Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10) KIT, CRANIOTOMY PMH , Catalog Number: PN08CPPCA; 11) KIT, NEURO , Catalog Number: PN11NEXX1; 12) KIT, NEURO , Catalog Number: PN11NEXXA; 13) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW2; 14) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW3; 15) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWG; 16) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWH; 17) KIT, MAJOR NEURO , Catalog Number: PN21MNEG1; 18) KIT, MAJOR NEURO , Catalog Number: PN21MNEG2; 19) KIT, MAJOR NEURO , Catalog Number: PN21MNEG3; 20) KIT, MAJOR NEURO , Catalog Number: PN21MNEG4; 21) KIT, MAJOR NEURO , Catalog Number: PN21MNEG5; 22) KIT, MAJOR NEURO , Catalog Number: PN21MNEGA; 23) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26) KIT,CRANIOTOMY , Catalog Number: PN23CFAH2; 27) KIT,CRANIOTOMY , Catalog Number: PN23CFAH3; 28) KIT,CRANIOTOMY , Catalog Number: PN23CFAH4; 29) KIT,CRANIOTOMY , Catalog Number: PN23CFAH5; 30) KIT,CRANIOTOMY , Catalog Number: PN23CFAH6; 31) KIT,CRANIOTOMY , Catalog Number: PN23CFAH7; 32) KIT,CRANIOTOMY , Catalog Number: PN23CFAHA; 33) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY734; 37) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY735; 38) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73D; 40) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73F; 41) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73G; 42) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73H; 43) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46) KIT,CRANIOTOMY,ANDERSON , Catalog Number: PN23CYAMY; 47) KIT,LAMINECTOMY RF , Catalog Number: PN23LMCVU; 48) KIT, NEURO , Catalog Number: PN23NKME1; 49) KIT, NEURO , Catalog Number: PN23NKMEA; 50) KIT, NEURO , Catalog Number: PN23NKMEB; 51) KIT, NEURO , Catalog Number: PN23NKMEC; 52) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA10; 53) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA11; 54) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA12; 55) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA13; 56) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM3; 57) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM4; 58) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM6; 59) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM7; 60) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM8; 61) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM9; 62) NEURO SPINE,ANDERSON,KIT , Catalog Number: PN23SPAMS; 63) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMV; 64) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMW; 65) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMX; 66) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMY; 67) KIT, CRANIOTOMY , Catalog Number: PN29CRA10; 68) KIT, CRANIOTOMY , Catalog Number: PN29CRA11; 69) KIT, CR
FDA recall Z-0915-2025 — Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10) KIT, CRANIOTOMY PMH , Catalog Number: PN08CPPCA; 11) KIT, NEURO , Catalog Number: PN11NEXX1; 12) KIT, NEURO , Catalog Number: PN11NEXXA; 13) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW2; 14) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW3; 15) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWG; 16) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWH; 17) KIT, MAJOR NEURO , Catalog Number: PN21MNEG1; 18) KIT, MAJOR NEURO , Catalog Number: PN21MNEG2; 19) KIT, MAJOR NEURO , Catalog Number: PN21MNEG3; 20) KIT, MAJOR NEURO , Catalog Number: PN21MNEG4; 21) KIT, MAJOR NEURO , Catalog Number: PN21MNEG5; 22) KIT, MAJOR NEURO , Catalog Number: PN21MNEGA; 23) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26) KIT,CRANIOTOMY , Catalog Number: PN23CFAH2; 27) KIT,CRANIOTOMY , Catalog Number: PN23CFAH3; 28) KIT,CRANIOTOMY , Catalog Number: PN23CFAH4; 29) KIT,CRANIOTOMY , Catalog Number: PN23CFAH5; 30) KIT,CRANIOTOMY , Catalog Number: PN23CFAH6; 31) KIT,CRANIOTOMY , Catalog Number: PN23CFAH7; 32) KIT,CRANIOTOMY , Catalog Number: PN23CFAHA; 33) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY734; 37) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY735; 38) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73D; 40) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73F; 41) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73G; 42) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73H; 43) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46) KIT,CRANIOTOMY,ANDERSON , Catalog Number: PN23CYAMY; 47) KIT,LAMINECTOMY RF , Catalog Number: PN23LMCVU; 48) KIT, NEURO , Catalog Number: PN23NKME1; 49) KIT, NEURO , Catalog Number: PN23NKMEA; 50) KIT, NEURO , Catalog Number: PN23NKMEB; 51) KIT, NEURO , Catalog Number: PN23NKMEC; 52) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA10; 53) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA11; 54) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA12; 55) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA13; 56) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM3; 57) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM4; 58) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM6; 59) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM7; 60) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM8; 61) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM9; 62) NEURO SPINE,ANDERSON,KIT , Catalog Number: PN23SPAMS; 63) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMV; 64) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMW; 65) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMX; 66) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMY; 67) KIT, CRANIOTOMY , Catalog Number: PN29CRA10; 68) KIT, CRANIOTOMY , Catalog Number: PN29CRA11; 69) KIT, CR (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-0915-2025: Cardinal Health 200, LLC is recalling Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10) KIT, CRANIOTOMY PMH , Catalog Number: PN08CPPCA; 11) KIT, NEURO , Catalog Number: PN11NEXX1; 12) KIT, NEURO , Catalog Number: PN11NEXXA; 13) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW2; 14) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW3; 15) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWG; 16) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWH; 17) KIT, MAJOR NEURO , Catalog Number: PN21MNEG1; 18) KIT, MAJOR NEURO , Catalog Number: PN21MNEG2; 19) KIT, MAJOR NEURO , Catalog Number: PN21MNEG3; 20) KIT, MAJOR NEURO , Catalog Number: PN21MNEG4; 21) KIT, MAJOR NEURO , Catalog Number: PN21MNEG5; 22) KIT, MAJOR NEURO , Catalog Number: PN21MNEGA; 23) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26) KIT,CRANIOTOMY , Catalog Number: PN23CFAH2; 27) KIT,CRANIOTOMY , Catalog Number: PN23CFAH3; 28) KIT,CRANIOTOMY , Catalog Number: PN23CFAH4; 29) KIT,CRANIOTOMY , Catalog Number: PN23CFAH5; 30) KIT,CRANIOTOMY , Catalog Number: PN23CFAH6; 31) KIT,CRANIOTOMY , Catalog Number: PN23CFAH7; 32) KIT,CRANIOTOMY , Catalog Number: PN23CFAHA; 33) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY734; 37) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY735; 38) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73D; 40) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73F; 41) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73G; 42) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73H; 43) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46) KIT,CRANIOTOMY,ANDERSON , Catalog Number: PN23CYAMY; 47) KIT,LAMINECTOMY RF , Catalog Number: PN23LMCVU; 48) KIT, NEURO , Catalog Number: PN23NKME1; 49) KIT, NEURO , Catalog Number: PN23NKMEA; 50) KIT, NEURO , Catalog Number: PN23NKMEB; 51) KIT, NEURO , Catalog Number: PN23NKMEC; 52) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA10; 53) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA11; 54) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA12; 55) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA13; 56) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM3; 57) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM4; 58) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM6; 59) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM7; 60) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM8; 61) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM9; 62) NEURO SPINE,ANDERSON,KIT , Catalog Number: PN23SPAMS; 63) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMV; 64) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMW; 65) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMX; 66) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMY; 67) KIT, CRANIOTOMY , Catalog Number: PN29CRA10; 68) KIT, CRANIOTOMY , Catalog Number: PN29CRA11; 69) KIT, CR
The FDA logged enforcement record Z-0915-2025: Cardinal Health 200, LLC is voluntarily recalling Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEURO CRANI OPT 4, Catalog Number: CHIP99NC42; 3) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC43; 4) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC44; 5) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC45; 6) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC46; 7) CHI STD NEURO CRANI OPT 4 , Catalog Number: CHIP99NC4D; 8) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJU2; 9) KIT, ENDOSCOPIC TRANSPHENODIAL , Catalog Number: PE40OTJUE; 10) KIT, CRANIOTOMY PMH , Catalog Number: PN08CPPCA; 11) KIT, NEURO , Catalog Number: PN11NEXX1; 12) KIT, NEURO , Catalog Number: PN11NEXXA; 13) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW2; 14) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBW3; 15) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWG; 16) KIT, NEUROSURGERY SKULL BASE , Catalog Number: PN13CRBWH; 17) KIT, MAJOR NEURO , Catalog Number: PN21MNEG1; 18) KIT, MAJOR NEURO , Catalog Number: PN21MNEG2; 19) KIT, MAJOR NEURO , Catalog Number: PN21MNEG3; 20) KIT, MAJOR NEURO , Catalog Number: PN21MNEG4; 21) KIT, MAJOR NEURO , Catalog Number: PN21MNEG5; 22) KIT, MAJOR NEURO , Catalog Number: PN21MNEGA; 23) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV2; 24) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCV3; 25) KIT,ANTERIOR CERVICAL FUSIO RF , Catalog Number: PN23ACCVU; 26) KIT,CRANIOTOMY , Catalog Number: PN23CFAH2; 27) KIT,CRANIOTOMY , Catalog Number: PN23CFAH3; 28) KIT,CRANIOTOMY , Catalog Number: PN23CFAH4; 29) KIT,CRANIOTOMY , Catalog Number: PN23CFAH5; 30) KIT,CRANIOTOMY , Catalog Number: PN23CFAH6; 31) KIT,CRANIOTOMY , Catalog Number: PN23CFAH7; 32) KIT,CRANIOTOMY , Catalog Number: PN23CFAHA; 33) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY731; 34) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY732; 35) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY733; 36) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY734; 37) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY735; 38) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CY73B; 39) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73D; 40) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73F; 41) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73G; 42) KIT ,CRANIOTOMY ANDERSON , Catalog Number: PN23CY73H; 43) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM1; 44) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM2; 45) KIT, CRANIOTOMY, ANDERSON , Catalog Number: PN23CYAM3; 46) KIT,CRANIOTOMY,ANDERSON , Catalog Number: PN23CYAMY; 47) KIT,LAMINECTOMY RF , Catalog Number: PN23LMCVU; 48) KIT, NEURO , Catalog Number: PN23NKME1; 49) KIT, NEURO , Catalog Number: PN23NKMEA; 50) KIT, NEURO , Catalog Number: PN23NKMEB; 51) KIT, NEURO , Catalog Number: PN23NKMEC; 52) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA10; 53) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA11; 54) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA12; 55) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPA13; 56) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM3; 57) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM4; 58) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM6; 59) KIT,NEURO SPINE,ANDERSON , Catalog Number: PN23SPAM7; 60) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM8; 61) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAM9; 62) NEURO SPINE,ANDERSON,KIT , Catalog Number: PN23SPAMS; 63) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMV; 64) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMW; 65) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMX; 66) KIT, NEURO SPINE, ANDERSON , Catalog Number: PN23SPAMY; 67) KIT, CRANIOTOMY , Catalog Number: PN29CRA10; 68) KIT, CRANIOTOMY , Catalog Number: PN29CRA11; 69) KIT, CR — 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 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5631070 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5530905 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5138271 ; Catalog Number 2NE69CNK12, UDI/DI 10195594412845 (EA)50195594412843 (CS), Lot Number 5533340 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136018 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136034 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136012 ; Catalog Number CHIP99NC42, UDI/DI 10195594124007 (EA)50195594124005 (CS), Lot Number 5136019 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5140342 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5324034 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5138327 ; Catalog Number CHIP99NC43, UDI/DI 10195594247867 (EA)50195594247865 (CS), Lot Number 5140378 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5478803 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5324048 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5138335 ; Catalog Number CHIP99NC44, UDI/DI 10195594272777 (EA)50195594272775 (CS), Lot Number 5405629 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5478804 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5138222 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5138325 ; Catalog Number CHIP99NC45, UDI/DI 10195594356156 (EA)50195594356154 (CS), Lot Number 5405629 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6701852 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6905475 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6748352 ; Catalog Number CHIP99NC46, UDI/DI 10197106243367 (EA)50197106243365 (CS), Lot Number 6702036 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6788561 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6928764 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7163104 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331341 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6928772 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7332910 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J3464F ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J34J41 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J37U06 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J43U77 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4952D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679H ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J6050D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J74A27 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679M ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7963H ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J8123Z ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J86T82 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631072 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631073 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5891310 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6025785 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6169297 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6345524 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6563988 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6907762 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6987090 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6806116 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7260066 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7163081 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7280113 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7260073 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7287536 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331351 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331283 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331323 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331347 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7287463 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7332858 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7269982 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7348991 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7331474 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 7280114 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4219A ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J37T95 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J30T06 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4219D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J3986R ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J37U14 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4678Z ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4219W ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J37U14 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4679H ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4877D ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J332169 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J46C05 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4951F ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4877T ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J4952R ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J6049Y ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J65K13 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679P ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J68T51 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J6786P ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679T ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J74A12 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J74A02 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J5679T ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J53W20 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J76N08 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7704J ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7962U ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J8045W ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7905H ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J8491U ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J8064U ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J7905J ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J84K06 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J70X14 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J70X08 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number J6368X ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631031 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5533309 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5533341 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631044 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5631062 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5664105 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5891284 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5891301 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 5565995 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6345502 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6133659 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6264573 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6485584 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6364783 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6487906 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6560930 ; 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Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J46C04 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J53W73 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J72P53 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J74A28 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8064Y ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8064Z ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8123Z ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8393U ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J43U62 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J37U05 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J4950H ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J46A95 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J4951G ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J53W54 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J53W20 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J5678J ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J74A17 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J5678J ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J74A18 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J79H50 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J82M03 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J79H48 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J79H49 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J79H50 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8670H ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J8393H ; Catalog Number PN08CPPCA, UDI/DI 10197106722909 (EA)50197106722907 (CS), Lot Number 7331310 ; Catalog Number PN11NEXX1, UDI/DI 10888439682618 (EA)50888439682616 (CS), Lot Number J46C04 ; Catalog Number PN11NEXX1, UDI/DI 10888439682618 (EA)50888439682616 (CS), Lot Number J4680A ; Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number J30T39 ; Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number J53W72 ; Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number J4949U ; Catalog Number PN11NEXXA, UDI/DI 10888439616828 (EA)50888439616826 (CS), Lot Number J53W13 ; Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number 18J2583 ; Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number J4952C ; Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number J4680A ; Catalog Number PN13CRBW2, UDI/DI 10888439679359 (EA)50888439679357 (CS), Lot Number J4952P ; Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number J6367F ; Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number 5138222 ; Catalog Number PN13CRBW3, UDI/DI 10195594375522 (EA)50195594375520 (CS), Lot Number 5533338 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number 18B0346 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J3464G ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number 19E1526 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J53W67 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J37T59 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J30T08 ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J6277M ; Catalog Number PN13CRBWG, UDI/DI 10887488542829 (EA)50887488542827 (CS), Lot Number J5679N ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 19L3475 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J5679H ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 19L3475 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J84K01 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 19L3475 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J84K02 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 5478803 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J82M01 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J7963U ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J82M01 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J7964A ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J8491U ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number J85W30 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 5324047 ; Catalog Number PN13CRBWH, UDI/DI 10888439885170 (EA)50888439885178 (CS), Lot Number 5405629 ; Catalog Number PN21MNEG1, UDI/DI 10195594202040 (EA)50195594202048 (CS), Lot Number 5140356 ; Catalog Number PN21MNEG1, UDI/DI 10195594202040 (EA)50195594202048 (CS), Lot Number 5138244 ; Catalog Number PN21MNEG2, UDI/DI 10195594276119 (EA)50195594276117 (CS), Lot Number 5478803 ; Catalog Number PN21MNEG2, UDI/DI 10195594276119 (EA)50195594276117 (CS), Lot Number 5324034 ; Catalog Number PN21MNEG3, UDI/DI 10195594327347 (EA)50195594327345 (CS), Lot Number J6278U ; Catalog Number PN21MNEG3, UDI/DI 10195594327347 (EA)50195594327345 (CS), Lot Number 5324040 ; Catalog Number PN21MNEG4, UDI/DI 10195594725136 (EA)50195594725134 (CS), Lot Number 5970334 ; Catalog Number PN21MNEG4, UDI/DI 10195594725136 (EA)50195594725134 (CS), Lot Number 6022053 ; Catalog Number PN21MNEG5, UDI/DI 10195594767822 (EA)50195594767820 (CS), Lot Number 6025786 ; Catalog Number PN21MNEG5, UDI/DI 10195594767822 (EA)50195594767820 (CS), Lot Number 6022060 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6563989 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6563988 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6788561 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6928762 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6928766 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6928764 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7280110 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7287567 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7332904 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7332909 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6928772 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J8123Z ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J84K02 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J86T83 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5533336 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5618932 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J6278U ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5664100 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5876883 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5888374 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6022130 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6345523 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6264447 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6986974 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7122004 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7260053 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7286184 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7260068 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7280048 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7287483 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7331285 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7332804 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 7332837 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J8393A ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J8491U ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J6366D ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5508039 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5530912 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 531025 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 5508041 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number J6277T ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6485589 ; Catalog Number PN21MNEGA, UDI/DI 10888439850901 (EA)50888439850909 (CS), Lot Number 6687082 ; Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number 18H2278 ; Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number J46C03 ; Catalog Number PN23ACCV2, UDI/DI 10888439756104 (EA)50888439756102 (CS), Lot Number J5678M ; Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number 18M3535 ; Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number J6050D ; Catalog Number PN23ACCV3, UDI/DI 10888439827965 (EA)50888439827963 (CS), Lot Number J6365Y ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number 18H2205 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J37U06 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number 18H2278 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J46A97 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number 18H2278 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J22M99 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number 19A0124 ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J4952M ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J3986K ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J4679C ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J4950G ; Catalog Number PN23ACCVU, UDI/DI 10888439245561 (EA)50888439245569 (CS), Lot Number J53W13 ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J30T25 ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J3987C ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J4678K ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J4219Z ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J46A89 ; Catalog Number PN23CFAH2, UDI/DI 10888439590920 (EA)50888439590928 (CS), Lot Number J37U13 ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J4219N ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J43U77 ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J4679P ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J43U77 ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J46A91 ; Catalog Number PN23CFAH3, UDI/DI 10888439637823 (EA)50888439637821 (CS), Lot Number J46C06 ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J46A88 ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J46A98 ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J4680D ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J4951X ; Catalog Number PN23CFAH4, UDI/DI 10888439661583 (EA)50888439661581 (CS), Lot Number J4952R ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J6366K ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number N/A ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J72P53 ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J72P50 ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J7498U ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number J5679T ; Catalog Number PN23CFAH5, UDI/DI 10888439827873 (EA)50888439827871 (CS), Lot Number N/A ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J7498G ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J74A30 ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J7609N ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J6366T ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number N/A ; Catalog Number PN23CFAH6, UDI/DI 10888439839180 (EA)50888439839188 (CS), Lot Number J74A38 ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J7498J ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J7704F ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J5678R ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J7704C ; Catalog Number PN23CFAH7, UDI/DI 10888439846720 (EA)50888439846728 (CS), Lot Number J74A38 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J4951H ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number N/A ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J53W68 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J53W37 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J5679D ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J7904W ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J7963H ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J8064Z ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J84J95 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J7963D ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J85W16 ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J8123Z ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number N/A ; Catalog Number PN23CFAHA, UDI/DI 10888439397895 (EA)50888439397893 (CS), Lot Number J8670X ; Catalog Number PN23CFAHA, UD. 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-0915-2025 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.