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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Convenience Kits

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 Class 2 Device Recall Medline Convenience Kitssee related information
Date Initiated by FirmJanuary 07, 2026
Date PostedFebruary 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1394-2026
Recall Event ID 98329
Product Classification Ear, nose, and throat surgical tray - Product Code OGR
ProductMedline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069I; 3) HEAD & NECK CDS-LF, Model Number: CDS983782C; 4) BAPTIST FLOYD BRONCHOSCOPY, Model Number: DYKE1456D; 5) BRONCHOSCOPY SETUP KIT, Model Number: DYKE1955; 6) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156; 7) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156A; 8) KIT ENT HEAD AND NECK GENERIC, Model Number: DYKMBNDL156B; 9) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174; 10) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174A; 11) KIT ENT LARYNGECTOMY, Model Number: DYKMBNDL174B; 12) KIT PEDS HEAD AND NECK, Model Number: DYKMBNDL196; 13) KIT OMF LEFORTE, Model Number: DYKMBNDL1A; 14) KIT OMF LEFORTE, Model Number: DYKMBNDL1B; 15) KIT OMF LEFORTE, Model Number: DYKMBNDL1C; 16) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32; 17) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32A; 18) KIT ENT ENDOSINUS GENERIC, Model Number: DYKMBNDL32B; 19) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66A; 20) KIT GEN SURG THYROIDECTOMY, Model Number: DYKMBNDL66B; 21) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88A; 22) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88B; 23) KIT GEN SURG EXCISION THYROID, Model Number: DYKMBNDL88C; 24) KIT GEN SURG LAP VENTRA, Model Number: DYKMBNDL96C; 25) MINOR ENT PACK, Model Number: DYNJ01831I; 26) ENT BASIC PACK-LF, Model Number: DYNJ0387711F; 27) D AND C PACK-LF, Model Number: DYNJ0855090P; 28) CSS SINUS PACK, Model Number: DYNJ17005I; 29) CSS HEAD & NECK PACK, Model Number: DYNJ26780I; 30) NASALPLASTY #61-RF, Model Number: DYNJ27320V; 31) MASTOID PACK-WINTER PARK-LF, Model Number: DYNJ32060C; 32) T&A PACK, Model Number: DYNJ32809I; 33) HEAD AND NECK PACK, Model Number: DYNJ41169; 34) SIMPLE NECK DISSECTION, Model Number: DYNJ47481C; 35) ENT PACK, Model Number: DYNJ47882F; 36) ENT PACK, Model Number: DYNJ48401C; 37) ENT PACK, Model Number: DYNJ51934A; 38) PK,ORTHO-EXTREMITY-LOSROBLES, Model Number: DYNJ52916A; 39) HEAD & NECK PACK, Model Number: DYNJ54964A; 40) HEAD & NECK PACK, Model Number: DYNJ54964B; 41) ENT - MINOR ENT PACK-LF, Model Number: DYNJ56840B; 42) GLENNON HEAD AND NECK PACK-LF, Model Number: DYNJ57200C; 43) ENT PACK, Model Number: DYNJ57688F; 44) RF T AND A PACK, Model Number: DYNJ61393A; 45) T & A PACK, Model Number: DYNJ61935D; 46) ENT PACK, Model Number: DYNJ62093B; 47) ENT PACK, Model Number: DYNJ64024B; 48) OSCLJ HEAD AND NECK PACK, Model Number: DYNJ66509A; 49) HEAD AND NECK PACK, Model Number: DYNJ67208; 50) HEAD & NECK PACK, Model Number: DYNJ67328B; 51) PEDS HEAD AND NECK PACK, Model Number: DYNJ69746B; 52) NASAL PACK, Model Number: DYNJ81280A; 53) ENT-PLASTICS PACK, Model Number: DYNJ84258A; 54) ENT-PLASTICS PACK, Model Number: DYNJ84258B; 55) HEAD & NECK PACK, Model Number: DYNJ85078A; 56) ENT PACK, Model Number: DYNJ86194A; 57) EENT PACK, Model Number: DYNJ86235; 58) ENT PACK, Model Number: DYNJ87378; 59) ENT PACK, Model Number: DYNJ87378A; 60) ENT PACK, Model Number: DYNJ87378D; 61) ENT SPLIT PACK, Model Number: DYNJ87451; 62) ENT SINUS PACK, Model Number: DYNJ88498; 63) NASAL, Model Number: DYNJ902993F; 64) ENDO SINUS-MIDTOWN, Model Number: DYNJ905866; 65) T A, Model Number: DYNJ906292B; 66) THYROID, Model Number: DYNJ906841A; 67) THYROID - SMH AMB, Model Number: DYNJ907739B; 68) ENT, Model Number: DYNJ911623; 69) HEAD AND NECK PACK, Model Number: DYNJT5739; 70) RO MEDIASTINAL PACK-LF, Model Number: PHS393087007C
Code Information 1) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21IBD399; 2) CDS983069G, UDI-DI: 10193489923926(each), 40193489923927(case), Lot Number: 21HBO921; 3) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22JBW315; 4) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22GBE731; 5) CDS983069I, UDI-DI: 10195327071868(each), 40195327071869(case), Lot Number: 22FBX804; 6) CDS983782C, UDI-DI: 10193489592047(each), 40193489592048(case), Lot Number: 21DKA756; 7) DYKE1456D, UDI-DI: 10195327639938(each), 40195327639939(case), Lot Number: 24CBK289; 8) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25HLA345; 9) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25FLA904; 10) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25DLB145; 11) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 25CLB002; 12) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24DLA606; 13) DYKE1955, UDI-DI: 10195327539832(each), 40195327539833(case), Lot Number: 24ALA266; 14) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBS478; 15) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21FBO537; 16) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21DBJ855; 17) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21CBD340; 18) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21BBG062; 19) DYKMBNDL156, UDI-DI: 10193489478242(each), 40193489478243(case), Lot Number: 21ABK323; 20) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22GBH498; 21) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22FBT038; 22) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22EBS812; 23) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22DBL428; 24) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22CBX230; 25) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22BBA231; 26) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 22ABG015; 27) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBB014; 28) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21JBA009; 29) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21IBP624; 30) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21HBF494; 31) DYKMBNDL156A, UDI-DI: 10193489951912(each), 40193489951913(case), Lot Number: 21GBE737; 32) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25GBX739; 33) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25EBH975; 34) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25DBQ008; 35) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25BBM402; 36) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 25ABK769; 37) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24KBJ157; 38) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24HBU706; 39) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBR935; 40) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24GBD477; 41) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24EBF125; 42) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24DBV609; 43) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 24ABL113; 44) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBT911; 45) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23JBQ487; 46) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBV381; 47) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23HBT877; 48) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23FBG212; 49) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23EBS366; 50) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23DBM060; 51) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 23ABQ109; 52) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22KBH786; 53) DYKMBNDL156B, UDI-DI: 10195327240363(each), 40195327240364(case), Lot Number: 22IBU647; 54) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21FBQ554; 55) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21BBP836; 56) DYKMBNDL174, UDI-DI: 10193489478334(each), 40193489478335(case), Lot Number: 21ABH824; 57) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22EBO543; 58) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 22BBS429; 59) DYKMBNDL174A, UDI-DI: 10193489951882(each), 40193489951883(case), Lot Number: 21LBY299; 60) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 25LBM606; 61) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24EBP260; 62) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24DBB691; 63) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 24CBA389; 64) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23JBN238; 65) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 23ABH675; 66) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22LBI002; 67) DYKMBNDL174B, UDI-DI: 10195327240370(each), 40195327240371(case), Lot Number: 22KBK464; 68) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBT411; 69) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBS041; 70) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBM511; 71) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBH559; 72) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21CBF521; 73) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21BBG851; 74) DYKMBNDL196, UDI-DI: 10193489479393(each), 40193489479394(case), Lot Number: 21ABP337; 75) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 23BLA884; 76) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22KLA452; 77) DYKMBNDL1A, UDI-DI: 10195327245832(each), 40195327245833(case), Lot Number: 22JLB001; 78) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA924; 79) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25FLA791; 80) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25DLA251; 81) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25CLA312; 82) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 25BLA837; 83) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24JLA055; 84) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24ILA560; 85) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLB156; 86) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24HLA924; 87) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24GLA055; 88) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 24FLA349; 89) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23LLA422; 90) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23KLA620; 91) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23JLA058; 92) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23ILA756; 93) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23HLA624; 94) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23DLA495; 95) DYKMBNDL1B, UDI-DI: 10195327352738(each), 40195327352739(case), Lot Number: 23CLA769; 96) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA386; 97) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25ILA035; 98) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA843; 99) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA232; 100) DYKMBNDL1C, UDI-DI: 10198459448591(each), 40198459448592(case), Lot Number: 25HLA179; 101) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21FBT798; 102) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21EBM706; 103) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21DBK216; 104) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21CBS031; 105) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21BBL111; 106) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ985; 107) DYKMBNDL32, UDI-DI: 10193489478723(each), 40193489478724(case), Lot Number: 21ABJ862; 108) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22HBP925; 109) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBQ602; 110) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22GBF522; 111) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22FBE193; 112) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBQ053; 113) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 22EBO633; 114) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21JBJ743; 115) DYKMBNDL32A, UDI-DI: 10193489952018(each), 40193489952019(case), Lot Number: 21IBD784; 116) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBP188; 117) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24GBC830; 118) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24EBU213; 119) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24DBU451; 120) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24CBR483; 121) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABK306; 122) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 24ABH039; 123) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23LBP166; 124) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23IBA611; 125) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBX217; 126) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23HBH678; 127) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23FBP266; 128) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBT500; 129) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23EBB247; 130) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23DBP706; 131) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 23BBS356; 132) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case).Lot Number: 22JBW957; 133) DYKMBNDL32B, UDI-DI: 10195327240325(each), 40195327240326(case), Lot Number: 22IBL167; 134) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24DBD514; 135) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24CBD159; 136) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 24BBT350; 137) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 23LBF184; 138) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22LBN128; 139) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22JBQ673; 140) DYKMBNDL66A, UDI-DI: 10195327240349(each), 40195327240340(case), Lot Number: 22JBG017; 141) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25LBI754; 142) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25JBF754; 143) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25CBR258; 144) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 25ABH117; 145) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24LBT153; 146) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24KBT017; 147) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24IBO509; 148) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24HBH734; 149) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24FBG015; 150) DYKMBNDL66B, UDI-DI: 10198459000607(each), 40198459000608(case), Lot Number: 24DBR155; 151) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23CBN843; 152) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23CBJ801; 153) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 23ABK217; 154) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22LBR829; 155) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22JBW066; 156) DYKMBNDL88A, UDI-DI: 10195327240400(each), 40195327240401(case), Lot Number: 22JBD610; 157) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25FBT988; 158) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25EBU506; 159) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25EBK536; 160) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25CBI877; 161) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25ABS392; 162) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 25ABH118; 163) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24JBX567; 164) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24JBL602; 165) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24GBU190; 166) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24GBN944; 167) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24EBU598; 168) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24EBF126; 169) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24DBS395; 170) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24BBL266; 171) DYKMBNDL88B, UDI-DI: 10195327633691(each), 40195327633692(case), Lot Number: 24BBJ842; 172) DYKMBNDL88C, UDI-DI: 10198459584886(each), 40198459584887(case), Lot Number: 25LBP011; 173) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 25GBG516; 174) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24KBA441; 175) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24IBQ080; 176) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24HBN645; 177) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24HBJ497; 178) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24GBH580; 179) DYKMBNDL96C, UDI-DI: 10198459000782(each), 40198459000783(case), Lot Number: 24DBR908; 180) DYNJ01831I, UDI-DI: 10889942572502(each), 40889942572503(case), Lot Number: 21EMA909; 181) DYNJ0387711F, UDI-DI: 10198459005893(each), 40198459005894(case), Lot Number: 24HMA304; 182) DYNJ0855090P, UDI-DI: 10198459605826(each), 40198459605827(case), Lot Number: 25LMA083; 183) DYNJ17005I, UDI-DI: 10193489241860(each), 40193489241861(case), Lot Number: 23HBV662; 184) DYNJ26780I, UDI-DI: 10193489238822(each), 40193489238823(case), Lot Number: 23GBP197; 185) DYNJ27320V, UDI-DI: 10195327104719(each), 40195327104710(case), Lot Number: 22LBQ654; 186) DYNJ32060C, UDI-DI: 10884389637265(each), 40884389637266(case), Lot Number: 22LBS348; 187) DYNJ32809I, UDI-DI: 10193489448795(each), 40193489448796(case), Lot Number: 22IBP091; 188) DYNJ41169, UDI-DI: 10884389906699(each), 40884389906690(case), Lot Number: 22LBR515; 189) DYNJ47481C, UDI-DI: 10889942544028(each), 40889942544029(case), Lot Number: 21BBP023; 190) DYNJ47882F, UDI-DI: 10195327319472(each), 40195327319473(case), Lot Number: 23HME434; 191) DYNJ48401C, UDI-DI: 10198459175749(each), 40198459175740(case), Lot Number: 25ABD063; 192) DYNJ51934A, UDI-DI: 10193489584776(each), 40193489584777(case), Lot Number: 23HMG725; 193) DYNJ52916A, UDI-DI: 10195327311735(each), 40195327311736(case), Lot Number: 24GMK024; 194) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25DBB366; 195) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 25BBM674; 196) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 24LBN788; 197) DYNJ54964A, UDI-DI: 10198459033483(each), 40198459033484(case), Lot Number: 24IBV894; 198) DYNJ54964B, UDI-DI: 10198459428814(each), 40198459428815(case), Lot Number: 25KBH303; 199) DYNJ54964B, UDI-DI: 10198459428814(each), 40198459428815(case), Lot Number: 25HBR203; 200) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 22GBJ777; 201) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 21IBQ699; 202) DYNJ56840B, UDI-DI: 10193489416077(each), 40193489416078(case), Lot Number: 21IBQ696; 203) DYNJ57200C, UDI-DI: 10198459306754(each), 40198459306755(case), Lot Number: 25EMA242; 204) DYNJ57688F, UDI-DI: 10195327034610(each), 40195327034611(case), Lot Number: 22HMH769; 205) DYNJ61393A, UDI-DI: 10193489444179(each), 40193489444170(case), Lot Number: 23CMB523; 206) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 24BBK459; 207) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 24BBI869; 208) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 23LBP950; 209) DYNJ61935D, UDI-DI: 10195327453336(each), 40195327453337(case), Lot Number: 23HBC470; 210) DYNJ62093B, UDI-DI: 10193489969351(each), 40193489969352(case), Lot Number: 23ABE410; 211) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24KBS794; 212) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24HBO119; 213) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24EBS530; 214) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24DBV691; 215) DYNJ64024B, UDI-DI: 10195327556617(each), 40195327556618(case), Lot Number: 24ABK239; 216) DYNJ66509A, UDI-DI: 10193489462708(each), 40193489462709(case), Lot Number: 24HMA316; 217) DYNJ67208, UDI-DI: 10193489391671(each), 40193489391672(case), Lot Number: 20XBA769; 218) DYNJ67328B, UDI-DI: 10195327271503(each), 40195327271504(case), Lot Number: 23HMD036; 219) DYNJ69746B, UDI-DI: 10195327475222(each), 40195327475223(case), Lot Number: 24JLA247; 220) DYNJ81280A, UDI-DI: 10195327491284(each), 40195327491285(case), Lot Number: 25LME467; 221) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24HBK264; 222) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24DBR594; 223) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24CBI987; 224) DYNJ84258A, UDI-DI: 10195327650742(each), 40195327650743(case), Lot Number: 24CBF775; 225) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25FBL492; 226) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 25EBG049; 227) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 24IBP146; 228) DYNJ84258B, UDI-DI: 10198459117985(each), 40198459117986(case), Lot Number: 24IBD271; 229) DYNJ85078A, UDI-DI: 10195327532543(each), 40195327532544(case), Lot Number: 24HMA736; 230) DYNJ86194A, UDI-DI: 10195327682293(each), 40195327682294(case), Lot Number: 24DBN706; 231) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 25LMD475; 232) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24IBL260; 233) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24HBV552; 234) DYNJ86235, UDI-DI: 10195327606534(each), 40195327606535(case), Lot Number: 24CBG395; 235) DYNJ87378, UDI-DI: 10198459034787(each), 40198459034788(case), Lot Number: 24HMA738; 236) DYNJ87378, UDI-DI: 10198459034787(each), 40198459034788(case), Lot Number: 24GMG790; 237) DYNJ87378A, UDI-DI: 10198459186394(each), 40198459186395(case), Lot Number: 24KMI285; 238) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25JMI380; 239) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25IMC112; 240) DYNJ87378D, UDI-DI: 10198459467257(each), 40198459467258(case), Lot Number: 25IMA065; 241) DYNJ87451, UDI-DI: 10198459040283(each), 40198459040284(case), Lot Number: 24HBH452; 242) DYNJ88498, UDI-DI: 10198459166181(each), 40198459166182(case), Lot Number: 24KMF610; 243) DYNJ88498, UDI-DI: 10198459166181(each), 40198459166182(case), Lot Number: 24KMC641; 244) DYNJ902993F, UDI-DI: 10193489490817(each), 40193489490818(case), Lot Number: 23IMD509; 245) DYNJ902993F, UDI-DI: 10193489490817(each), 40193489490818(case), Lot Number: 23IMA480; 246) DYNJ905866, UDI-DI: 10193489547184(each), 40193489547185(case), Lot Number: 23CBW319; 247) DYNJ906292B, UDI-DI: 10193489877588(each), 40193489877589(case), Lot Number: 24CBI703; 248) DYNJ906292B, UDI-DI: 10193489877588(each), 40193489877589(case), Lot Number: 24BBV224; 249) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21HBN905; 250) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21GBR282; 251) DYNJ906841A, UDI-DI: 10193489392197(each), 40193489392198(case), Lot Number: 21GBG669; 252) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25ABP522; 253) DYNJ907739B, UDI-DI: 10195327671778(each), 40195327671779(case), Lot Number: 25ABE814; 254) DYNJ911623, UDI-DI: 10198459441097(each), 40198459441098(case), Lot Number: 25HBH612; 255) DYNJT5739, UDI-DI: 10198459499661(each), 40198459499662(case), Lot Number: 25IMF120; 256) PHS393087007C, UDI-DI: 10193489222777(each), 40193489222778(case), Lot Number: 21ADA448
FEI Number 1417592
Recalling Firm/
Manufacturer
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
866-359-1704
Manufacturer Reason
for Recall
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA Determined
Cause 2
Under Investigation by firm
ActionAn URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-003 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form,
Quantity in Commerce9051 units
DistributionWorldwide distribution - US Nationwide.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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