Recall archive / FDA device enforcement
Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: C... — FDA record Z-1395-2026
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
- 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; 10) NEW LONDON MINOR CDS, Model Number: CDS982518M; 11) NEW LONDON MINOR CDS, Model Number: CDS982518N; 12) NEW LONDON MINOR CDS, Model Number: CDS982518O; 13) NEW LONDON MINOR CDS, Model Number: CDS982518P; 14) GENERAL LAPAROSCOPY CDS, Model Number: CDS983311J; 15) LAVH CDS, Model Number: CDS983411G; 16) NHP ROBOTIC GENERAL CDS, Model Number: CDS984244J; 17) ROBOTIC-LF, Model Number: CDS984543C; 18) CYSTO CDS, Model Number: CDS984592G; 19) CYSTO CDS, Model Number: CDS984592I; 20) ROBOTIC, Model Number: CDS985270F; 21) GENERAL LAPAROSCOPY CDS, Model Number: CDS985422I; 22) ROBOTIC CDS, Model Number: CDS985429L; 23) LAP CHOLE CDS, Model Number: CDS985558N; 24) LAP CHOLE CDS, Model Number: CDS985558O; 25) ENDO KIT, Model Number: DYKE1580A; 26) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105; 27) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105A; 28) KIT GEN SURG EXLAP, Model Number: DYKMBNDL105B; 29) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116; 30) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116B; 31) KIT UROLOGY URETHROPLASTY, Model Number: DYKMBNDL117A; 32) KIT SURG ONC DIAGNOSTIC LAPARO, Model Number: DYKMBNDL12; 33) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121; 34) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121A; 35) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121B; 36) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121C; 37) KIT UROLOGY LAP PHELAN, Model Number: DYKMBNDL121F; 38) KIT L&D CYSTO SETUP, Model Number: DYKMBNDL135A; 39) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136; 40) KIT THORACIC LAPAROSCOPIC HIAT, Model Number: DYKMBNDL136A; 41) KIT THORACIC STAGING LAPAROTOM, Model Number: DYKMBNDL15; 42) KIT SURG ONC LAP DIAG/CV CATH, Model Number: DYKMBNDL153A; 43) KIT SURG ONC LAP DIAG/PORT INS, Model Number: DYKMBNDL153B; 44) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173; 45) KIT LAP DONOR NEPHRECTOMY, Model Number: DYKMBNDL173A; 46) KIT THORACIC HIATAL HERNIA TRA, Model Number: DYKMBNDL175; 47) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176; 48) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176A; 49) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176B; 50) KIT GEN SURG LAP INGUINAL, Model Number: DYKMBNDL176C; 51) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184; 52) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184A; 53) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188A; 54) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193; 55) KIT UROLOGY LAP SIDDIQUI, Model Number: DYKMBNDL193...
- 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
- 82597 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1395-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBT172; 2) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21LBD726; 3) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21KBB595; 4) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21IBL031; 5) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21GBS688; 6) CDS860015U, UDI-DI: 10193489847994(each), 40193489847995(case), Lot Number: 21FBR386; 7) CDS860015V, UDI-DI: 10195327209582(each), 40195327209583(case), Lot Number: 22HBF170; 8) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23LBQ388; 9) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23KBX194; 10) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23JBR469; 11) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23HBT489; 12) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23GBM065; 13) CDS860015W, UDI-DI: 10195327349509(each), 40195327349500(case), Lot Number: 23FBP597; 14) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25EBQ940; 15) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 25DBF532; 16) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24EBA340; 17) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBP400; 18) CDS860015X, UDI-DI: 10195327647513(each), 40195327647514(case), Lot Number: 24DBC504; 19) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBQ637; 20) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22FBH684; 21) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22BBL530; 22) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 22ABD367; 23) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21KBI389; 24) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV762; 25) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21GBV761; 26) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21FBC634; 27) CDS860016P, UDI-DI: 10193489848007(each), 40193489848008(case), Lot Number: 21EBD212; 28) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 23ABM653; 29) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22KBA835; 30) CDS860016Q, UDI-DI: 10195327209599(each), 40195327209590(case), Lot Number: 22JBE511; 31) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 24BBK121; 32) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23KBP519; 33) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23IBO655; 34) CDS860016R, UDI-DI: 10195327349479(each), 40195327349470(case), Lot Number: 23GBD634; 35) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25LMH226; 36) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25JBA926; 37) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25FBG578; 38) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 25DBK311; 39) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24LBS320; 40) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24KBA566; 41) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24HBG876; 42) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24GBQ718; 43) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24DBJ711; 44) CDS860016S, UDI-DI: 10195327647520(each), 40195327647521(case), Lot Number: 24CBD741; 45) CDS860146M, UDI-DI: 10195327224547(each), 40195327224548(case), Lot Number: 23ABM631; 46) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22EBC713; 47) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 22BBZ407; 48) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21KBE056; 49) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21HBH225; 50) CDS982518M, UDI-DI: 10193489401028(each), 40193489401029(case), Lot Number: 21FBI691; 51) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBS430; 52) CDS982518N, UDI-DI: 10195327144166(each), 40195327144167(case), Lot Number: 22HBA456; 53) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 23ABD137; 54) CDS982518O, UDI-DI: 10195327247386(each), 40195327247387(case), Lot Number: 22LBC678; 55) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 24BBO559; 56) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 24ABY635; 57) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23KBK137; 58) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23JBI537; 59) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23IBP894; 60) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23IBN820; 61) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23GBG980; 62) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23EBE898; 63) CDS982518P, UDI-DI: 10195327318857(each), 40195327318858(case), Lot Number: 23BBM210; 64) CDS983311J, UDI-DI: 10193489424638(each), 40193489424639(case), Lot Number: 24CDA326; 65) CDS983411G, UDI-DI: 10193489353013(each), 40193489353014(case), Lot Number: 21ADB442; 66) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 23CBT375; 67) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 23BBS348; 68) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 23ABB754; 69) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22OBA973; 70) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22OBA586; 71) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22KBB066; 72) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22JBD756; 73) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22GBJ161; 74) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22FBE947; 75) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22FBB129; 76) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22DBR149; 77) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 22ABC162; 78) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21VBA278; 79) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21JBA016; 80) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21HBF176; 81) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21FBL036; 82) CDS984244J, UDI-DI: 10193489872514(each), 40193489872515(case), Lot Number: 21DBT990; 83) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 22AMA823; 84) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21LMC119; 85) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21KME682; 86) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21IMH565; 87) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21HMD025; 88) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21FMD052; 89) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21EMB667; 90) CDS984543C, UDI-DI: 10193489371017(each), 40193489371018(case), Lot Number: 21CKA290; 91) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 24AMA344; 92) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23LME580; 93) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23KMD724; 94) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23JMH749; 95) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23IMA630; 96) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23HME451; 97) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23GMB958; 98) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23FMI003; 99) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23DMG403; 100) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23DMC548; 101) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23DMC144; 102) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23DMB897; 103) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 23CME323; 104) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22LME600; 105) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22JME463; 106) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22JME156; 107) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22IMI474; 108) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22IMF395; 109) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22HMA561; 110) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22GME419; 111) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22EMG101; 112) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22EMD492; 113) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 22BMH264; 114) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21LMF036; 115) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21LMB717; 116) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21JME070; 117) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21HMC972; 118) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21FMF224; 119) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21EMA519; 120) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21CKA936; 121) CDS984592G, UDI-DI: 10193489485929(each), 40193489485920(case), Lot Number: 21AKB236; 122) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24HMJ929; 123) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24HMG227; 124) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24GMD392; 125) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24FMA343; 126) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24EMB806; 127) CDS984592I, UDI-DI: 10195327568573(each), 40195327568574(case), Lot Number: 24DMF734; 128) CDS985270F, UDI-DI: 10889942864683(each), 40889942864684(case), Lot Number: 21ADB484; 129) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22NBE570; 130) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22GBP860; 131) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22EBJ735; 132) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22DBJ084; 133) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 22ABF968; 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 distribution - US Nationwide.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 25, 2026
- Recall initiation date
- Jan 7, 2026
- Center classification date
- Feb 17, 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.