FDAClass IIMay 13, 2026

Medline Convenience Kits: 1) C-SECTION PACK recall: Sterility Concern

Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number…

Why was Medline Convenience Kits: 1) C-SECTION PACK recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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
Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number…
Recalling firm
Medline Industries, LP
Quantity
12529 units
Distribution
Worldwide - US Nationwide distribution.
Recall date
May 13, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls