medical Class II Updated 2026-02-25

Medline Industries, LP recalls Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS,

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 2) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21CBD150; 3) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBM332; 4) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBL932; 5) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25GBB847; 6) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21IBS290; 7) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21GBE967; 8) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21FBB105; 9) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21DBC065; 10) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21CBQ508; 11) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22HBE127; 12) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22GBL821; 13) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBM235; 14) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBC878; 15) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP063; 16) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP060; 17) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21KBQ697; 18) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21HBB549; 19) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21FBB101; 20) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21DBE919; 21) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25GBG086; 22) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25EBM426; 23) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25BBI842; 24) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25ABF361; 25) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBH410; 26) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBE008; 27) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24KBD429; 28) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBH005; 29) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23CBK988; 30) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 20XBF598; 31) DYNJ04382J, UDI-DI: 10195327271763(each), 40195327271764(case), Lot Number: 22JMI206; 32) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23LBR468; 33) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23JBL141; 34) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21DBJ206; 35) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABL629; 36) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABK140; 37) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24FBJ094; 38) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23GMF146; 39) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23EME955; 40) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG245; 41) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG044; 42) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22GME486; 43) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22DMD888; 44) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22AME935; 45) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21LMB348; 46) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21IMB245; 47) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21GMF389; 48) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21FMA773; 49) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21DME541; 50) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21BMB150; 51) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21AMA560; 52) DYNJ41272C, UDI-DI: 10195327487409(each), 40195327487400(case), Lot Number: 23IMA347; 53) DYNJ42884, UDI-DI: 10888277011076(each), 40888277011077(case), Lot Number: 23CBJ945; 54) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24GBW285; 55) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24FBB582; 56) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24DBG903; 57) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23IBQ206; 58) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23GBP395; 59) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBV760; 60) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBQ343; 61) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23EBB329; 62) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23DBC104; 63) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23CBB298; 64) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23ABU921; 65) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22KBF536; 66) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22JBM589; 67) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22DBQ586; 68) DYNJ58344, UDI-DI: 10889942841721(each), 40889942841722(case), Lot Number: 21DBG514; 69) DYNJ67214D, UDI-DI: 10195327133320(each), 40195327133321(case), Lot Number: 22JBM637; 70) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23CBS078; 71) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23BBM551; 72) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 22LBT250; 73) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23LBG081; 74) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23GBI555; 75) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24DBB420; 76) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24ABG486; 77) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25LBI656; 78) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25KBT912; 79) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBL938; 80) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBC889; 81) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25GBO543; 82) DYNJ83475, UDI-DI: 10195327268411(each), 40195327268412(case), Lot Number: 23GBA918; 83) DYNJ87468, UDI-DI: 10198459041266(each), 40198459041267(case), Lot Number: 24HBC480; 84) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23FMD008; 85) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DME071; 86) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DMC062; 87) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23AMJ541; 88) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22JMF456; 89) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMC505; 90) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMA128; 91) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22GBP729; 92) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBG597; 93) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBD247; 94) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22BBE872; 95) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21JBW028; 96) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBI550; 97) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBA045; 98) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21HBK281; 99) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21FBL088; 100) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21DBC055; 101) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21ABU698; 102) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24EMG501; 103) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24CME409; 104) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24AMA976; 105) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23KMA629; 106) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23JMD404; 107) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25LMA690; 108) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25IMG392; 109) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25BMF779; 110) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 24IMI010; 111) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24LBF949; 112) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24KBT705; 113) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24JBH803; 114) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24HBU990; 115) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24GBW026; 116) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24EBJ699; 117) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24DBI465; 118) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24CBT820; 119) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBG800; 120) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBC557; 121) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24ABG736; 122) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23LBP758; 123) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBN910; 124) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBH145; 125) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23IBA468; 126) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23HBI647; 127) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25LMF580; 128) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25JBO532; 129) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25IBD839; 130) DYNJ906947C, UDI-DI: 10195327569006(each), 40195327569007(case), Lot Number: 24BBL769; 131) DYNJT6424, UDI-DI: 10198459553622(each), 40198459553623(case), Lot Number: 25KMI469
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