FDA Device recall Z-0913-2025
Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG # by Cardinal Health 200, citing potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0913-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-08 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
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
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Identifiers
| code_info | Catalog Number PE23NSMEA, UDI/DI 10197106461914 (EA)50197106461912 (CS), Lot Number 6928769 ; Catalog Number P…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), |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0913-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.