Recall archive / FDA device enforcement
Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA... — FDA record Z-0913-2025
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: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLC; 5 ) KIT, EAR , Catalog Number: PE30EAGT6; 6 ) KIT, EAR , Catalog Number: PE30EAGT7; 7 ) KIT, EAR , Catalog Number: PE30EAGT8; 8 ) KIT, EAR , Catalog Number: PE30EAGT9; 9 ) KIT, EAR , Catalog Number: PE30EAGTB; 10 ) KIT, EAR , Catalog Number: PE30EAGTC; 11 ) KIT, EAR , Catalog Number: PE30EAGTD; 12 ) KIT, NASAL , Catalog Number: PE35NSB10; 13 ) KIT, NASAL , Catalog Number: PE35NSB11; 14 ) KIT, NASAL , Catalog Number: PE35NSB12; 15 ) KIT, NASAL , Catalog Number: PE35NSB13; 16 ) KIT, NASAL , Catalog Number: PE35NSB14; 17 ) KIT, NASAL , Catalog Number: PE35NSB15; 18 ) KIT, NASAL , Catalog Number: PE35NSB16; 19 ) KIT, NASAL , Catalog Number: PE35NSB17; 20 ) KIT, NASAL , Catalog Number: PE35NSB18; 21 ) KIT NASAL , Catalog Number: PE35NSB19; 22 ) KIT, NASAL , Catalog Number: PE35NSBL1; 23 ) KIT, NASAL , Catalog Number: PE35NSBL2; 24 ) KIT, NASAL , Catalog Number: PE35NSBL3; 25 ) KIT, NASAL , Catalog Number: PE35NSBL4; 26 ) KIT, NASAL , Catalog Number: PE35NSBL5; 27 ) KIT, NASAL , Catalog Number: PE35NSBL6; 28 ) KIT, NASAL , Catalog Number: PE35NSBL7; 29 ) KIT, NASAL , Catalog Number: PE35NSBL8; 30 ) KIT, NASAL , Catalog Number: PE35NSBL9; 31 ) KIT, NASAL , Catalog Number: PE35NSBLA; 32 ) KIT, NASAL , Catalog Number: PE35NSBLB; 33 ) KIT, NASAL , Catalog Number: PE35NSBLC; 34 ) KIT NASAL , Catalog Number: PE35NSBLD; 35 ) KIT, NASAL , Catalog Number: PE35NSBLF; 36 ) KIT, SINUS , Catalog Number: PE3ESKSG1; 37 ) KIT, SINUS , Catalog Number: PE3ESKSG2; 38 ) KIT, SINUS , Catalog Number: PE3ESKSGA; 39 ) KIT, SINUS , Catalog Number: PE3ESKSGB; 40 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU4; 41 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU5; 42 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU6; 43 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAU7; 44 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUH; 45 ) KIT,ASLMC NASAL PACK , Catalog Number: PECGNAAUI; 46 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNH3; 47 ) KIT, SEPTOPLASTY , Catalog Number: PEDHSPNHE; 48 ) KIT,ORP MAJOR EAR , Catalog Number: PEHDMJVCG; 49 ) KIT,ENT, SW , Catalog Number: PEMHETMHA; 50 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH1; 51 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMH2; 52 ) KIT,NASAL FENS, SW , Catalog Number: PEMHNFMHA; 53 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB10; 54 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSB11; 55 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH4; 56 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH5; 57 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH6; 58 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH7; 59 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH8; 60 ) KIT,NASAL OR SINU...
- Reason
- Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 512,786 total units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0913-2025
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 | Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 6928769 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7160527 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7163103 ; Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 7280105 ; Catalog Number PE23NSMEC, UDI/DI 10197106644829 (EA)50197106644827 (CS), Lot Number 7332911 ; Catalog Number PE23NSMEC, UDI/DI 10197106644829 (EA)50197106644827 (CS), Lot Number 7332915 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7160537 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7331341 ; Catalog Number PE23SENLA, UDI/DI 10197106543351 (EA)50197106543359 (CS), Lot Number 7332910 ; Catalog Number PE23SENLC, UDI/DI 10197106760956 (EA)50197106760954 (CS), Lot Number 7332917 ; Catalog Number PE30EAGT6, UDI/DI 10195594668167 (EA)50195594668165 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT7, UDI/DI 10195594725600 (EA)50195594725608 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT8, UDI/DI 10195594774950 (EA)50195594774958 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGT9, UDI/DI 10197106038192 (EA)50197106038190 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 22D1239 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 22D1239 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19A0125 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19A0125 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 18J2583 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19B0516 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19L3475 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 19E1526 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21J2884 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number XV2 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTB, UDI/DI 10887488998749 (EA)50887488998747 (CS), Lot Number 21K3110 ; Catalog Number PE30EAGTC, UDI/DI 10197106667309 (EA)50197106667307 (CS), Lot Number 24C0657 ; Catalog Number PE30EAGTD, UDI/DI 10197106733622 (EA)50197106733620 (CS), Lot Number 22D1239 ; Catalog Number PE35NSB10, UDI/DI 10195594540302 (EA)50195594540300 (CS), Lot Number 5664101 ; Catalog Number PE35NSB11, UDI/DI 10195594565909 (EA)50195594565907 (CS), Lot Number 5891306 ; Catalog Number PE35NSB12, UDI/DI 10197106027165 (EA)50197106027163 (CS), Lot Number 6025791 ; Catalog Number PE35NSB13, UDI/DI 10197106236963 (EA)50197106236961 (CS), Lot Number 6596396 ; Catalog Number PE35NSB14, UDI/DI 10197106285398 (EA)50197106285396 (CS), Lot Number 6487901 ; Catalog Number PE35NSB15, UDI/DI 10197106310618 (EA)50197106310616 (CS), Lot Number 6563988 ; Catalog Number PE35NSB16, UDI/DI 10197106322390 (EA)50197106322398 (CS), Lot Number 6788560 ; Catalog Number PE35NSB17, UDI/DI 10197106365939 (EA)50197106365937 (CS), Lot Number 6806113 ; Catalog Number PE35NSB18, UDI/DI 10197106418710 (EA)50197106418718 (CS), Lot Number 6806115 ; Catalog Number PE35NSB19, UDI/DI 10197106702574 (EA)50197106702572 (CS), Lot Number 7332911 ; Catalog Number PE35NSBL1, UDI/DI 10888439745771 (EA)50888439745779 (CS), Lot Number J3464F ; Catalog Number PE35NSBL2, UDI/DI 10888439759099 (EA)50888439759097 (CS), Lot Number J1896M ; Catalog Number PE35NSBL3, UDI/DI 10195594038878 (EA)50195594038876 (CS), Lot Number J8124C ; Catalog Number PE35NSBL4, UDI/DI 10195594120542 (EA)50195594120540 (CS), Lot Number J6050H ; Catalog Number PE35NSBL5, UDI/DI 10195594268176 (EA)50195594268174 (CS), Lot Number 5405628 ; Catalog Number PE35NSBL6, UDI/DI 10195594400392 (EA)50195594400390 (CS), Lot Number 5533334 ; Catalog Number PE35NSBL7, UDI/DI 10195594424862 (EA)50195594424860 (CS), Lot Number 5533336 ; Catalog Number PE35NSBL8, UDI/DI 10195594454494 (EA)50195594454492 (CS), Lot Number J6278U ; Catalog Number PE35NSBL9, UDI/DI 10195594492496 (EA)50195594492494 (CS), Lot Number 5664102 ; Catalog Number PE35NSBLA, UDI/DI 10888439647693 (EA)50888439647691 (CS), Lot Number J4952G ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J53W68 ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J5679K ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J8064Z ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J84K01 ; Catalog Number PE35NSBLB, UDI/DI 10888439767360 (EA)50888439767368 (CS), Lot Number J85W28 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6563989 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6914943 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6928764 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number J6050H ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5891311 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5891310 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5970334 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5631071 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 5891315 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6264565 ; Catalog Number PE35NSBLC, UDI/DI 10195594950866 (EA)50195594950864 (CS), Lot Number 6345522 ; Catalog Number PE35NSBLD, UDI/DI 10197106568828 (EA)50197106568826 (CS), Lot Number 7280105 ; Catalog Number PE35NSBLD, UDI/DI 10197106568828 (EA)50197106568826 (CS), Lot Number 7280106 ; Catalog Number PE35NSBLD, UDI/DI 10197106568828 (EA)50197106568826 (CS), Lot Number 7332906 ; Catalog Number PE35NSBLF, UDI/DI 10197106764299 (EA)50197106764297 (CS), Lot Number 7332913 ; Catalog Number PE3ESKSG1, UDI/DI 10195594388850 (EA)50195594388858 (CS), Lot Number 5533333 ; Catalog Number PE3ESKSG2, UDI/DI 10195594885793 (EA)50195594885791 (CS), Lot Number J6278R ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6560946 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number J85H45 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5135984 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5664102 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5664101 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891308 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891310 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891312 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 5891313 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6025787 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6025788 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6264569 ; Catalog Number PE3ESKSGA, UDI/DI 10888439947342 (EA)50888439947340 (CS), Lot Number 6345523 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 24-04 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332913 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332916 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6701853 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6806113 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6914942 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6928758 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 6928765 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7163033 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7163103 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7127056 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7287567 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7331341 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332910 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332913 ; Catalog Number PE3ESKSGB, UDI/DI 10197106268001 (EA)50197106268009 (CS), Lot Number 7332915 ; Catalog Number PECGNAAU4, UDI/DI 10195594396022 (EA)50195594396020 (CS), Lot Number 5618932 ; Catalog Number PECGNAAU5, UDI/DI 10195594483487 (EA)50195594483485 (CS), Lot Number 5631074 ; Catalog Number PECGNAAU6, UDI/DI 10195594566210 (EA)50195594566218 (CS), Lot Number 5891306 ; Catalog Number PECGNAAU7, UDI/DI 10195594698812 (EA)50195594698810 (CS), Lot Number 5891313 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J3464F ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J43U74 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J31U57 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J46C02 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J4952C ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J34J42 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J5679K ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J7963G ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J84K03 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J8671K ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number N/A ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J8692Y ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J8693A ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J86T83 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number J85W23 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5140346 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5140342 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5664102 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5876883 ; Catalog Number PECGNAAUH, UDI/DI 10887488810089 (EA)50887488810087 (CS), Lot Number 5891308 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7332916 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6560945 ; Cat... |
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
- Jan 22, 2025
- Recall initiation date
- Nov 8, 2024
- Center classification date
- Jan 15, 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.