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Cardinal Health Presource Kits: 1) CRANIOTOMY PACK, Catalog Number: 2NE69CNK12; 2) CHI STD NEUR...

FDA Device Recall #Z-0915-2025 — Class II — November 8, 2024

Recall Summary

Recall Number Z-0915-2025
Classification Class II — Moderate risk
Date Initiated November 8, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Cardinal Health 200, LLC
Location Waukegan, IL
Product Type Devices
Quantity 512,786 total units

Product Description

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 for Recall

Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia.

Lot / Code Information

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 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6498134 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6487916 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6563915 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 202202103 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6568673 ; Catalog Number CHIP99NC4D, UDI/DI 10888439373196 (EA)50888439373194 (CS), Lot Number 6702024 ; Catalog Number PE40OTJU2, UDI/DI 10888439713367 (EA)50888439713365 (CS), Lot Number J53W69 ; Catalog Number PE40OTJU2, UDI/DI 10888439713367 (EA)50888439713365 (CS), Lot Number J53W09 ; Catalog Number PE40OTJU2, UDI/DI 10888439713367 (EA)50888439713365 (CS), Lot Number J5678H ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J22M91 ; Catalog Number PE40OTJUE, UDI/DI 10888439341782 (EA)50888439341780 (CS), Lot Number J43U77 ; 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 ; 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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 ; 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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 ; 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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 ; 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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

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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