Medline Industries, LP: Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529O; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 11) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 12) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 13) C-SECTION PACK, Model Number: DYNJ23544F; 14) C-SECTION PACK, Model Number: DYNJ32632F; 15) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 16) C-SECTION PACK, Model Number: DYNJ35902F; 17) C-SECTION PACK-LF, Model Number: DYNJ38801F; 18) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 19) C-SECTION, Model Number: DYNJ41444F; 20) C-SECTION PACK, Model Number: DYNJ49224I; 21) C-SECTION PACK, Model Number: DYNJ49771A; 22) C-SECTION PACK, Model Number: DYNJ49771B; 23) C SECTION PACK-LF, Model Number: DYNJ52387I; 24) C-SECTION PACK, Model Number: DYNJ53528B; 25) C SECTION PACK-LF, Model Number: DYNJ55367A; 26) C-SECTION PACK, Model Number: DYNJ56523C; 27) C-SECTION PACK, Model Number: DYNJ59387L; 28) C-SECTION PACK, Model Number: DYNJ59387M; 29) C-SECTION PACK, Model Number: DYNJ59387N; 30) C-SECTION PACK, Model Number: DYNJ59387O; 31) C-SECTION PACK, Model Number: DYNJ59387P; 32) C-SECTION TRAY, Model Number: DYNJ62707B; 33) C-SECTION PACK, Model Number: DYNJ64549B; 34) C SECTION PACK, Model Number: DYNJ67347A; 35) C SECTION PACK, Model Number: DYNJ69778A; 36) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 37) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 38) PAD C-SECTION, Model Number: DYNJ902134C; 39) RICH C-SECTION, Model Number: DYNJ902182J; 40) C-SECTION, Model Number: DYNJ902938J; 41) C-SECTION PACK, Model Number: DYNJ904329D; 42) OB DELIVERY KIT, Model Number: DYNJ904453C; 43) C-SECTION, Model Number: DYNJ904697F; 44) C-SECTION, Model Number: DYNJ906255B; 45) KIT C SECTION, Model Number: DYNJ906966G; 46) C SECTION, Model Number: DYNJ907999A; 47) KIT C SECTION OR, Model Number: DYNJ908350C; 48) C-SECTION, Model Number: DYNJ909058; 49) C SECTION, Model Number: DYNJ909475A; 50) C-SECTION PACK, Model Number: DYNJ909507; 51) C-SECTION, Model Number: DYNJ910199; 52) C-SECTION, Model Number: DYNJ910199A; 53) C SECTION TRAY, Model Number: DYNJT3407; 54) C-SECTION BASIN PACK, Model Number: OBP211C; 55) TR-C SECTION PACK-LF, Model Number: PHS583549002B
- 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) CDS820080N, UDI-DI: 10195327278014(each), 40195327278015(case), Lot Number: 23IMB818; 2) CDS983523G, UDI-DI: 10195327283681(each), 40195327283682(case), Lot Number: 23IBS984; 3) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21CBN328; 4) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21LBC555; 5) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21WBA953; 6) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBH774; 7) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBT090; 8) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22EBA155; 9) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU296; 10) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU297; 11) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU298; 12) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22IBG757; 13) DYNJ0101616I, UDI-DI: 10193489248814(each), 40193489248815(case), Lot Number: 21ADA105; 14) DYNJ15494G, UDI-DI: 10193489961195(each), 40193489961196(case), Lot Number: 22LBS122; 15) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23CMB465; 16) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23DMH505; 17) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23FMF781; 18) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23IMB944; 19) DYNJ19529O, UDI-DI: 10195327297206(each), 40195327297207(case), Lot Number: 23IME367; 20) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23JMD920; 21) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23JMI854; 22) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23LME909; 23) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMD085; 24) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMI385; 25) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24BMG152; 26) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24CMJ610; 27) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMB123; 28) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMD740; 29) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24FMB372; 30) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24GMF054; 31) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24KMD458; 32) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24LMH886; 33) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 25BMB041; 34) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25DMA214; 35) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25EMH398; 36) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25FMI427; 37) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25GMH469; 38) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25IMA090; 39) DYNJ19529S, UDI-DI: 10198459566257(each), 40198459566258(case), Lot Number: 25KMA045; 40) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21BBM422; 41) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBJ153; 42) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBL994; 43) DYNJ23544F, UDI-DI: 10889942533053(each), 40889942533054(case), Lot Number: 23IMA860; 44) DYNJ32632F, UDI-DI: 10193489888966(each), 40193489888967(case), Lot Number: 22HMC526; 45) DYNJ35100I, UDI-DI: 10195327097608(each), 40195327097609(case), Lot Number: 23IME105; 46) DYNJ35902F, UDI-DI: 10193489920109(each), 40193489920100(case), Lot Number: 23ABF399; 47) DYNJ38801F, UDI-DI: 10195327113117(each), 40195327113118(case), Lot Number: 23IBK585; 48) DYNJ40129C, UDI-DI: 10193489441772(each), 40193489441773(case), Lot Number: 23AMJ303; 49) DYNJ41444F, UDI-DI: 10193489740974(each), 40193489740975(case), Lot Number: 22JMB590; 50) DYNJ49224I, UDI-DI: 10193489371352(each), 40193489371353(case), Lot Number: 21DDA358; 51) DYNJ49771A, UDI-DI: 10198459015717(each), 40198459015718(case), Lot Number: 24GBN350; 52) DYNJ49771B, UDI-DI: 10198459087776(each), 40198459087777(case), Lot Number: 24IBI305; 53) DYNJ52387I, UDI-DI: 10193489248272(each), 40193489248273(case), Lot Number: 21ADA540; 54) DYNJ53528B, UDI-DI: 10195327077303(each), 40195327077304(case), Lot Number: 23GBT514; 55) DYNJ55367A, UDI-DI: 10889942858903(each), 40889942858904(case), Lot Number: 24CBS240; 56) DYNJ56523C, UDI-DI: 10193489430264(each), 40193489430265(case), Lot Number: 21ABS513; 57) DYNJ59387L, UDI-DI: 10195327159856(each), 40195327159857(case), Lot Number: 23CBK420; 58) DYNJ59387M, UDI-DI: 10195327442064(each), 40195327442065(case), Lot Number: 23HBP931; 59) DYNJ59387N, UDI-DI: 10195327492557(each), 40195327492558(case), Lot Number: 23JBO439; 60) DYNJ59387O, UDI-DI: 10195327590079(each), 40195327590070(case), Lot Number: 24ABC320; 61) DYNJ59387O, UDI-DI: 10195327590079(each), 40195327590070(case), Lot Number: 24FMJ621; 62) DYNJ59387O, UDI-DI: 10195327590079(each), 40195327590070(case), Lot Number: 24GMD352; 63) DYNJ59387O, UDI-DI: 10195327590079(each), 40195327590070(case), Lot Number: 24GME349; 64) DYNJ59387O, UDI-DI: 10195327590079(each), 40195327590070(case), Lot Number: 24GMJ147; 65) DYNJ59387O, UDI-DI: 10195327590079(each), 40195327590070(case), Lot Number: 24HMD358; 66) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 24HBU368; 67) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 24JBP235; 68) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 24KBE601; 69) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 24LMB875; 70) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 25AMH030; 71) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 25BMB382; 72) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 25CMG270; 73) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 25FMB960; 74) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 25FMG755; 75) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 25GMK050; 76) DYNJ59387P, UDI-DI: 10198459097447(each), 40198459097448(case), Lot Number: 25HMI033; 77) DYNJ62707B, UDI-DI: 10195327292140(each), 40195327292141(case), Lot Number: 25ABV465; 78) DYNJ64549B, UDI-DI: 10193489940725(each), 40193489940726(case), Lot Number: 23ABL355; 79) DYNJ67347A, UDI-DI: 10195327046156(each), 40195327046157(case), Lot Number: 22JMF954; 80) DYNJ69778A, UDI-DI: 10195327334420(each), 40195327334421(case), Lot Number: 23CBU899; 81) DYNJ900602I, UDI-DI: 10193489487121(each), 40193489487122(case), Lot Number: 20LDB302; 82) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 23ADB906; 83) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 23BDB272; 84) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 23DDA960; 85) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 23GDA465; 86) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 23HDB760; 87) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 23IDB372; 88) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 23JDC028; 89) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 23LDA543; 90) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 24DDA865; 91) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 24DDC210; 92) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 24EDA956; 93) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 24FDB598; 94) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 24HDB497; 95) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 24JDA466; 96) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 24JDB666; 97) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 24JDC302; 98) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 24LDA598; 99) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25ADA998; 100) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25BDB001; 101) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25DDA885; 102) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25FDA524; 103) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25FDB748; 104) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25GDB840; 105) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25JDA979; 106) DYNJ902134C, UDI-DI: 10193489452280(each), 40193489452281(case), Lot Number: 21DBP451; 107) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21BBF750; 108) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBQ743; 109) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBS046; 110) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21GBB842; 111) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21IBL808; 112) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBJ172; 113) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBX738; 114) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22ABY311; 115) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22DBN664; 116) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22EBG610; 117) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22GBH232; 118) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22HBF417; 119) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22IBI254; 120) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22JBO865; 121) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22OBJ456; 122) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 23ABM580; 123) DYNJ902938J, UDI-DI: 10193489946116(each), 40193489946117(case), Lot Number: 24CMH453; 124) DYNJ904329D, UDI-DI: 10198459221071(each), 40198459221072(case), Lot Number: 25EBJ650; 125) DYNJ904453C, UDI-DI: 10198459005725(each), 40198459005726(case), Lot Number: 25JBQ639; 126) DYNJ904697F, UDI-DI: 10195327169275(each), 40195327169276(case), Lot Number: 22FDA703; 127) DYNJ906255B, UDI-DI: 10198459196782(each), 40198459196783(case), Lot Number: 25BDA042; 128) DYNJ906255B, UDI-DI: 10198459196782(each), 40198459196783(case), Lot Number: 25DDB842; 129) DYNJ906255B, UDI-DI: 10198459196782(each), 40198459196783(case), Lot Number: 25EDB771; 130) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24BBV274; 131) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24DBN053; 132) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBR695; 133) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBV882; 134) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBF270; 135) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBS185; 136) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21JMC590; 137) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21LMB616; 138) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 22CMH174; 139) DYNJ908350C, UDI-DI: 10198459154478(each), 40198459154479(case), Lot Number: 24KBJ980; 140) DYNJ908350C, UDI-DI: 10198459154478(each), 40198459154479(case), Lot Number: 24LBT358; 141) DYNJ908350C, UDI-DI: 10198459154478(each), 40198459154479(case), Lot Number: 25ABI501; 142) DYNJ908350C, UDI-DI: 10198459154478(each), 40198459154479(case), Lot Number: 25CBL793; 143) DYNJ908350C, UDI-DI: 10198459154478(each), 40198459154479(case), Lot Number: 25DBP813; 144) DYNJ908350C, UDI-DI: 10198459154478(each), 40198459154479(case), Lot Number: 25FBW044; 145) DYNJ908350C, UDI-DI: 10198459154478(each), 40198459154479(case), Lot Number: 25HBO502; 146) DYNJ909058, UDI-DI: 10195327259327(each), 40195327259328(case), Lot Number: 23EBP308; 147) DYNJ909058, UDI-DI: 10195327259327(each), 40195327259328(case), Lot Number: 23HBF069; 148) DYNJ909058, UDI-DI: 10195327259327(each), 40195327259328(case), Lot Number: 23HBY877; 149) DYNJ909475A, UDI-DI: 10195327647155(each), 40195327647156(case), Lot Number: 25FMI114; 150) DYNJ909507, UDI-DI: 10195327387075(each), 40195327387076(case), Lot Number: 23GME519; 151) DYNJ910199, UDI-DI: 10195327612122(each), 40195327612123(case), Lot Number: 24DBM917; 152) DYNJ910199, UDI-DI: 10195327612122(each), 40195327612123(case), Lot Number: 24DBN447; 153) DYNJ910199A, UDI-DI: 10198459130656(each), 40198459130657(case), Lot Number: 24JBP901; 154) DYNJ910199A, UDI-DI: 10198459130656(each), 40198459130657(case), Lot Number: 24KBD622; 155) DYNJ910199A, UDI-DI: 10198459130656(each), 40198459130657(case), Lot Number: 25BBC088; 156) DYNJT3407, UDI-DI: 10198459324970(each), 40198459324971(case), Lot Number: 25EBK673; 157) OBP211C, UDI-DI: 10884389069745(each), 40884389069746(case), Lot Number: 25DBE903; 158) PHS583549002B, UDI-DI: 10193489643558(each), 40193489643559(case), Lot Number: 21ADA554
- Product quantity
- 12529 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98642
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