Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model...
FDA Recall #Z-1417-2026 — Class II — January 7, 2026
Product Description
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: DYNJ19529P; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 11) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 12) C-SECTION PACK, Model Number: DYNJ23544F; 13) C-SECTION PACK, Model Number: DYNJ32632F; 14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 15) C-SECTION PACK-LF, Model Number: DYNJ38801F; 16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 17) C-SECTION, Model Number: DYNJ41444F; 18) C-SECTION PACK, Model Number: DYNJ49224I; 19) C SECTION PACK-LF, Model Number: DYNJ52387I; 20) C-SECTION PACK, Model Number: DYNJ56523C; 21) C-SECTION PACK, Model Number: DYNJ59387L; 22) C-SECTION PACK, Model Number: DYNJ64549B; 23) C SECTION PACK, Model Number: DYNJ67347A; 24) C SECTION PACK, Model Number: DYNJ69778A; 25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 27) PAD C-SECTION, Model Number: DYNJ902134C; 28) RICH C-SECTION, Model Number: DYNJ902182J; 29) C-SECTION PACK, Model Number: DYNJ904329D; 30) C-SECTION, Model Number: DYNJ904697F; 31) KIT C SECTION, Model Number: DYNJ906966G; 32) C SECTION, Model Number: DYNJ907999A; 33) C-SECTION, Model Number: DYNJ909058; 34) C-SECTION PACK, Model Number: DYNJ909507; 35) C SECTION TRAY, Model Number: DYNJT3407; 36) TR-C SECTION PACK-LF, Model Number: PHS583549002B
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.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4525 units
Distribution
Worldwide distribution - US Nationwide.
Code Information
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: 21WBA953; 4) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21LBC555; 5) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21CBN328; 6) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22IBG757; 7) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU298; 8) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU297; 9) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU296; 10) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22EBA155; 11) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBT090; 12) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBH774; 13) DYNJ0101616I, UDI-DI: 10193489248814(each), 40193489248815(case), Lot Number: 21ADA105; 14) DYNJ15494G, UDI-DI: 10193489961195(each), 40193489961196(case), Lot Number: 22LBS122; 15) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24GMF054; 16) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24FMB372; 17) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMB123; 18) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMD085; 19) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23LME909; 20) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 25BMB041; 21) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24LMH886; 22) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24KMD458; 23) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25IMA090; 24) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25FMI427; 25) DYNJ19529S, UDI-DI: 10198459566257(each), 40198459566258(case), Lot Number: 25KMA045; 26) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBL994; 27) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBJ153; 28) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21BBM422; 29) DYNJ23544F, UDI-DI: 10889942533053(each), 40889942533054(case), Lot Number: 23IMA860; 30) DYNJ32632F, UDI-DI: 10193489888966(each), 40193489888967(case), Lot Number: 22HMC526; 31) DYNJ35100I, UDI-DI: 10195327097608(each), 40195327097609(case), Lot Number: 23IME105; 32) DYNJ38801F, UDI-DI: 10195327113117(each), 40195327113118(case), Lot Number: 23IBK585; 33) DYNJ40129C, UDI-DI: 10193489441772(each), 40193489441773(case), Lot Number: 23AMJ303; 34) DYNJ41444F, UDI-DI: 10193489740974(each), 40193489740975(case), Lot Number: 22JMB590; 35) DYNJ49224I, UDI-DI: 10193489371352(each), 40193489371353(case), Lot Number: 21DDA358; 36) DYNJ52387I, UDI-DI: 10193489248272(each), 40193489248273(case), Lot Number: 21ADA540; 37) DYNJ56523C, UDI-DI: 10193489430264(each), 40193489430265(case), Lot Number: 21ABS513; 38) DYNJ59387L, UDI-DI: 10195327159856(each), 40195327159857(case), Lot Number: 23CBK420; 39) DYNJ64549B, UDI-DI: 10193489940725(each), 40193489940726(case), Lot Number: 23ABL355; 40) DYNJ67347A, UDI-DI: 10195327046156(each), 40195327046157(case), Lot Number: 22JMF954; 41) DYNJ69778A, UDI-DI: 10195327334420(each), 40195327334421(case), Lot Number: 23CBU899; 42) DYNJ900602I, UDI-DI: 10193489487121(each), 40193489487122(case), Lot Number: 20LDB302; 43) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25JDA979; 44) DYNJ902134C, UDI-DI: 10193489452280(each), 40193489452281(case), Lot Number: 21DBP451; 45) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 23ABM580; 46) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22OBJ456; 47) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22JBO865; 48) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22IBI254; 49) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22HBF417; 50) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22GBH232; 51) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22EBG610; 52) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22DBN664; 53) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22ABY311; 54) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBX738; 55) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBJ172; 56) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21IBL808; 57) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21GBB842; 58) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBS046; 59) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBQ743; 60) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21BBF750; 61) DYNJ904329D, UDI-DI: 10198459221071(each), 40198459221072(case), Lot Number: 25EBJ650; 62) DYNJ904697F, UDI-DI: 10195327169275(each), 40195327169276(case), Lot Number: 22FDA703; 63) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBS185; 64) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBF270; 65) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBV882; 66) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBR695; 67) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24DBN053; 68) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24BBV274; 69) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 22CMH174; 70) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21LMB616; 71) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21JMC590; 72) DYNJ909058, UDI-DI: 10195327259327(each), 40195327259328(case), Lot Number: 23EBP308; 73) DYNJ909507, UDI-DI: 10195327387075(each), 40195327387076(case), Lot Number: 23GME519; 74) DYNJT3407, UDI-DI: 10198459324970(each), 40198459324971(case), Lot Number: 25EBK673; 75) PHS583549002B, UDI-DI: 10193489643558(each), 40193489643559(case), Lot Number: 21ADA554
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated