RecallHawk
Class II Recall

Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR LAPAROTOMY CDS, Model Number: C

Medline Industries, LP

Summary

The FDA issued a Class II for Medline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; by Medline Industries, LP. Reason: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the vali.

Details

Source

Device Recall

External ID

Z-1395-2026

Action Date

2026-02-25

Status

Ongoing

Category

device

Product Description

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: DYKMBNDL193A; 56) KIT UROLOGY BUCCAL GRAFT, Model Number: DYKMBNDL206; 57) KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; 58) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60; 59) KIT UROLOGY CYSTOSCOPY SUPPLEM, Model Number: DYKMBNDL60A; 60) KIT UROLOGY MINOR, Model Number: DYKMBNDL61A; 61) KIT UROLOGY MINOR, Model Number: DYKMBNDL61B; 62) KIT GEN SURG LAP COLECTOMY, Model Number: DYKMBNDL73; 63) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73A; 64) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73B; 65) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73C; 66) KIT GEN SURG LAP COLORECTAL, Model Number: DYKMBNDL73D; 67) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74; 68) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74A; 69) KIT GEN SURG LAP GASTRIC BYPAS, Model Number: DYKMBNDL74B; 70) KIT GEN SURG LAP GASTRIC BYPAS,

Lot/Code Info: 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; 134) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21KBR555; 135) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21JBM744; 136) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21HBN935; 137) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21HBN934; 138) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21EBI573; 139) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21CBZ732; 140) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21CBQ720; 141) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21BBB192; 142) CDS985422I, UDI-DI: 10193489319316(each), 40193489319317(case), Lot Number: 21BBA014; 143) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 22OBC139; 144) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 22GBD838; 145) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 22EBV213; 146) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 22ABY343; 147) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 21LBU039; 148) CDS985429L, UDI-DI: 10193489319262(each), 40193489319263(case), Lot Number: 21JBF851; 149) CDS985558N, UDI-DI: 10193489487343(each), 40193489487344(case), Lot Number: 21HBJ869; 150) CDS985558N, UDI-DI: 10193489487343(each), 40193489487344(case), Lot Number: 21FBO771; 151) CDS985558N, UDI-DI: 10193489487343(each), 40193489487344(case), Lot Number: 21FBF387; 152) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 23DBH534; 153) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 23DBE098; 154) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 23CBH215; 155) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 23ABF065; 156) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22OBE746; 157) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22JBT595; 158) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22IBT627; 159) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22FBV606; 160) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22EBQ394; 161) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22EBK620; 162) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22EBA491; 163) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 22CBG806; 164) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 21LBT009; 165) CDS985558O, UDI-DI: 10193489969061(each), 40193489969062(case), Lot Number: 21JBL422; 166) DYKE1580A, UDI-DI: 10193489432237(each), 40193489432238(case), Lot Number: 21DBF753; 167) DYKE1580A, UDI-DI: 10193489432237(each), 40193489432238(case), Lot Number: 21ABX247; 168) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 24BBE022; 169) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 24ABO459; 170) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23KBS983; 171) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23JBY272; 172) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23HBT455; 173) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23HBO182; 174) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23CBP835; 175) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 23CBA392; 176) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22LBL912; 177) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22KBF614; 178) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22JBI876; 179) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22IBS852; 180) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22IBG856; 181) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22HBQ095; 182) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22GBT273; 183) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22FBV210; 184) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 22FBR125; 185) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21JBU233; 186) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21GBR346; 187) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21FBP719; 188) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21DBF835; 189) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21BBH635; 190) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21BBA025; 191) DYKMBNDL105, UDI-DI: 10193489478952(each), 40193489478953(case), Lot Number: 21ABI966; 192) DYKMBNDL105A, UDI-DI: 10195327633776(each), 40195327633777(case), Lot Number: 24CBR484; 193) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 25ABO965; 194) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 25ABD849; 195) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24LBS832; 196) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24LBF747; 197) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24JBI870; 198) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24HBD158; 199) DYKMBNDL105B, UDI-DI: 10198459000683(each), 40198459000684(case), Lot Number: 24DBR906; 200) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21CBI082; 201) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21CBF516; 202) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ALA406; 203) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ALA324; 204) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ABU308; 205) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ABS541; 206) DYKMBNDL116, UDI-DI: 10193489479331(each), 40193489479332(case), Lot Number: 21ABP683; 207) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 23CBP082; 208) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 23BBQ048; 209) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 23ABM976; 210) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 22LBH335; 211) DYKMBNDL116B, UDI-DI: 10195327240660(each), 40195327240661(case), Lot Number: 22JBM224; 212) DYKMBNDL117A, UDI-DI: 10193489882773(each), 40193489882774(case), Lot Number: 22ELA421; 213) DYKMBNDL117A, UDI-DI: 10193489882773(each), 40193489882774(case), Lot Number: 22ALA614; 214) DYKMBNDL117A, UDI-DI: 10193489882773(each), 40193489882774(case), Lot Number: 21ILA049; 215) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25HBV157; 216) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25GBH906; 217) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25EBT272; 218) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25EBM208; 219) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25DBK742; 220) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25BBA443; 221) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 25ABG274; 222) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24KBT014; 223) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24JBD656; 224) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24HBG307; 225) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24GBV668; 226) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24EBV298; 227) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 24ABX945; 228) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23JBB703; 229) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23IBJ531; 230) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23HBH772; 231) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23GBM663; 232) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23FBQ220; 233) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 23BBS803; 234) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22LBM792; 235) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22LBK906; 236) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22IBR709; 237) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22HBT845; 238) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22GBG153; 239) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22EBQ052; 240) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22EBB288; 241) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22DBQ840; 242) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22DBP449; 243) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22DBP086; 244) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22DBP077; 245) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 22ABO074; 246) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21LBV341; 247) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21LBT163; 248) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21LBP648; 249) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21LBO672; 250) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21JBQ908; 251) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21IBP754; 252) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21HBN005; 253) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21GBJ359; 254) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21DBJ863; 255) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21DBC546; 256) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21CBE514; 257) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21ABR762; 258) DYKMBNDL12, UDI-DI: 10193489478617(each), 40193489478618(case), Lot Number: 21ABM150; 259) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21CBV963; 260) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21CBS661; 261) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21CBE524; 262) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21BBG050; 263) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21ABM463; 264) DYKMBNDL121, UDI-DI: 10193489478099(each), 40193489478090(case), Lot Number: 21ABI969; 265) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22HLA998; 266) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22FLA994; 267) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22ELA175; 268) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22ELA051; 269) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22ELA007; 270) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22DLA673; 271) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22DLA406; 272) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22DLA132; 273) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22CLA524; 274) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22CLA149; 275) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22BLA626; 276) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 22ALA028; 277) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21LLA312; 278) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21KLA523; 279) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21JLA652; 280) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21JLA001; 281) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21ILA935; 282) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21HLB016; 283) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21HLA548; 284) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21GLA171; 285) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21FLA210; 286) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21ELA833; 287) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21ELA413; 288) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21ELA387; 289) DYKMBNDL121A, UDI-DI: 10193489880694(each), 40193489880695(case), Lot Number: 21DLA540; 290) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 23CLA551; 291) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 23BLA368; 292) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 22LLA491; 293) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 22KLA012; 294) DYKMBNDL121B, UDI-DI: 10195327240684(each), 40195327240685(case), Lot Number: 22ILA068; 295) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 24ALA168; 296) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23KLA555; 297) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23JLA993; 298) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23ILA468; 299) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23GLB004; 300) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23FLB006; 301) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23ELA668; 302) DYKMBNDL121C, UDI-DI: 10195327371067(each), 40195327371068(case), Lot Number: 23CLA837; 303) DYKMBNDL121F, UDI-DI: 10198459000713(each), 40198459000714(case), Lot Number: 24FLA948; 304) DYKMBNDL121F, UDI-DI: 10198459000713(each), 40198459000714(case), Lot Number: 24FLA318; 305) DYKMBNDL135A, UDI-DI: 10195327244224(each), 40195327244225(case), Lot Number: 23KBI973; 306) DYKMBNDL135A, UDI-DI: 10195327244224(each), 40195327244225(case), Lot Number: 23KBE452; 307) DYKMBNDL135A, UDI-DI: 10195327244224(each), 40195327244225(case), Lot Number: 22LBO995; 308) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 24ABX941; 309) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 24ABG851; 310) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 23KBF074; 311) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 21BBG515; 312) DYKMBNDL136, UDI-DI: 10193489478136(each), 40193489478137(case), Lot Number: 21ABI971; 313) DYKMBNDL136A, UDI-DI: 10198459000720(each), 40198459000721(case), Lot Number: 24DBR914; 314) DYKMBNDL15, UDI-DI: 10193489477580(each), 40193489477581(case), Lot Number: 21BBG088; 315) DYKMBNDL15, UDI-DI: 10193489477580(each), 40193489477581(case), Lot Number: 21ABI974; 316) DYKMBNDL153A, UDI-DI: 10195327240516(each), 40195327240517(case), Lot Number: 22KBJ482; 317) DYKMBNDL153B, UDI-DI: 10195327369057(each), 40195327369058(case), Lot Number: 23FBB469; 318) DYKMBNDL173, UDI-DI: 10193489478327(each), 40193489478328(case), Lot Number: 21BBA252; 319) DYKMBNDL173, UDI-DI: 10193489478327(each), 40193489478328(case), Lot Number: 21ALA522; 320) DYKMBNDL173, UDI-DI: 10193489478327(each), 40193489478328(case), Lot Number: 20LBY935; 321) DYKMBNDL173, UDI-DI: 10193489478327(each), 40193489478328(case), Lot Number: 20LBK822; 322) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 22CLA526; 323) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 22ALA404; 324) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21JLB102; 325) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21HLA932; 326) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21HLA289; 327) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21GLA459; 328) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21FLA151; 329) DYKMBNDL173A, UDI-DI: 10193489844276(each), 40193489844277(case), Lot Number: 21CLA355; 330) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 22HBR219; 331) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 22HBQ097; 332) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21LBJ741; 333) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21JBJ251; 334) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21FBS513; 335) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21DBV240; 336) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21BBG090; 337) DYKMBNDL175, UDI-DI: 10193489478341(each), 40193489478342(case), Lot Number: 21ABI988; 338) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21VBA119; 339) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21KBU588; 340) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21HBM091; 341) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21BBG047; 342) DYKMBNDL176, UDI-DI: 10193489477467(each), 40193489477468(case), Lot Number: 21ABI989; 343) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 24ABL746; 344) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23KBA265; 345) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23JBV751; 346) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23JBS636; 347) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23IBT885; 348) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23IBF611; 349) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23EBS911; 350) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23EBM441; 351) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 23DBN728; 352) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 22KBU993; 353) DYKMBNDL176A, UDI-DI: 10195327240585(each), 40195327240586(case), Lot Number: 22JBC617; 354) DYKMBNDL176B, UDI-DI: 10195327633790(each), 40195327633791(case), Lot Number: 24CBR360; 355) DYKMBNDL176C, UDI-DI: 10198459000454(each), 40198459000455(case), Lot Number: 25HBA827; 356) DYKMBNDL176C, UDI-DI: 10198459000454(each), 40198459000455(case), Lot Number: 25EBV419; 357) DYKMBNDL176C, UDI-DI: 10198459000454(each), 40198459000455(case), Lot Number: 25CB

Quantity Affected: 82597 units

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.

Distribution

Worldwide distribution - US Nationwide.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-01-07

Company

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 189 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medline Industries, LP) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Medline Industries, LP have FDA actions?

Medline Industries, LP has 442 FDA actions in our database, including 415 recalls and 27 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-1395-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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