Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD ...
FDA Device Recall #Z-1135-2025 — Class II — November 8, 2024
Recall Summary
| Recall Number | Z-1135-2025 |
| 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 | 793,785 total units |
Product Description
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP22 6) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP23 7) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP24 8) CHI STD SPINE OPTION 2, Catalog Number:CHIP99SP2D 9) KIT,LUMBAR LAMINECTOMY, Catalog Number:PN29LMFGA 10) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM4 11) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM5 12) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM6 13) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM7 14) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM8 15) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLM9 16) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMA 17) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMB 18) KIT, MAJOR SPINE, LUTHERAN, Catalog Number:PN29PSLMC 19) KIT, BACK, Catalog Number:PN33BPC10 20) KIT, BACK, Catalog Number:PN33BPC11 21) KIT, BACK, Catalog Number:PN33BPCR1 22) KIT, BACK, Catalog Number:PN33BPCR2 23) KIT, BACK, Catalog Number:PN33BPCR3 24) KIT, BACK, Catalog Number:PN33BPCR4 25) KIT, BACK, Catalog Number:PN33BPCR5 26) KIT, BACK, Catalog Number:PN33BPCR6 27) KIT, BACK, Catalog Number:PN33BPCR7 28) KIT, BACK, Catalog Number:PN33BPCR8 29) KIT, BACK, Catalog Number:PN33BPCR9 30) KIT, BACK, Catalog Number:PN33BPCRA 31) KIT, BACK, Catalog Number:PN33BPCRB 32) KIT, BACK, Catalog Number:PN33BPCRC 33) KIT, MAJOR SPINE, Catalog Number:PN33MSOCG 34) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU1 35) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOU2 36) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUA 37) KIT, SPINAL ACCESSORY JAMES, Catalog Number:PN33SAOUB 38) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUC 39) KIT, JAMES SPINAL ACCESSORY, Catalog Number:PN33SAOUD 40) KIT, LAMINECTOMY, Catalog Number:PN41LMMYA 41) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA1 42) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA2 43) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA3 44) KIT, MINOR SPINE LG MODULE, Catalog Number:PN69MSGA4 45) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU2 46) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU3 47) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU4 48) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU5 49) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU6 50) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAU7 51) KIT,ASLMC ORTHO CERVICAL PACK, Catalog Number:PNCGAPAUJ 52) KIT, SPINE, Catalog Number:PNCGKSPI1 53) KIT, ACDF, Catalog Number:PNMVASNL1 54) KIT, ACDF, Catalog Number:PNMVASNL2 55) KIT, ACDF, Catalog Number:PNMVASNLA 56) KIT, ACDF, Catalog Number:PNMVASNLB 57) KIT, ACDF, Catalog Number:PNMVASNLC 58) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL2 59) KIT, LAMINECTOMY, Catalog Number:PNMVLMNL3 60) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLA 61) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLB 62) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLC 63) KIT, LAMINECTOMY, Catalog Number:PNMVLMNLD 64) KIT, SPINE FUSION, Catalog Number:PNMVSF454 65) KIT, SPINE FUSION, Catalog Number:PNMVSF45A 66) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA1 67) KIT,CRANIOTOMY, Catalog Number:PNOCCRZA2 68) KIT,CRANIOTOMY, Catalog Number:PNOCCRZAA 69) KIT,LAMINECTOMY, Catalog Number:PNOCLAZA1 70) KIT,LAMINECTOMY, Catalog Number:PNOCLAZAA 71) KIT, LAMINECTOMY, Catalog Number:PNOCLAZAB 72) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH11 73) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH12 74) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH13 75) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH14 76) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPH15 77) SPINE, HUNTINGTON, Catalog Number:PNOCSPHTU 78) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTV 79) KIT, SPINE, HUNTINGTON, Catalog Number:PNOCSPHTW 80) KIT, ORTHO C
Reason for Recall
Potential for 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
1) CHIP99SP11, UDI-DI:10195594137595 (each) 50195594137593 (case), Lot Number: 5138229 ; 2) CHIP99SP12, UDI-DI:10195594268466 (each) 50195594268464 (case), Lot Number: 5324036 ; 3) CHIP99SP13, UDI-DI:10197106271377 (each) 50197106271375 (case), Lot Number: 6907769 ; 4) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7045815 ; 5) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280043 ; 6) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701891 ; 7) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701938 ; 8) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6986974 ; 9) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7005449 ; 10) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7055825 ; 11) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7160425 ; 12) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7260062 ; 13) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7280062 ; 14) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7287465 ; 15) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6485588 ; 16) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7331290 ; 17) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4218Z ; 18) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678H ; 19) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678J ; 20) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332809 ; 21) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4678P ; 22) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332837 ; 23) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 7332837 ; 24) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J4680D ; 25) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J53W07 ; 26) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J53W10 ; 27) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6049N ; 28) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6277R ; 29) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: N/A ; 30) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6277W ; 31) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6365T ; 32) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J72P49 ; 33) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J72P49 ; 34) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J82K97 ; 35) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: N/A ; 36) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J8123N ; 37) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J8393C ; 38) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J93M83 ; 39) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5372220 ; 40) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5530888 ; 41) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5530904 ; 42) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5631043 ; 43) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5664019 ; 44) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: J6049X ; 45) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5699520 ; 46) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5775787 ; 47) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 5775788 ; 48) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6025763 ; 49) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6022051 ; 50) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6264448 ; 51) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6183268 ; 52) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6411401 ; 53) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6485582 ; 54) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6560931 ; 55) CHIP99SP1E, UDI-DI:10888439373226 (each) 50888439373224 (case), Lot Number: 6701948 ; 56) CHIP99SP22, UDI-DI:10195594006723 (each) 50195594006721 (case), Lot Number: J96N37 ; 57) CHIP99SP23, UDI-DI:10195594158040 (each) 50195594158048 (case), Lot Number: 5138235 ; 58) CHIP99SP24, UDI-DI:10195594307745 (each) 50195594307743 (case), Lot Number: 5508040 ; 59) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7280043 ; 60) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6264449 ; 61) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6905474 ; 62) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7005424 ; 63) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7121998 ; 64) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6701940 ; 65) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7055833 ; 66) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7122072 ; 67) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7122098 ; 68) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7160425 ; 69) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7286183 ; 70) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7280044 ; 71) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7260072 ; 72) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7287471 ; 73) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7348991 ; 74) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4218Z ; 75) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 7332810 ; 76) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4678X ; 77) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4679T ; 78) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4950P ; 79) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J4950W ; 80) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J53W19 ; 81) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: N/A ; 82) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J6049M ; 83) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J6277P ; 84) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J68T51 ; 85) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J7412G ; 86) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J72P49 ; 87) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: PO962497 ; 88) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5530888 ; 89) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5530911 ; 90) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5631040 ; 91) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J6049Z ; 92) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: J53W15 ; 93) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5775787 ; 94) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5664021 ; 95) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6022055 ; 96) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6345502 ; 97) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 5530909 ; 98) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6563906 ; 99) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6563795 ; 100) CHIP99SP2D, UDI-DI:10888439373219 (each) 50888439373217 (case), Lot Number: 6687065 ; 101) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7280076 ; 102) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287537 ; 103) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287473 ; 104) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7331317 ; 105) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287463 ; 106) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7287534 ; 107) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7332810 ; 108) PN29LMFGA, UDI-DI:10197106544402 (each) 50197106544400 (case), Lot Number: 7332870 ; 109) PN29PSLM4, UDI-DI:10195594301002 (each) 50195594301000 (case), Lot Number: 5324048 ; 110) PN29PSLM5, UDI-DI:10195594592653 (each) 50195594592651 (case), Lot Number: 5664025 ; 111) PN29PSLM6, UDI-DI:10195594632403 (each) 50195594632401 (case), Lot Number: 5775787 ; 112) PN29PSLM7, UDI-DI:10195594728694 (each) 50195594728692 (case), Lot Number: 6025764 ; 113) PN29PSLM8, UDI-DI:10197106531891 (each) 50197106531899 (case), Lot Number: 7160479 ; 114) PN29PSLM9, UDI-DI:10197106567555 (each) 50197106567553 (case), Lot Number: 7280061 ; 115) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: J7267D ; 116) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5405610 ; 117) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5530908 ; 118) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5631042 ; 119) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: J6365M ; 120) PN29PSLMA, UDI-DI:10195594936990 (each) 50195594936998 (case), Lot Number: 5891291 ; 121) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6701938 ; 122) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6986974 ; 123) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 7005426 ; 124) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6264449 ; 125) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6485573 ; 126) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6563906 ; 127) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6568661 ; 128) PN29PSLMB, UDI-DI:10195594708320 (each) 50195594708328 (case), Lot Number: 6568661 ; 129) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7122097 ; 130) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7284052 ; 131) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7160478 ; 132) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7287472 ; 133) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7287463 ; 134) PN29PSLMC, UDI-DI:10197106429112 (each) 50197106429110 (case), Lot Number: 7332814 ; 135) PN33BPC10, UDI-DI:10197106682050 (each) 50197106682058 (case), Lot Number: 6485591 ; 136) PN33BPC10, UDI-DI:10197106682050 (each) 50197106682058 (case), Lot Number: 6485594 ; 137) PN33BPC11, UDI-DI:10197106717301 (each) 50197106717309 (case), Lot Number: 7332810 ; 138) PN33BPC11, UDI-DI:10197106717301 (each) 50197106717309 (case), Lot Number: 7331430 ; 139) PN33BPCR1, UDI-DI:10197106027066 (each) 50197106027064 (case), Lot Number: 6563905 ; 140) PN33BPCR1, UDI-DI:10197106027066 (each) 50197106027064 (case), Lot Number: 6345505 ; 141) PN33BPCR1, UDI-DI:10197106027066 (each) 50197106027064 (case), Lot Number: 6485593 ; 142) PN33BPCR2, UDI-DI:10197106132319 (each) 50197106132317 (case), Lot Number: 6687082 ; 143) PN33BPCR2, UDI-DI:10197106132319 (each) 50197106132317 (case), Lot Number: 6701946 ; 144) PN33BPCR2, UDI-DI:10197106132319 (each) 50197106132317 (case), Lot Number: 6701957 ; 145) PN33BPCR2, UDI-DI:10197106132319 (each) 50197106132317 (case), Lot Number: 6485596 ; 146) PN33BPCR3, UDI-DI:10197106255209 (each) 50197106255207 (case), Lot Number: 6905475 ; 147) PN33BPCR3, UDI-DI:10197106255209 (each) 50197106255207 (case), Lot Number: 6701848 ; 148) PN33BPCR4, UDI-DI:10197106505847 (each) 50197106505845 (case), Lot Number: 7260068 ; 149) PN33BPCR4, UDI-DI:10197106505847 (each) 50197106505845 (case), Lot Number: 7280083 ; 150) PN33BPCR5, UDI-DI:10197106531556 (each) 50197106531554 (case), Lot Number: 7160479 ; 151) PN33BPCR5, UDI-DI:10197106531556 (each) 50197106531554 (case), Lot Number: 6701986 ; 152) PN33BPCR6, UDI-DI:10197106570272 (each) 50197106570270 (case), Lot Number: 7280062 ; 153) PN33BPCR6, UDI-DI:10197106570272 (each) 50197106570270 (case), Lot Number: 7163141 ; 154) PN33BPCR7, UDI-DI:10197106587447 (each) 50197106587445 (case), Lot Number: 7287456 ; 155) PN33BPCR7, UDI-DI:10197106587447 (each) 50197106587445 (case), Lot Number: 6701984 ; 156) PN33BPCR8, UDI-DI:10197106635476 (each) 50197106635474 (case), Lot Number: 7287482 ; 157) PN33BPCR8, UDI-DI:10197106635476 (each) 50197106635474 (case), Lot Number: 7068414 ; 158) PN33BPCR9, UDI-DI:10197106665978 (each) 50197106665976 (case), Lot Number: 6485588 ; 159) PN33BPCR9, UDI-DI:10197106665978 (each) 50197106665976 (case), Lot Number: 7331296 ; 160) PN33BPCRA, UDI-DI:10195594899110 (each) 50195594899118 (case), Lot Number: 6563907 ; 161) PN33BPCRA, UDI-DI:10195594899110 (each) 50195594899118 (case), Lot Number: 6345505 ; 162) PN33BPCRA, UDI-DI:10195594899110 (each) 50195594899118 (case), Lot Number: 6485592 ; 163) PN33BPCRA, UDI-DI:10195594899110 (each) 50195594899118 (case), Lot Number: 6560932 ; 164) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6701894 ; 165) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6568663 ; 166) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7005445 ; 167) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6701984 ; 168) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6701940 ; 169) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6325766 ; 170) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7055833 ; 171) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 6701983 ; 172) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7260062 ; 173) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7068414 ; 174) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7068424 ; 175) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7055825 ; 176) PN33BPCRB, UDI-DI:10197106177808 (each) 50197106177806 (case), Lot Number: 7280083 ; 177) PN33BPCRC, UDI-DI:10197106706749 (each) 50197106706747 (case), Lot Number: 7045815 ; 178) PN33BPCRC, UDI-DI:10197106706749 (each) 50197106706747 (case), Lot Number: 7332850 ; 179) PN33BPCRC, UDI-DI:10197106706749 (each) 50197106706747 (case), Lot Number: 7332845 ; 180) PN33BPCRC, UDI-DI:10197106706749 (each) 50197106706747 (case), Lot Number: 7332849 ; 181) PN33MSOCG, UDI-DI:10197106384527 (each) 50197106384525 (case), Lot Number: 6560950 ; 182) PN33MSOCG, UDI-DI:10197106384527 (each) 50197106384525 (case), Lot Number: 7005493 ; 183) PN33SAOU1, UDI-DI:10195594811389 (each) 50195594811387 (case), Lot Number: 6133659 ; 184) PN33SAOU1, UDI-DI:10195594811389 (each) 50195594811387 (case), Lot Number: 5631066 ; 185) PN33SAOU2, UDI-DI:10197106035306 (each) 50197106035304 (case), Lot Number: 6416684 ; 186) PN33SAOU2, UDI-DI:10197106035306 (each) 50197106035304 (case), Lot Number: 6416700 ; 187) PN33SAOUA, UDI-DI:10195594510862 (each) 50195594510860 (case), Lot Number: 5664049 ; 188) PN33SAOUA, UDI-DI:10195594510862 (each) 50195594510860 (case), Lot Number: 5649225 ; 189) PN33SAOUA, UDI-DI:10195594510862 (each) 50195594510860 (case), Lot Number: 6232007 ; 190) PN33SAOUA, UDI-DI:10195594510862 (each) 50195594510860 (case), Lot Number: 6025778 ; 191) PN33SAOUB, UDI-DI:10197106090404 (each) 50197106090402 (case), Lot Number: 6470291 ; 192) PN33SAOUB, UDI-DI:10197106090404 (each) 50197106090402 (case), Lot Number: 6487896 ; 193) PN33SAOUC, UDI-DI:10197106159897 (each) 50197106159895 (case), Lot Number: 6568673 ; 194) PN33SAOUC, UDI-DI:10197106159897 (each) 50197106159895 (case), Lot Number: 6560942 ; 195) PN33SAOUC, UDI-DI:10197106159897 (each) 50197106159895 (case), Lot Number: 7269986 ; 196) PN33SAOUC, UDI-DI:10197106159897 (each) 50197106159895 (case), Lot Number: 7163118 ; 197) PN33SAOUD, UDI-DI:10197106557969 (each) 50197106557967 (case), Lot Number: 7331321 ; 198) PN33SAOUD, UDI-DI:10197106557969 (each) 50197106557967 (case), Lot Number: 7331476 ; 199) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332829 ; 200) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332807 ; 201) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332831 ; 202) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332837 ; 203) PN41LMMYA, UDI-DI:10197106698945 (each) 50197106698943 (case), Lot Number: 7332838 ; 204) PN69MSGA1, UDI-DI:10197106519899 (each) 50197106519897 (case), Lot Number: 7280036 ; 205) PN69MSGA1, UDI-DI:10197106519899 (each) 50197106519897 (case), Lot Number: 7287527 ; 206) PN69MSGA1, UDI-DI:10197106519899 (each) 50197106519897 (case), Lot Number: 7287561 ; 207) PN69MSGA2, UDI-DI:10197106634349 (each) 50197106634347 (case), Lot Number: 7287481 ; 208) PN69MSGA2, UDI-DI:10197106634349 (each) 50197106634347 (case), Lot Number: 7331319 ; 209) PN69MSGA2, UDI-DI:10197106634349 (each) 50197106634347 (case), Lot Number: 7332882 ; 210) PN69MSGA3, UDI-DI:10197106763889 (each) 50197106763887 (case), Lot Number: 7332838 ; 211) PN69MSGA3, UDI-DI:10197106763889 (each) 50197106763887 (case), Lot Number: 7349674 ; 212) PN69MSGA3, UDI-DI:10197106763889 (each) 50197106763887 (case), Lot Number: 7332890 ; 213) PN69MSGA4, UDI-DI:10197106803738 (each) 50197106803736 (case), Lot Number: 7280055 ; 214) PN69MSGA4, UDI-DI:10197106803738 (each) 50197106803736 (case), Lot Number: 6748353 ; 215) PN69MSGA4, UDI-DI:10197106803738 (each) 50197106803736 (case), Lot Number: 6779832 ; 216) PNCGAPAU2, UDI-DI:10888439953145 (each) 50888439953143 (case), Lot Number: J86N66 ; 217) PNCGAPAU3, UDI-DI:10195594025069 (each) 50195594025067 (case), Lot Number: J9699Z ; 218) PNCGAPAU4, UDI-DI:10195594099602 (each) 50195594099600 (case), Lot Number: 5135994 ; 219) PNCGAPAU5, UDI-DI:10195594250386 (each) 50195594250384 (case), Lot Number: J9699Y ; 220) PNCGAPAU6, UDI-DI:10195594366827 (each) 50195594366825 (case), Lot Number: 5405617 ; 221) PNCGAPAU7, UDI-DI:10195594674854 (each) 50195594674852 (case), Lot Number: 5631061 ; 222) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J37T97 ; 223) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J37T98 ; 224) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J4219R ; 225) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J46A82 ; 226) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J4877G ; 227) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J46A79 ; 228) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J8064R ; 229) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: J9424N ; 230) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: 5631062 ; 231) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: 5664047 ; 232) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: 5775802 ; 233) PNCGAPAUJ, UDI-DI:10887488852577 (each) 50887488852575 (case), Lot Number: 6022070 ; 234) PNCGKSPI1, UDI-DI:10195594894818 (each) 50195594894816 (case), Lot Number: 6485589 ; 235) PNCGKSPI1, UDI-DI:10195594894818 (each) 50195594894816 (case), Lot Number: 6364783 ; 236) PNMVASNL1, UDI-DI:10195594465988 (each) 50195594465986 (case), Lot Number: 5631035 ; 237) PNMVASNL1, UDI-DI:10195594465988 (each) 50195594465986 (case), Lot Number: 5565993 ; 238) PNMVASNL2, UDI-DI:10195594661670 (each) 50195594661678 (case), Lot Number: 109862 ; 239) PNMVASNL2, UDI-DI:10195594661670 (each) 50195594661678 (case), Lot Number: 5891288 ; 240) PNMVASNL2, UDI-DI:10195594661670 (each) 50195594661678 (case), Lot Number: 5140305 ; 241) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J53W17 ; 242) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J4951Y ; 243) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J53W13 ; 244) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J4951Y ; 245) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J6049Y ; 246) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J6366U ; 247) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: 219326 ; 248) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J7904N ; 249) PNMVASNLA, UDI-DI:10888439650112 (each) 50888439650110 (case), Lot Number: J7905A ; 250) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J68T47 ; 251) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J8671G ; 252) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 7752 ; 253) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J9602N ; 254) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J9601Y ; 255) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5138225 ; 256) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: J9601Z ; 257) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5324041 ; 258) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5140306 ; 259) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5324041 ; 260) PNMVASNLB, UDI-DI:10888439930696 (each) 50888439930694 (case), Lot Number: 5405623 ; 261) PNMVASNLC, UDI-DI:10195594471774 (each) 50195594471772 (case), Lot Number: 5631026 ; 262) PNMVASNLC, UDI-DI:10195594471774 (each) 50195594471772 (case), Lot Number: 5565993 ; 263) PNMVASNLC, UDI-DI:10195594471774 (each) 50195594471772 (case), Lot Number: 6025766 ; 264) PNMVASNLC, UDI-DI:10195594471774 (each) 50195594471772 (case), Lot Number: 6279856 ; 265) PNMVLMNL2, UDI-DI:10195594443641 (each) 50195594443649 (case), Lot Number: 5508057 ; 266) PNMVLMNL3, UDI-DI:10195594647353 (each) 50195594647351 (case), Lot Number: 5140305 ; 267) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J53W52 ; 268) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J5678J ; 269) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J6366U ; 270) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J79H50 ; 271) PNMVLMNLA, UDI-DI:10888439650174 (each) 50888439650172 (case), Lot Number: J8393G ; 272) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J7905A ; 273) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J6278P ; 274) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J6366Y ; 275) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J9601X ; 276) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: J9601Z ; 277) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: 5140303 ; 278) PNMVLMNLB, UDI-DI:10888439930702 (each) 50888439930700 (case), Lot Number: 7855 ; 279) PNMVLMNLC, UDI-DI:10195594224066 (each) 50195594224064 (case), Lot Number: 5140306 ; 280) PNMVLMNLC, UDI-DI:10195594224066 (each) 50195594224064 (case), Lot Number: 5405623 ; 281) PNMVLMNLC, UDI-DI:10195594224066 (each) 50195594224064 (case), Lot Number: 5478799 ; 282) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 5664093 ; 283) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 5664092 ; 284) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 6022074 ; 285) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 6279857 ; 286) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 6279859 ; 287) PNMVLMNLD, UDI-DI:10195594471828 (each) 50195594471826 (case), Lot Number: 6279860 ; 288) PNMVSF454, UDI-DI:10195594275891 (each) 50195594275899 (case), Lot Number: 5324034 ; 289) PNMVSF454, UDI-DI:10195594275891 (each) 50195594275899 (case), Lot Number: 5140306 ; 290) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J6785Z ; 291) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J8671G ; 292) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J96N35 ; 293) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J8393K ; 294) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5530904 ; 295) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5405624 ; 296) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5530901 ; 297) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5405625 ; 298) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5508042 ; 299) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5631064 ; 300) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: J6277X ; 301) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5649225 ; 302) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5664025 ; 303) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5664093 ; 304) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5775788 ; 305) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5858463 ; 306) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5891293 ; 307) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 5918338 ; 308) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6022060 ; 309) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6022074 ; 310) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6345497 ; 311) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6025781 ; 312) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6560926 ; 313) PNMVSF45A, UDI-DI:10888439970968 (each) 50888439970966 (case), Lot Number: 6279860 ; 314) PNOCCRZA1, UDI-DI:10197106554456 (each) 50197106554454 (case), Lot Number: 6701856 ; 315) PNOCCRZA2, UDI-DI:10197106573990 (each) 50197106573998 (case), Lot Number: 7287570 ; 316) PNOCCRZA2, UDI-DI:10197106573990 (each) 50197106573998 (case), Lot Number: 7266123 ; 317) PNOCCRZAA, UDI-DI:10197106307090 (each) 50197106307098 (case), Lot Number: 6702037 ; 318) PNOCCRZAA, UDI-DI:10197106307090 (each) 50197106307098 (case), Lot Number: 6788701 ; 319) PNOCCRZAA, UDI-DI:10197106307090 (each) 50197106307098 (case), Lot Number: 7331478 ; 320) PNOCCRZAA, UDI-DI:10197106307090 (each) 50197106307098 (case), Lot Number: 7331357 ; 321) PNOCLAZA1, UDI-DI:10197106576861 (each) 50197106576869 (case), Lot Number: 7287570 ; 322) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 6757045 ; 323) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 7005493 ; 324) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 6560950 ; 325) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 7160524 ; 326) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 7287570 ; 327) PNOCLAZAA, UDI-DI:10197106306895 (each) 50197106306893 (case), Lot Number: 7331477 ; 328) PNOCLAZAB, UDI-DI:10197106587201 (each) 50197106587209 (case), Lot Number: 7331478 ; 329) PNOCLAZAB, UDI-DI:10197106587201 (each) 50197106587209 (case), Lot Number: 7333440 ; 330) PNOCLAZAB, UDI-DI:1019710658720
Other Recalls from Cardinal Health 200, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1203-2026 | Class II | Chest Drainage Units and Accessories: Produc... | Dec 26, 2025 |
| Z-0897-2026 | Class II | ChemoPlus gowns: Product Code Product Descript... | Nov 12, 2025 |
| Z-0207-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
| Z-0208-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
| Z-0211-2026 | Class II | Salem Sump PVC Tubes: Product Code/Product N... | Sep 18, 2025 |
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.