 116) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 7360541 ; 117) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 6788692 ; 118) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 7287574 ; 119) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J4220A ; 120) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J43W15 ; 121) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6022K ; 122) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6372Z ; 123) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J8241D ; 124) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J4953F ; 125) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J84K11 ; 126) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J87C82 ; 127) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5136000 ; 128) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5140389 ; 129) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6935J ; 130) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J6935H ; 131) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: I2131399 ; 132) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5664113 ; 133) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J65K18 ; 134) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: J65K19 ; 135) PGVMCLCHA, UDI-DI:10888439573299 (each) 50888439573297 (case), Lot Number: 5876884 ; 136) PGVMCLCHA,... |
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.