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
FDA recall Z-0913-2025 — Cardinal Health 200, LLC is recalling 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 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
openFDA drug & device enforcement (recall) reports
FDA recall Z-0913-2025: Cardinal Health 200, LLC is recalling 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
The FDA logged enforcement record Z-0913-2025: Cardinal Health 200, LLC is voluntarily recalling 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.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-11-08. Affected lots/codes: 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 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6596397 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6914942 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6788562 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6788562 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928762 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928766 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928769 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928773 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7160537 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7163033 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928771 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928767 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 7332904 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6928770 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6025785 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 5631069 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6345521 ; Catalog Number PECGNAAUI, UDI/DI 10195594610050 (EA)50195594610058 (CS), Lot Number 6345522 ; Catalog Number PEDHSPNH3, UDI/DI 10888439697575 (EA)50888439697573 (CS), Lot Number J4952D ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J43U74 ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J30T39 ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J4952G ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J5678Z ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J5679F ; Catalog Number PEDHSPNHE, UDI/DI 10888439028553 (EA)50888439028551 (CS), Lot Number J5679M ; Catalog Number PEHDMJVCG, UDI/DI 10888439780963 (EA)50888439780961 (CS), Lot Number 19L3475 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6560944 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6701853 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6928757 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6928759 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7163033 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7280108 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7280109 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7287567 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332903 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332904 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332914 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 7332913 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 5631073 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 5891304 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 5891315 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6264570 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6345522 ; Catalog Number PEMHETMHA, UDI/DI 10195594542115 (EA)50195594542113 (CS), Lot Number 6560943 ; Catalog Number PEMHNFMH1, UDI/DI 10197106643495 (EA)50197106643493 (CS), Lot Number 7280109 ; Catalog Number PEMHNFMH2, UDI/DI 10197106679180 (EA)50197106679188 (CS), Lot Number 6914945 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6563989 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6928771 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 5664101 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 5891306 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 5891307 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number J6367H ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6264565 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6264566 ; Catalog Number PEMHNFMHA, UDI/DI 10195594542122 (EA)50195594542120 (CS), Lot Number 6487901 ; Catalog Number PEMHNSB10, UDI/DI 10197106092972 (EA)50197106092970 (CS), Lot Number 6487902 ; Catalog Number PEMHNSB11, UDI/DI 10197106417195 (EA)50197106417193 (CS), Lot Number 6806115 ; Catalog Number PEMHNSBH4, UDI/DI 10888439572605 (EA)50888439572603 (CS), Lot Number J3464F ; Catalog Number PEMHNSBH5, UDI/DI 10888439581683 (EA)50888439581681 (CS), Lot Number J3464F ; Catalog Number PEMHNSBH6, UDI/DI 10195594950057 (EA)50195594950055 (CS), Lot Number J8693A ; Catalog Number PEMHNSBH7, UDI/DI 10195594244033 (EA)50195594244031 (CS), Lot Number 5140342 ; Catalog Number PEMHNSBH8, UDI/DI 10195594520809 (EA)50195594520807 (CS), Lot Number 5618933 ; Catalog Number PEMHNSBH9, UDI/DI 10195594563059 (EA)50195594563057 (CS), Lot Number 5664101 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J46A99 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J4952D ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J53W68 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J6050D ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8064Z ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8124C ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8671K ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J8693A ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number N/A ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number J9602T ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number N/A ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number 5135984 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number 5618932 ; Catalog Number PEMHNSBHP, UDI/DI 10888439587081 (EA)50888439587089 (CS), Lot Number 5664098 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 5747232 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 5970333 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number J6278R ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 5631071 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 6025786 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number J6278R ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 6264567 ; Catalog Number PEMHNSBHQ, UDI/DI 10195594543518 (EA)50195594543516 (CS), Lot Number 6345522 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6560946 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6563990 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6702012 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6788561 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6928762 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7163033 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7163103 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7280106 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 6914945 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7287567 ; Catalog Number PEMHNSBHR, UDI/DI 10197106195307 (EA)50197106195305 (CS), Lot Number 7332918 ; Catalog Number PEV2CL011, UDI/DI 10197106673539 (EA)50197106673537 (CS), Lot Number 7163082 ; Catalog Number PEV2CL012, UDI/DI 10197106730485 (EA)50197106730483 (CS), Lot Number 7332913 ; Catalog Number PEV2CL01A, UDI/DI 10197106651711 (EA)50197106651719 (CS), Lot Number 7332909 ; Catalog Number PEV2CL102, UDI/DI 10195594414245 (EA)50195594414243 (CS), Lot Number 5533336 ; Catalog Number PEV2CL103, UDI/DI 10195594680145 (EA)50195594680143 (CS), Lot Number 5891305 ; Catalog Number PEV2CL104, UDI/DI 10195594711849 (EA)50195594711847 (CS), Lot Number J6367H ; Catalog Number PEV2CL105, UDI/DI 10195594745806 (EA)50195594745804 (CS), Lot Number 1271519 ; Catalog Number PEV2CL105, UDI/DI 10195594745806 (EA)50195594745804 (CS), Lot Number 5631071 ; Catalog Number PEV2CL106, UDI/DI 10195594779818 (EA)50195594779816 (CS), Lot Number 6025788 ; Catalog Number PEV2CL107, UDI/DI 10195594824129 (EA)50195594824127 (CS), Lot Number 5664103 ; Catalog Number PEV2CL108, UDI/DI 10195594876166 (EA)50195594876164 (CS), Lot Number J6278R ; Catalog Number PEV2CL109, UDI/DI 10197106306628 (EA)50197106306626 (CS), Lot Number 6701853 ; Catalog Number PEV2CL10O, UDI/DI 10887488813486 (EA)50887488813484 (CS), Lot Number J46A97 ; Catalog Number PEV2CL10P, UDI/DI 10888439619140 (EA)50888439619148 (CS), Lot Number J43U74 ; Catalog Number PEV2CL10P, UDI/DI 10888439619140 (EA)50888439619148 (CS), Lot Number J43U77 ; Catalog Number PEV2CL10P, UDI/DI 10888439619140 (EA)50888439619148 (CS), Lot Number J4952G ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J53W72 ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J53W68 ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J7704F ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J8123W ; Catalog Number PEV2CL10Q, UDI/DI 10888439687828 (EA)50888439687826 (CS), Lot Number J8124A ; Catalog Number PEV2CL10S, UDI/DI 10888439967456 (EA)50888439967454 (CS), Lot Number J6367G ; Catalog Number PEV2CL10S, UDI/DI 10888439967456 (EA)50888439967454 (CS), Lot Number J6367G ; Catalog Number PEV2CL10S, UDI/DI 10888439967456 (EA)50888439967454 (CS), Lot Number J86T82 ; Catalog Number PEV2CL10T, UDI/DI 10195594180713 (EA)50195594180711 (CS), Lot Number 5140355 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6563992 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number J1J0578Y ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5631074 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5631073 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5891307 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5891309 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 5891307 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6264568 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6345524 ; Catalog Number PEV2CL10U, UDI/DI 10195594455842 (EA)50195594455840 (CS), Lot Number 6563988 ; Catalog Number PEV2CL10V, UDI/DI 10197106246979 (EA)50197106246977 (CS), Lot Number 6702009 ; Catalog Number PEV2CL10V, UDI/DI 10197106246979 (EA)50197106246977 (CS), Lot Number 6914942 ; Catalog Number PEV2CL10W, UDI/DI 10197106425794 (EA)50197106425792 (CS), Lot Number 6788562 ; Catalog Number PEV2CL10W, UDI/DI 10197106425794 (EA)50197106425792 (CS), Lot Number 6914943 ; Catalog Number PEV2CL10X, UDI/DI 10197106484326 (EA)50197106484324 (CS), Lot Number 6928765 ; Catalog Number PEV2CL10X, UDI/DI 10197106484326 (EA)50197106484324 (CS), Lot Number 7160537 ; Catalog Number PEV2CL10Z, UDI/DI 10197106546789 (EA)50197106546787 (CS), Lot Number 7280105 ; Catalog Number PEV2CL10Z, UDI/DI 10197106546789 (EA)50197106546787 (CS), Lot Number 6928767 ; Catalog Number PEV2FSNYA, UDI/DI 10197106516225 (EA)50197106516223 (CS), Lot Number 7163033 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7349689 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7127056 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7280110 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7332903 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7332910 ; Catalog Number PEV2FSNYB, UDI/DI 10197106546550 (EA)50197106546558 (CS), Lot Number 7332916 ; Catalog Number PEV2OT10F, UDI/DI 10197106066669 (EA)50197106066667 (CS), Lot Number 6022128 ; Catalog Number PEV2OT10F, UDI/DI 10197106066669 (EA)50197106066667 (CS), Lot Number 6563990 ; Catalog Number PEV2OT10F, UDI/DI 10197106066669 (EA)50197106066667 (CS), Lot Number 6345522 ; Catalog Number PEV2OT10G, UDI/DI 10197106245163 (EA)50197106245161 (CS), Lot Number 6914944 ; Catalog Number PEV2OT10G, UDI/DI 10197106245163 (EA)50197106245161 (CS), Lot Number 6914945 ; Catalog Number PEV2OT10H, UDI/DI 10197106484418 (EA)50197106484416 (CS), Lot Number 6928765 ; Catalog Number PEV2OT10H, UDI/DI 10197106484418 (EA)50197106484416 (CS), Lot Number 7160527 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7280108 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7332917 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 6928771 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7280107 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 6928772 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7163082 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7332913 ; Catalog Number PEV2OT10I, UDI/DI 10197106547984 (EA)50197106547982 (CS), Lot Number 7332917 ; Catalog Number PEX4SSMNA, UDI/DI 10197106242599 (EA)50197106242597 (CS), Lot Number 6022130 ; Catalog Number PG35NSBL1, UDI/DI 10888439569360 (EA)50888439569368 (CS), Lot Number J3464G ; Catalog Number PG35NSBLA, UDI/DI 10888439559729 (EA)50888439559727 (CS), Lot Number J3987D ; Catalog Number PG35NSBLA, UDI/DI 10888439559729 (EA)50888439559727 (CS), Lot Number J43U77 ; Catalog Number PNVMESCH8, UDI/DI 10195594436070 (EA)50195594436078 (CS), Lot Number J70X17 ; Catalog Number PNVMESCH8, UDI/DI 10195594436070 (EA)50195594436078 (CS), Lot Number 5138232 ; Catalog Number PNVMESCH9, UDI/DI 10195594457419 (EA)50195594457417 (CS), Lot Number J6278U ; Catalog Number PNVMESCH9, UDI/DI 10195594457419 (EA)50195594457417 (CS), Lot Number 5530911 ; Catalog Number PQMHETMH2, UDI/DI 10195594927462 (EA)50195594927460 (CS), Lot Number J86T81 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J3987C ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J43U74 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J43U77 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J22M99 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J4952G ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J53W72 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J5679F ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J74A30 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J7963H ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J8393W ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J85W28 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 20-1-3 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J9602T ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number J86T82 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 5405627 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 5533336 ; Catalog Number PQMHETMHP, UDI/DI 10885425343683 (EA)50885425343681 (CS), Lot Number 5140343 ; Catalog Number PQMHNFMH2, UDI/DI 10195594939335 (EA)50195594939333 (CS), Lot Number J86T82 ; Catalog Number PQMHNFMH3, UDI/DI 10195594033941 (EA). A RECORDED FDA enforcement action (occurred=true).
openFDA drug & device enforcement (recall) reports — U.S. FDA
A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.
FDA classified recall Z-0913-2025 as Class II
The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
U.S. FDA recall classification (openFDA enforcement)
occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.
A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.
Ongoing — the recall is still being carried out.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.