Medline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2) CHP COC...
FDA Device Recall #Z-1394-2026 — Class II — January 7, 2026
Recall Summary
| Recall Number | Z-1394-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 7, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medline Industries, LP |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 9051 units |
Product Description
Medline 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
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.
Distribution Pattern
Worldwide distribution - US Nationwide.
Lot / 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
Other Recalls from Medline Industries, LP
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2235-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2237-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2236-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2234-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
| Z-2232-2026 | Class I | Medline kits containing Huons Co. Bupivacaine H... | Apr 10, 2026 |
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.