Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number:… — Class II medical device recall Z-0913-2025
Ongoing recall by Cardinal Health 200, LLC, reported 2025-01-22, distributed nationwide. Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
| Recall number | Z-0913-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2024-11-08 |
| Classified | 2025-01-15 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SA |
| Quantity | 512,786 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00885425162140, 10195594002442, 10195594004828, 10195594005184, 10195594005252, 10195594013622, 10195594014636, 10195594016821, 10195594017415, 10195594024031, 10195594025526, 10195594033941, 10195594038878, 10195594045043, 10195594054342, 10195594063238, 10195594064587, 10195594065607, 10195594067717, 10195594070663, 10195594076313, 10195594077310, 10195594079369, 10195594090142, 10195594094874 and 475 more |
| Lot numbers | 03480119X, 1036595, 1075581, 1079883, 1088650, 1119502, 1127940, 1210870, 1271519, 1306566, 14900809, 1722133, 18J2583, 18K2934, 18L3226, 1904061A, 19A0125, 19B0516, 19E1526, 19H2491, 19L3475, 20-1-3, 2001061A, 2027300664, 2032921264, 2100300664, 2106801264, 2114500864, 2120101364, 21J2884, 21K3110, 2204613564, 2211605064, 2224215364, 22D1239, 23F1430, 23J2297, 24-04, 24C0657, 252434 and 460 more |
| Model numbers | PE23NSMEA, PE23NSMEC, PE23SENLA, PE23SENLC, PE30EAGT6, PE30EAGT7, PE30EAGT8, PE30EAGT9, PE30EAGTB, PE30EAGTC, PE30EAGTD, PE35NSB10, PE35NSB11, PE35NSB12, PE35NSB13, PE35NSB14, PE35NSB15, PE35NSB16, PE35NSB17, PE35NSB18, PE35NSB19, PE35NSBL1, PE35NSBL2, PE35NSBL3, PE35NSBL4 and 475 more |
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 SINUS ENDO,HERMAN , Catalog Number: PEMHNSBH9; 61 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHP; 62 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHQ; 63 ) KIT,NASAL OR SINUS ENDO,HERMAN , Catalog Number: PEMHNSBHR; 64 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL011; 65 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL012; 66 ) KIT, NASAL SINUS PRESBYTERIAN , Catalog Number: PEV2CL01A; 67 ) KIT,NASAL SINUS ,PRESBYTERIAN , Catalog Number: PEV2CL102; 68 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL103; 69 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL104; 70 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL105; 71 ) KIT,NASAL SINUS , PRESBYTERIAN , Catalog Number: PEV2CL106; 72 ) KIT,NASAL SINUS , PRESBYTERIAN , C
Reason for recall
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0913-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.