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Recall Observatory FDA recall evidence

Device product

Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431L; 6) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431N; 7) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 8) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 9) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 10) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 11) ROBOTIC PACK, Model Number: DYNJ04135B; 12) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 13) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 14) D&C PACK-LF, Model Number: DYNJ22567G; 15) D&C PACK-LF, Model Number: DYNJ22567I; 16) D&C PACK-LF, Model Number: DYNJ22567J; 17) D&C PACK-LF, Model Number: DYNJ22567K; 18) D&C HYSTEROSCOPY PACK, Model Number: DYNJ38805B; 19) D AND C, Model Number: DYNJ41272B; 20) D AND C, Model Number: DYNJ41272C; 21) OB PACK, Model Number: DYNJ42884; 22) D&C/GYN PACK, Model Number: DYNJ47713A; 23) PERI GYN PACK, Model Number: DYNJ55377D; 24) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 25) D&C PACK, Model Number: DYNJ67214D; 26) D&C PACK, Model Number: DYNJ67214F; 27) D&C PACK, Model Number: DYNJ67214G; 28) D&C PACK, Model Number: DYNJ67214I; 29) LITHOTOMY PACK, Model Number: DYNJ80765C; 30) GYN PACK, Model Number: DYNJ83475; 31) D AND C PACK, Model Number: DYNJ87468; 32) D&C-ASC, Model Number: DYNJ900465C; 33) D&C-ASC, Model Number: DYNJ900465D; 34) D&C-ASC, Model Number: DYNJ900465F; 35) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 36) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 37) D&C, Model Number: DYNJ906947C; 38) PACK PERI GYN DSMC, Model Number: DYNJT6424

Z-2112-2026

January 07, 2026

Class II

Product summary

Firm
Medline Industries, LP
Event
Event 98642
Status
Ongoing
Classification
Class II
Quantity
13376 units
Official record key
device-enforcement:Z-2112-2026

Official wording

Reason: 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.

Code information: 1) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21CBD150; 2) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 3) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23BBG608; 4) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23DBM469; 5) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23FBA948; 6) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBL932; 7) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBM332; 8) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23IBQ647; 9) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23JBF512; 10) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABA205; 11) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABV349; 12) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABW239; 13) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24CBR704; 14) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24EBP485; 15) CDS985431N, UDI-DI: 10198459081590(each), 40198459081591(case), Lot Number: 24JBG321; 16) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 24LBH099; 17) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25ABT899; 18) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25CBE670; 19) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25EBE265; 20) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25GBB847; 21) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25HBO500; 22) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21CBQ508; 23) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21DBC065; 24) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21FBB105; 25) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21GBE967; 26) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21IBS290; 27) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21DBE919; 28) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21FBB101; 29) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21HBB549; 30) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21KBQ697; 31) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP060; 32) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP063; 33) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBC878; 34) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBM235; 35) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22GBL821; 36) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22HBE127; 37) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24KBD429; 38) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBE008; 39) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBH410; 40) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25ABF361; 41) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25BBI842; 42) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25EBM426; 43) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25GBG086; 44) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 20XBF598; 45) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23CBK988; 46) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23EBS948; 47) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23HBP307; 48) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23JBY840; 49) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBH005; 50) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBM003; 51) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBT507; 52) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23LBM979; 53) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 24GBG491; 54) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 24KBD673; 55) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 25BBP569; 56) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 25CBA784; 57) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 25CBC135; 58) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 25FBM333; 59) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 25GBM691; 60) DYNJ04382J, UDI-DI: 10195327271763(each), 40195327271764(case), Lot Number: 22JMI206; 61) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23JBL141; 62) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23LBR468; 63) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 24ABL128; 64) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 24EBN152; 65) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 24HBT560; 66) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 24JBC325; 67) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 24JBM085; 68) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 24KBJ693; 69) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 25BBS711; 70) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABK140; 71) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABL629; 72) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21DBJ206; 73) DYNJ22567I, UDI-DI: 10195327174163(each), 40195327174164(case), Lot Number: 23BBL099; 74) DYNJ22567I, UDI-DI: 10195327174163(each), 40195327174164(case), Lot Number: 23EBV883; 75) DYNJ22567I, UDI-DI: 10195327174163(each), 40195327174164(case), Lot Number: 23HBL632; 76) DYNJ22567I, UDI-DI: 10195327174163(each), 40195327174164(case), Lot Number: 23HBO990; 77) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 23KBQ520; 78) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24ABR240; 79) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24BBS060; 80) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24EBG664; 81) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24FBJ094; 82) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24HBJ392; 83) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24KBH224; 84) DYNJ22567K, UDI-DI: 10198459237478(each), 40198459237479(case), Lot Number: 25BBD832; 85) DYNJ22567K, UDI-DI: 10198459237478(each), 40198459237479(case), Lot Number: 25BBR838; 86) DYNJ22567K, UDI-DI: 10198459237478(each), 40198459237479(case), Lot Number: 25DBF981; 87) DYNJ22567K, UDI-DI: 10198459237478(each), 40198459237479(case), Lot Number: 25EBM314; 88) DYNJ22567K, UDI-DI: 10198459237478(each), 40198459237479(case), Lot Number: 25FBR085; 89) DYNJ38805B, UDI-DI: 10888277540835(each), 40888277540836(case), Lot Number: 20XBD674; 90) DYNJ38805B, UDI-DI: 10888277540835(each), 40888277540836(case), Lot Number: 21JBA684; 91) DYNJ38805B, UDI-DI: 10888277540835(each), 40888277540836(case), Lot Number: 21JBB065; 92) DYNJ38805B, UDI-DI: 10888277540835(each), 40888277540836(case), Lot Number: 21KBE308; 93) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21AMA560; 94) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21BMB150; 95) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21DME541; 96) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21FMA773; 97) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21GMF389; 98) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21IMB245; 99) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21LMB348; 100) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22AME935; 101) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22DMD888; 102) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22GME486; 103) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG044; 104) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG245; 105) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23EME955; 106) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23GMF146; 107) DYNJ41272C, UDI-DI: 10195327487409(each), 40195327487400(case), Lot Number: 23IMA347; 108) DYNJ42884, UDI-DI: 10888277011076(each), 40888277011077(case), Lot Number: 23CBJ945; 109) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23BBD635; 110) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23CBN687; 111) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23EBB118; 112) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23FBO918; 113) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23GBP395; 114) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23IBQ206; 115) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23JBX471; 116) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23LBS267; 117) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24CBB964; 118) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24DBG903; 119) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24FBB582; 120) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24GBW285; 121) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24HBV934; 122) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24JBL817; 123) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24LBH516; 124) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 25CBJ104; 125) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 25DBV193; 126) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 25GBE054; 127) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 25HBR409; 128) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22DBQ586; 129) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22JBM589; 130) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22KBF536; 131) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23ABU921; 132) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23CBB298; 133) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23DBC104; 134) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23EBB329; 135) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBQ343; 136) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBV760; 137) DYNJ58344, UDI-DI: 10889942841721(each), 40889942841722(case), Lot Number: 21DBG514; 138) DYNJ67214D, UDI-DI: 10195327133320(each), 40195327133321(case), Lot Number: 22JBM637; 139) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 22LBT250; 140) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23BBM551; 141) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23CBS078; 142) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23GBI555; 143) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23LBG081; 144) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24ABG486; 145) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24DBB420; 146) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25GBO543; 147) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBC889; 148) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBL938; 149) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25KBT912; 150) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25LBI656; 151) DYNJ83475, UDI-DI: 10195327268411(each), 40195327268412(case), Lot Number: 23GBA918; 152) DYNJ87468, UDI-DI: 10198459041266(each), 40198459041267(case), Lot Number: 24HBC480; 153) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21ABU698; 154) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21DBC055; 155) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21FBL088; 156) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21HBK281; 157) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBA045; 158) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBI550; 159) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21JBW028; 160) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22BBE872; 161) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBD247; 162) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBG597; 163) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22GBP729; 164) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMA128; 165) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMC505; 166) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22JMF456; 167) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23AMJ541; 168) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DMC062; 169) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DME071; 170) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23FMD008; 171) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23JMD404; 172) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23KMA629; 173) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24AMA976; 174) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24CME409; 175) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24EMG501; 176) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 24IMI010; 177) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25BMF779; 178) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25CMB478; 179) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25EMB409; 180) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25GMG695; 181) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25IMG392; 182) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25LMA690; 183) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23HBI647; 184) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23IBA468; 185) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBH145; 186) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBN910; 187) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23LBP758; 188) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24ABG736; 189) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBC557; 190) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBG800; 191) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24CBT820; 192) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24DBI465; 193) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24EBJ699; 194) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24GBW026; 195) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24HBU990; 196) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24JBH803; 197) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24KBT705; 198) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24LBF949; 199) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25IBD839; 200) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25JBO532; 201) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25LMF580; 202) DYNJ906947C, UDI-DI: 10195327569006(each), 40195327569007(case), Lot Number: 24BBL769; 203) DYNJT6424, UDI-DI: 10198459553622(each), 40198459553623(case), Lot Number: 25KMI469

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

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