Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL9

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT G by Medline Industries, LP. Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali.

Details

Product Description

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

Lot/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

Quantity Affected: 6676 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-01-07

Company