Medline Industries, LP: Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYS

Company / brand

Medline Industries, LP

Product

Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) D&C/HYSTEROSCOPY PACK, Model Number: DYNJ0547084O; 6) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 7) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 8) VAG HYST PACK, Model Number: DYNJ31344J; 9) VAG HYST PACK, Model Number: DYNJ31344K; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 12) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 13) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 14) LAVH PACK, Model Number: DYNJ36712F; 15) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 16) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 17) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 18) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 19) LAVH - N #668629 -N, Model Number: DYNJ58121C; 20) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 21) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 22) D AND C PACK, Model Number: DYNJ61282B; 23) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 24) PERI GYN, Model Number: DYNJ67708A; 25) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 26) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 27) ANORECTAL PACK, Model Number: DYNJ83560; 28) D&C CDS, Model Number: DYNJ902560I; 29) HYSTEROSCOPY, Model Number: DYNJ903327K; 30) HYSTEROSCOPY, Model Number: DYNJ903475I; 31) ROBOTIC HYST, Model Number: DYNJ903798G; 32) TLH KIT, Model Number: DYNJ908149; 33) LAVH TOTE, Model Number: DYNJ908340; 34) LAVH TOTE, Model Number: DYNJ908340A; 35) LAVH TOTE, Model Number: DYNJ908340B; 36) LAVH TOTE, Model Number: DYNJ908340D; 37) LAVH, Model Number: DYNJ908986; 38) LAVH, Model Number: DYNJ908986A; 39) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 40) LAVH GYN/ONC, Model Number: DYNJ910927; 41) VAG HYST PACK, Model Number: DYNJT3348; 42) LAVH PART B, Model Number: DYNJV0312G

Reason / hazard

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.

Classification

Class II

Status

Ongoing

Distribution / sold at

Worldwide - US Nationwide distribution.

Recall initiated

2026-01-07

Code info

1) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23GBE705; 2) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23HBY878; 3) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 23IBV204; 4) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24ABO363; 5) CDS984086I, UDI-DI: 10195327428006(each), 40195327428007(case), Lot Number: 24CBQ563; 6) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH028; 7) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH032; 8) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 22KBH451; 9) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBL440; 10) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23CBS135; 11) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBC116; 12) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23FBD256; 13) DYKMBNDL91A, UDI-DI: 10195327246891(each), 40195327246892(case), Lot Number: 23HBI773; 14) DYNJ0373807J, UDI-DI: 10193489942996(each), 40193489942997(case), Lot Number: 22EBC904; 15) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22HBV873; 16) DYNJ0373807K, UDI-DI: 10195327225681(each), 40195327225682(case), Lot Number: 22JBO175; 17) DYNJ0547084O, UDI-DI: 10193489888379(each), 40193489888370(case), Lot Number: 23KME941; 18) DYNJ21824R, UDI-DI: 10195327107758(each), 40195327107759(case), Lot Number: 23EBT744; 19) DYNJ27434R, UDI-DI: 10195327107727(each), 40195327107728(case), Lot Number: 23EBQ683; 20) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21ABP592; 21) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21CBJ513; 22) DYNJ31344J, UDI-DI: 10193489496604(each), 40193489496605(case), Lot Number: 21LBL067; 23) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22CBV220; 24) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 22KMC218; 25) DYNJ31344K, UDI-DI: 10195327089283(each), 40195327089284(case), Lot Number: 23CMG183; 26) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 22LME145; 27) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23BMG588; 28) DYNJ33393L, UDI-DI: 10195327302139(each), 40195327302130(case), Lot Number: 23EMG111; 29) DYNJ33393M, UDI-DI: 10195327567323(each), 40195327567324(case), Lot Number: 24AMC141; 30) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24HMH344; 31) DYNJ33393N, UDI-DI: 10195327616960(each), 40195327616961(case), Lot Number: 24LME743; 32) DYNJ33393O, UDI-DI: 10198459244537(each), 40198459244538(case), Lot Number: 25CMI389; 33) DYNJ36712F, UDI-DI: 10195327148027(each), 40195327148028(case), Lot Number: 22KBH638; 34) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 21LBI132; 35) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22ABL203; 36) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22BBZ962; 37) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22EBK097; 38) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 22GBK309; 39) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23BBC494; 40) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23DBD471; 41) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23FBJ953; 42) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23GBF010; 43) DYNJ45090I, UDI-DI: 10195327044794(each), 40195327044795(case), Lot Number: 23HBF942; 44) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21DBN261; 45) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21HBS940; 46) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 21KBQ945; 47) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22ABU361; 48) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22GBG579; 49) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 22HBB055; 50) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23DBQ854; 51) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23EBL258; 52) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23FBO439; 53) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23HBR561; 54) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23IBV025; 55) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 23JBH886; 56) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24FBC228; 57) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24GBV369; 58) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 24JBI039; 59) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25ABN265; 60) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25DBK709; 61) DYNJ45801C, UDI-DI: 10193489870381(each), 40193489870382(case), Lot Number: 25LBE575; 62) DYNJ47694I, UDI-DI: 10195327437046(each), 40195327437047(case), Lot Number: 24GMI287; 63) DYNJ51741B, UDI-DI: 10193489538939(each), 40193489538930(case), Lot Number: 22BBC761; 64) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23EMA454; 65) DYNJ58121C, UDI-DI: 10195327312398(each), 40195327312399(case), Lot Number: 23GMH701; 66) DYNJ59037B, UDI-DI: 10193489948196(each), 40193489948197(case), Lot Number: 22GBI562; 67) DYNJ59444G, UDI-DI: 10193489431650(each), 40193489431651(case), Lot Number: 20LMF707; 68) DYNJ61282B, UDI-DI: 10195327054663(each), 40195327054664(case), Lot Number: 24ABY154; 69) DYNJ67161, UDI-DI: 10193489396744(each), 40193489396745(case), Lot Number: 22CBY767; 70) DYNJ67708A, UDI-DI: 10195327039899(each), 40195327039890(case), Lot Number: 23JBW724; 71) DYNJ69713B, UDI-DI: 10195327340513(each), 40195327340514(case), Lot Number: 23JBY129; 72) DYNJ69713C, UDI-DI: 10195327594633(each), 40195327594634(case), Lot Number: 24EBR875; 73) DYNJ83560, UDI-DI: 10195327280291(each), 40195327280292(case), Lot Number: 23BBB410; 74) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMB138; 75) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22IMC843; 76) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 22JMF106; 77) DYNJ902560I, UDI-DI: 10193489949643(each), 40193489949644(case), Lot Number: 23AMI329; 78) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV715; 79) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21GBV717; 80) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBC695; 81) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 21KBH136; 82) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22ABL216; 83) DYNJ903327K, UDI-DI: 10193489432442(each), 40193489432443(case), Lot Number: 22HBB969; 84) DYNJ903475I, UDI-DI: 10195327565466(each), 40195327565467(case), Lot Number: 24HDB683; 85) DYNJ903798G, UDI-DI: 10193489420036(each), 40193489420037(case), Lot Number: 23ABR411; 86) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK509; 87) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23ABK510; 88) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23BBM781; 89) DYNJ908149, UDI-DI: 10193489982756(each), 40193489982757(case), Lot Number: 23EBV901; 90) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22BBV448; 91) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 22HBS469; 92) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23ABR402; 93) DYNJ908340, UDI-DI: 10195327046248(each), 40195327046249(case), Lot Number: 23CBD846; 94) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23EBR451; 95) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBE358; 96) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23HBT696; 97) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23IBF567; 98) DYNJ908340A, UDI-DI: 10195327360924(each), 40195327360925(case), Lot Number: 23JBI674; 99) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 23LBF494; 100) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBG247; 101) DYNJ908340B, UDI-DI: 10195327524845(each), 40195327524846(case), Lot Number: 24BBV876; 102) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBG486; 103) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24IBM046; 104) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 24JBK180; 105) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 25ABM341; 106) DYNJ908340D, UDI-DI: 10198459085901(each), 40198459085902(case), Lot Number: 25BBD946; 107) DYNJ908986, UDI-DI: 10195327236137(each), 40195327236138(case), Lot Number: 23CBU526; 108) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 23GBG857; 109) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 23IBD961; 110) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 23LBK573; 111) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 24BBD128; 112) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 24DBP068; 113) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 24EBD074; 114) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 24FBA074; 115) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 24GBS842; 116) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 24HBC611; 117) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 24IBV334; 118) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 24LBA906; 119) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 24LBE888; 120) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 25ABA371; 121) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 25BBB272; 122) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 25DBM017; 123) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 25FBE271; 124) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 25GBD479; 125) DYNJ908986A, UDI-DI: 10195327404499(each), 40195327404490(case), Lot Number: 25HBL521; 126) DYNJ910537, UDI-DI: 10198459029936(each), 40198459029937(case), Lot Number: 24GBX676; 127) DYNJ910927, UDI-DI: 10198459204326(each), 40198459204327(case), Lot Number: 25BMA247; 128) DYNJ910927, UDI-DI: 10198459204326(each), 40198459204327(case), Lot Number: 25CMJ281; 129) DYNJ910927, UDI-DI: 10198459204326(each), 40198459204327(case), Lot Number: 25FMA061; 130) DYNJ910927, UDI-DI: 10198459204326(each), 40198459204327(case), Lot Number: 25FMC511; 131) DYNJ910927, UDI-DI: 10198459204326(each), 40198459204327(case), Lot Number: 25GMJ120; 132) DYNJ910927, UDI-DI: 10198459204326(each), 40198459204327(case), Lot Number: 25LMG099; 133) DYNJ910927, UDI-DI: 10198459204326(each), 40198459204327(case), Lot Number: 25KMI687; 134) DYNJ910927, UDI-DI: 10198459204326(each), 40198459204327(case), Lot Number: 25JMC599; 135) DYNJT3348, UDI-DI: 10198459323751(each), 40198459323752(case), Lot Number: 25EBN202; 136) DYNJV0312G, UDI-DI: 10198459489051(each), 40198459489052(case), Lot Number: 25LME070

Product quantity

6676 units

Voluntary mandated

Voluntary: Firm initiated

City

Northfield

State

IL

Country

United States

Event id

98642

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