Recall archive / FDA device enforcement
Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Numb... — FDA record Z-2942-2026
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 Jul 14, 2026. 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) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY , Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 5) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU8; 6) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLH9; 7) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHC; 8) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHD; 9) KIT, TRIPOINT SPINE , Catalog Number: PN1DTSLHE; 10) KIT,NEURO , Catalog Number: PN21OTMC6; 11) KIT,NEURO , Catalog Number: PN21OTMC7; 12) KIT,NEURO , Catalog Number: PN21OTMCC; 13) KIT,NEURO , Catalog Number: PN21OTMCD; 14) KIT, MER CRANI , Catalog Number: PN33CRMYB; 15) KIT,CHP BASIC NEURO , Catalog Number: PN36NBCHB; 16) KIT, CRANIOTOMY , Catalog Number: PN40CKC27; 17) KIT, CRANIOTOMY , Catalog Number: PN40CKC28; 18) KIT, CRANIOTOMY , Catalog Number: PN40CKC29; 19) KIT, CRANIOTOMY , Catalog Number: PN40CKCFC; 20) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMB; 21) KIT, BAL LUMBAR LAMINECTOMY , Catalog Number: PNCGLLBMC; 22) BASIC PACK , Catalog Number: SBA73BPGCA; 23) FACIAL FEMINIZATION PACK , Catalog Number: SBA73FFKW9; 24) E BASIC MILLER PACK , Catalog Number: SBA95BMHH6; 25) E BASIC MILLER PACK , Catalog Number: SBA95BMHH7; 26) E BASIC MILLER PACK , Catalog Number: SBA95BMHH8; 27) E BASIC MILLER PACK , Catalog Number: SBA95BMHHF; 28) E BASIC MILLER PACK , Catalog Number: SBA95BMHHG; 29) E BASIC MILLER PACK , Catalog Number: SBA95BMHHH; 30) TRAM PACK , Catalog Number: SBA95TPD10; 31) TRAM PACK , Catalog Number: SBA95TPD11; 32) TRAM PACK , Catalog Number: SBA95TPDU6; 33) TRAM PACK , Catalog Number: SBA95TPDU7; 34) TRAM PACK , Catalog Number: SBA95TPDU8; 35) TRAM PACK , Catalog Number: SBA95TPDU9; 36) TRAM PACK , Catalog Number: SBA95TPDUP; 37) TRAM PACK , Catalog Number: SBA95TPDUQ; 38) PLASTIC SURGERY PACK ,
- Reason
- Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 36862 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2942-2026
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) 21-4720B, UDI-DI: 10888439934663(each), 50888439934661(case), Lot Number: 94970 ; 2) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10339 ; 3) 21-4720C, UDI-DI: 10197106675793(each), 50197106675791(case), Lot Number: 10586 ; 4) PECGMLBOB, UDI-DI: 10197106067406(each), 50197106067404(case), Lot Number: 4366 ; 5) PECGNAAU8, UDI-DI: 10197106967706(each), 50197106967704(case), Lot Number: 12206 ; 6) PECGNAAUJ, UDI-DI: 10197106894514(each), 50197106894512(case), Lot Number: 11851 ; 7) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14813 ; 8) PN1DTSLH9, UDI-DI: 10198956120051(each), 50198956120059(case), Lot Number: 14039 ; 9) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 8160-1 ; 10) PN1DTSLHC, UDI-DI: 10197106492222(each), 50197106492220(case), Lot Number: 3747 ; 11) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 12) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10392 ; 13) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 14) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 15) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11020 ; 16) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 12641 ; 17) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 13289 ; 18) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 19) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 20) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 21) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 9243-1 ; 22) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 10586 ; 23) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 11851 ; 24) PN1DTSLHD, UDI-DI: 10197106660195(each), 50197106660193(case), Lot Number: 12641 ; 25) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-4 ; 26) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: N/A ; 27) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-5 ; 28) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463-7 ; 29) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15192 ; 30) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15192 ; 31) PN1DTSLHE, UDI-DI: 10198956197909(each), 50198956197907(case), Lot Number: 15463 ; 32) PN21OTMC6, UDI-DI: 10195594763718(each), 50195594763716(case), Lot Number: 3024 ; 33) PN21OTMC7, UDI-DI: 10197106267660(each), 50197106267668(case), Lot Number: 6033 ; 34) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 4730 ; 35) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 93845 ; 36) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3024 ; 37) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-1 ; 38) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-2 ; 39) PN21OTMCC, UDI-DI: 10887488783215(each), 50887488783213(case), Lot Number: 3916-3 ; 40) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7390 ; 41) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7390-1 ; 42) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7748 ; 43) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7784-1 ; 44) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 8160-1 ; 45) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 7784-2 ; 46) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 9243 ; 47) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 8160-1 ; 48) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 9243-2 ; 49) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 9243-2 ; 50) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 11020 ; 51) PN21OTMCD, UDI-DI: 10197106282472(each), 50197106282470(case), Lot Number: 9243-2 ; 52) PN33CRMYB, UDI-DI: 10197106340240(each), 50197106340248(case), Lot Number: 7784-1 ; 53) PN33CRMYB, UDI-DI: 10197106340240(each), 50197106340248(case), Lot Number: 9243-1 ; 54) PN33CRMYB, UDI-DI: 10197106340240(each), 50197106340248(case), Lot Number: 9243-1 ; 55) PN36NBCHB, UDI-DI: 10197106225400(each), 50197106225408(case), Lot Number: 14039 ; 56) PN36NBCHB, UDI-DI: 10197106225400(each), 50197106225408(case), Lot Number: 14039 ; 57) PN40CKC27, UDI-DI: 10198956266001(each), 50198956266009(case), Lot Number: 15463 ; 58) PN40CKC27, UDI-DI: 10198956266001(each), 50198956266009(case), Lot Number: 12206 ; 59) PN40CKC28, UDI-DI: 10198956278189(each), 50198956278187(case), Lot Number: 15463-5 ; 60) PN40CKC28, UDI-DI: 10198956278189(each), 50198956278187(case), Lot Number: 15463-1 ; 61) PN40CKC28, UDI-DI: 10198956278189(each), 50198956278187(case), Lot Number: 12206 ; 62) PN40CKC29, UDI-DI: 10198956435377(each), 50198956435375(case), Lot Number: 15463-6 ; 63) PN40CKC29, UDI-DI: 10198956435377(each), 50198956435375(case), Lot Number: 15463-4 ; 64) PN40CKC29, UDI-DI: 10198956435377(each), 50198956435375(case), Lot Number: 15463 ; 65) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 7044 ; 66) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 7044 ; 67) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 6865 ; 68) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160-1 ; 69) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 9243 ; 70) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160-2 ; 71) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 9243 ; 72) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 2390 ; 73) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 2083366 ; 74) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 93845 ; 75) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 93845 ; 76) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 1103085 ; 77) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4869 ; 78) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4730 ; 79) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 7390 ; 80) PN40CKCFC, UDI-DI: 7784 (each), 10195594679934(case), Lot Number: 50195594679932; 81) PN40CKCFC, UDI-DI: 8160 (each), 10195594679934(case), Lot Number: 50195594679932; 82) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8808 ; 83) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 9243 ; 84) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 2390 ; 85) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 3747 ; 86) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 596378 ; 87) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4366 ; 88) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4730 ; 89) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 4869-2 ; 90) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 7044 ; 91) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160 ; 92) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160 ; 93) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8160 ; 94) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 8808-2 ; 95) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 94970 ; 96) PN40CKCFC, UDI-DI: 10195594679934(each), 50195594679932(case), Lot Number: 3024 ; 97) PNCGLLBMB, UDI-DI: 10195594635459(each), 50195594635457(case), Lot Number: 3916-3 ; 98) PNCGLLBMB, UDI-DI: 10195594635459(each), 50195594635457(case), Lot Number: 1726 ; 99) PNCGLLBMB, UDI-DI: 10195594635459(each), 50195594635457(case), Lot Number: 2390 ; 100) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 4730 ; 101) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 7390-1 ; 102) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 7784-1 ; 103) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 7784-2 ; 104) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 7784-2 ; 105) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 8160-2 ; 106) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 9243-1 ; 107) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 9243-2 ; 108) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 10339 ; 109) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 10392 ; 110) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 10586 ; 111) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 12206 ; 112) PNCGLLBMC, UDI-DI: 10197106170113(each), 50197106170111(case), Lot Number: 13289 ; 113) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 9243 ; 114) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 9243-1 ; 115) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 9243-2 ; 116) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 11020 ; 117) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 9243-1 ; 118) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 12206 ; 119) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 11020 ; 120) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 13289 ; 121) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 13673 ; 122) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 14813 ; 123) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15192-1 ; 124) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15192-1 ; 125) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463 ; 126) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-2 ; 127) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-4 ; 128) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-5 ; 129) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-6 ; 130) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-6 ; 131) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 15463-7 ; 132) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 3747 ; 133) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 3916-1 ; 134) SBA73BPGCA, UDI-DI: 10888439874891(each), 50888439874899(case), Lot Number: 3916-3 ; 135) SBA73FFKW9, UDI-DI: 10197106535608(each), 50197106535606(case), Lot Number: 9243-1 ; 136) SBA95BMHH6, UDI-DI: 10197106912904(each), 50197106912902(case), Lot Number: 13673 ; 137) SBA95BMHH7, UDI-DI: 10198956018662(each), 50198956018660(case), Lot Number: 1... |
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
US Nationwide. Canada.
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
- Aug 19, 2026
- Recall initiation date
- Jul 14, 2026
- Center classification date
- Aug 13, 2026
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.