is it on recall

Recall archive / FDA device enforcement

See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPA... — FDA record Z-2098-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 7, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
See RES for complete list. Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: CDS860015V; 3) MAJOR LAPAROTOMY CDS, Model Number: CDS860015W; 4) MAJOR LAPAROTOMY CDS, Model Number: CDS860015X; 5) MINOR LAPAROTOMY CDS, Model Number: CDS860016P; 6) MINOR LAPAROTOMY CDS, Model Number: CDS860016Q; 7) MINOR LAPAROTOMY CDS, Model Number: CDS860016R; 8) MINOR LAPAROTOMY CDS, Model Number: CDS860016S; 9) LAP GASTRIC BYPASS CDS, Model Number: CDS860146M;
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.
Classification
Class II
Recalling firm
Medline Industries, LP
Quantity
114778 units
Agency-reported status
Ongoing
Source record identifier
Z-2098-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability1) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21FBR386; 2) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21GBS688; 3) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21IBL031; 4) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21KBB595; 5) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBD726; 6) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBT172; 7) CDS860015V, UDI-DI: 10195327209582(each), 40195327209583(case), Lot Number: 22HBF170; 8) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23FBP597; 9) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23GBM065; 10) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23HBT489; 11) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23JBR469; 12) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23KBX194; 13) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23LBQ388; 14) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBC504; 15) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBP400; 16) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24EBA340; 17) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25DBF532; 18) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25EBQ940; 19) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21EBD212; 20) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21FBC634; 21) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV761; 22) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV762; 23) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21KBI389; 24) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22ABD367; 25) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22BBL530; 26) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBH684; 27) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBQ637; 28) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22JBE511; 29) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22KBA835; 30) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 23ABM653; 31) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23GBD634; 32) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23IBO655; 33) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23KBP519; 34) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 24BBK121; 35) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24CBD741; 36) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24DBJ711; 37) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24GBQ718; 38) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24HBG876; 39) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24KBA566; 40) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24LBS320; 41) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25DBK311; 42) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25FBG578; 43) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25JBA926; 44) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25LMH226; 45) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23ABM631; 46) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23EBP265; 47) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23GBA234; 48) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23HBI319; 49) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23HBI540; 50) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23IBF963; 51) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23JBF435; 52) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23JBU728; 53) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23LBU990; 54) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24CBJ982; 55) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24DBD791; 56) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24EBF606; 57) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24FBG796; 58) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24FBS702; 59) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24GBW044; 60) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24JBL109; 61) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 24LBO824; 62) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 25BBL402; 63) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 25CBE080; 64) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 25DBS505; 65) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 25EBL045; 66) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 25GBB916; 67) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 25HBI741; 68) CDS982485N, UDI-DI: 10195327694173(each), 40195327694174(case), Lot Number: 24DDC016; 69) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21FBI691; 70) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21HBH225; 71) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21KBE056; 72) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22BBZ407; 73) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22EBC713; 74) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBA456; 75) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBS430; 76) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 22LBC678; 77) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 23ABD137; 78) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23BBM210; 79) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23EBE898; 80) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23GBG980; 81) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23IBN820; 82) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23IBP894; 83) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23JBI537; 84) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23KBK137; 85) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 24ABY635; 86) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 24BBO559; 87) CDS983311J, UDI-DI: 10193489424638(each), 40193489424639(case), Lot Number: 24CDA326; 88) CDS983411G, UDI-DI: 10193489353013(each), 40193489353014(case), Lot Number: 21ADB442; 89) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21DBT990; 90) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21FBL036; 91) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21HBF176; 92) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21JBA016; 93) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21VBA278; 94) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22ABC162; 95) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22DBR149; 96) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22FBB129; 97) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22FBE947; 98) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22GBJ161; 99) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22JBD756; 100) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22KBB066; 101) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22OBA586; 102) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22OBA973; 103) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 23ABB754; 104) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 23BBS348; 105) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 23CBT375; 106) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21CKA290; 107) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21EMB667; 108) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21FMD052; 109) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21HMD025; 110) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21IMH565; 111) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21KME682; 112) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21LMC119; 113) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 22AMA823; 114) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21AKB236; 115) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21CKA936; 116) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21EMA519; 117) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21FMF224; 118) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21HMC972; 119) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21JME070; 120) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21LMB717; 121) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21LMF036; 122) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22BMH264; 123) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22EMD492; 124) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22EMG101; 125) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22GME419; 126) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22HMA561; 127) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22IMF395; 128) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22IMI474; 129) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22JME156; 130) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22JME463; 131) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22LME600; 132) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23CME323; 133) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23DMB897; 13...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide - US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
May 13, 2026
Recall initiation date
Jan 7, 2026
Center classification date
May 7, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records

Medical devices recordsMedline Industries, LP records