Medline Probe Cover Kits containing sterile Ultrasound recall

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?

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNJ55841B, UDI/DI (EA) 10888277757684, UDI/DI (CS) 40888277757685; b) Model Number DYNJ55954B, UDI/DI (EA) 10193489214239, UDI/DI (CS) 40193489214230; c) Model Number DYNJ56140B, UDI/DI (EA) 10193489547672, UDI/DI (CS) 40193489547673; d) Model Number DYNJ56260B, UDI/DI (EA) 10193489569827, UDI/DI (CS) 40193489569828; e) Model Number DYNJ56392, UDI/DI (EA) 10889942640676, UDI/DI (CS) 40889942640677; f) Model Number DYNJ56392A, UDI/DI (EA) 10195327261405, UDI/DI (CS) 40195327261406; g) Model Number DYNJ56392B, UDI/DI (EA) 10195327323677, UDI/DI (CS) 40195327323678; h) Model Number DYNJ56507B, UDI/DI (EA) 10193489443479, UDI/DI (CS) 40193489443470; i) Model Number DYNJ56548B, UDI/DI (EA) 10193489813180, UDI/DI (CS) 40193489813181; j) Model Number DYNJ57149, UDI/DI (EA) 10889942721603, UDI/DI (CS) 40889942721604; k) Model Number DYNJ57303B, UDI/DI (EA) 10193489360646, UDI/DI (CS) 40193489360647; l) Model Number DYNJ57514, UDI/DI (EA) 10889942747849, UDI/DI (CS) 40889942747840; m) Model Number DYNJ57594A, UDI/DI (EA) 10889942963218, UDI/DI (CS) 40889942963219; n) Model Number DYNJ57736A, UDI/DI (EA) 10888277779709, UDI/DI (CS) 40888277779700; o) Model Number DYNJ57793, UDI/DI (EA) 10889942819164, UDI/DI (CS) 40889942819165; p) Model Number DYNJ58160, UDI/DI (EA) 10889942828647, UDI/DI (CS) 40889942828648; q) Model Number DYNJ58228, UDI/DI (EA) 10889942835492, UDI/DI (CS) 40889942835493; r) Model Number DYNJ58304, UDI/DI (EA) 10889942843732, UDI/DI (CS) 40889942843733; s) Model Number DYNJ58424, UDI/DI (EA) 10889942851836, UDI/DI (CS) 40889942851837; t) Model Number DYNJ58643A, UDI/DI (EA) 10193489809213, UDI/DI (CS) 40193489809214; u) Model Number DYNJ59062, UDI/DI (EA) 10889942941650, UDI/DI (CS) 40889942941651; v) Model Number DYNJ59067, UDI/DI (EA) 10889942930043, UDI/DI (CS) 40889942930044; w) Model Number DYNJ59085, UDI/DI (EA) 10889942932016, UDI/DI (CS) 40889942932017; x) Model Number DYNJ59094, UDI/DI (EA) 10889942933501, UDI/DI (CS) 40889942933502; y) Model Number DYNJ59206, UDI/DI (EA) 10888277765573, UDI/DI (CS) 40888277765574; z) Model Number DYNJ59246, UDI/DI (EA) 10888277767294, UDI/DI (CS) 40888277767295; aa) Model Number DYNJ59377, UDI/DI (EA) 10888277736290, UDI/DI (CS) 40888277736291; bb) Model Number DYNJ59392C, UDI/DI (EA) 10193489282245, UDI/DI (CS) 40193489282246; cc) Model Number DYNJ59631, UDI/DI (EA) 10888277764026, UDI/DI (CS) 40888277764027; dd) Model Number DYNJ59795A, UDI/DI (EA) 10193489566987, UDI/DI (CS) 40193489566988; ee) Model Number DYNJ60126A, UDI/DI (EA) 10193489247084, UDI/DI (CS) 40193489247085; ff) Model Number DYNJ60127A, UDI/DI (EA) 10193489729047, UDI/DI (CS) 40193489729048; gg) Model Number DYNJ60128A, UDI/DI (EA) 10193489544510, UDI/DI (CS) 40193489544511; hh) Model Number DYNJ60343A, UDI/DI (EA) 10193489573831, UDI/DI (CS) 40193489573832; ii) Model Number DYNJ60804, UDI/DI (EA) 10193489532784, UDI/DI (CS) 40193489532785; jj) Model Number DYNJ61067, UDI/DI (EA) 10193489542226, UDI/DI (CS) 40193489542227; kk) Model Number DYNJ61099A, UDI/DI (EA) 10193489463965, UDI/DI (CS) 40193489463966; ll) Model Number DYNJ61243, UDI/DI (EA) 10193489550917, UDI/DI (CS) 40193489550918; mm) Model Number DYNJ61264, UDI/DI (EA) 10193489554472, UDI/DI (CS) 40193489554473; nn) Model Number DYNJ61433, UDI/DI (EA) 10193489565171, UDI/DI (CS) 40193489565172; oo) Model Number DYNJ61517, UDI/DI (EA) 10193489577570, UDI/DI (CS) 40193489577571; pp) Model Number DYNJ62295, UDI/DI (EA) 10193489641165, UDI/DI (CS) 40193489641166; qq) Model Number DYNJ62295A, UDI/DI (EA) 10193489845952, UDI/DI (CS) 40193489845953; rr) Model Number DYNJ62295B, UDI/DI (EA) 10195327209933, UDI/DI (CS) 40195327209934; ss) Model Number DYNJ62434A, UDI/DI (EA) 10193489366273, UDI/DI (CS) 40193489366274; tt) Model Number DYNJ62540, UDI/DI (EA) 10193489666472, UDI/DI (CS) 40193489666473; uu) Model Number DYNJ62588, UDI/DI (EA) 10193489669831, UDI/DI (CS) 40193489669832; vv) Model Number DYNJ63268B, UDI/DI (EA) 10193489305111, UDI/DI (CS) 40193489305112; ww) Model Number DYNJ63340, UDI/DI (EA) 10193489741162, UDI/DI (CS) 40193489741163; xx) Model Number DYNJ63354C, UDI/DI (EA) 10195327273255, UDI/DI (CS) 40195327273256; yy) Model Number DYNJ63576A, UDI/DI (EA) 10193489429251, UDI/DI (CS) 40193489429252; zz) Model Number DYNJ63892, UDI/DI (EA) 10193489771435, UDI/DI (CS) 40193489771436; aaa) Model Number DYNJ64068, UDI/DI (EA) 10193489783131, UDI/DI (CS) 40193489783132; bbb) Model Number DYNJ64075A, UDI/DI (EA) 10193489231328, UDI/DI (CS) 40193489231329; ccc) Model Number DYNJ64336, UDI/DI (EA) 10193489801873, UDI/DI (CS) 40193489801874; ddd) Model Number DYNJ64372A, UDI/DI (EA) 10193489884685, UDI/DI (CS) 40193489884686; eee) Model Number DYNJ64393, UDI/DI (EA) 10193489809633, UDI/DI (CS) 40193489809634; fff) Model Number DYNJ64439, UDI/DI (EA) 10193489200485, UDI/DI (CS) 40193489200486; ggg) Model Number DYNJ64666A, UDI/DI (EA) 10193489317268, UDI/DI (CS) 40193489317269; hhh) Model Number DYNJ64928A, UDI/DI (EA) 10195327329815, UDI/DI (CS) 40195327329816; iii) Model Number DYNJ64930, UDI/DI (EA) 10193489231687, UDI/DI (CS) 40193489231688; jjj) Model Number DYNJ65189C, UDI/DI (EA) 10195327072001, UDI/DI (CS) 40195327072002; kkk) Model Number DYNJ65488B, UDI/DI (EA) 10193489443646, UDI/DI (CS) 40193489443647; lll) Model Number DYNJ65995, UDI/DI (EA) 10193489311549, UDI/DI (CS) 40193489311540; mmm) Model Number DYNJ65995A, UDI/DI (EA) 10195327068127, UDI/DI (CS) 40195327068128; nnn) Model Number DYNJ66005, UDI/DI (EA) 10193489312546, UDI/DI (CS) 40193489312547; ooo) Model Number DYNJ66065, UDI/DI (EA) 10193489319187, UDI/DI (CS) 40193489319188; ppp) Model Number DYNJ66258, UDI/DI (EA) 10193489325478, UDI/DI (CS) 40193489325479; qqq) Model Number DYNJ66258A, UDI/DI (EA) 10195327194239, UDI/DI (CS) 40195327194230; rrr) Model Number DYNJ66260, UDI/DI (EA) 10193489325461, UDI/DI (CS) 40193489325462; sss) Model Number DYNJ66620A, UDI/DI (EA) 10193489914245, UDI/DI (CS) 40193489914246; ttt) Model Number DYNJ66741, UDI/DI (EA) 10193489374940, UDI/DI (CS) 40193489374941; uuu) Model Number DYNJ67414, UDI/DI (EA) 10193489964646, UDI/DI (CS) 40193489964647; vvv) Model Number DYNJ67487A, UDI/DI (EA) 10193489888997, UDI/DI (CS) 40193489888998; www) Model Number DYNJ67504A, UDI/DI (EA) 10195327009618, UDI/DI (CS) 40195327009619; xxx) Model Number DYNJ67504B, UDI/DI (EA) 10195327331023, UDI/DI (CS) 40195327331024; yyy) Model Number DYNJ67899, UDI/DI (EA) 10193489454499, UDI/DI (CS) 40193489454490; zzz) Model Number DYNJ68027, UDI/DI (EA) 10193489469158, UDI/DI (CS) 40193489469159; aaaa) Model Number DYNJ68923A, UDI/DI (EA) 10195327070793, UDI/DI (CS) 40195327070794; bbbb) Model Number DYNJ68968, UDI/DI (EA) 10193489870398, UDI/DI (CS) 40193489870399; cccc) Model Number DYNJ68990, UDI/DI (EA) 10193489872613, UDI/DI (CS) 40193489872614; dddd) Model Number DYNJ69017, UDI/DI (EA) 10193489878158, UDI/DI (CS) 40193489878159; eeee) Model Number DYNJ69619, UDI/DI (EA) 10193489959444, UDI/DI (CS) 40193489959445; ffff) Model Number DYNJ69716A, UDI/DI (EA) 10195327250577, UDI/DI (CS) 40195327250578; gggg) Model Number DYNJ69820, UDI/DI (EA) 10193489981438, UDI/DI (CS) 40193489981439; hhhh) Model Number DYNJ80299, UDI/DI (EA) 10195327021931, UDI/DI (CS) 40195327021932; iiii) Model Number DYNJ81343, UDI/DI (EA) 10195327113063, UDI/DI (CS) 40195327113064; jjjj) Model Number DYNJ83152, UDI/DI (EA) 10195327237080, UDI/DI (CS) 40195327237081; kkkk) Model Number DYNJ83524, UDI/DI (EA) 10195327273491, UDI/DI (CS) 40195327273492; llll) Model Number DYNJ83931, UDI/DI (EA) 10195327315351, UDI/DI (CS) 40195327315352; mmmm) Model Number DYNJ83976, UDI/DI (EA) 10195327323196, UDI/DI (CS) 40195327323197; nnnn) Model Number DYNJ84172, UDI/DI (EA) 10195327338909, UDI/DI (CS) 40195327338900; oooo) Model Number DYNJ901348D, UDI/DI (EA) 10193489594683, UDI/DI (CS) 40193489594684; pppp) Model Number DYNJ901392D, UDI/DI (EA) 10193489539516, UDI/DI (CS) 40193489539517; qqqq) Model Number DYNJ902168D, UDI/DI (EA) 10193489866155, UDI/DI (CS) 40193489866156; rrrr) Model Number DYNJ902281, UDI/DI (EA) 10888277981416, UDI/DI (CS) 40888277981417; ssss) Model Number DYNJ905002A, UDI/DI (EA) 10889942911653, UDI/DI (CS) 40889942911654; tttt) Model Number DYNJ905335, UDI/DI (EA) 10889942875894, UDI/DI (CS) 40889942875895; uuuu) Model Number DYNJ905651B, UDI/DI (EA) 10193489925067, UDI/DI (CS) 40193489925068; vvvv) Model Number DYNJ905936B, UDI/DI (EA) 10193489422818, UDI/DI (CS) 40193489422819; wwww) Model Number DYNJ908752, UDI/DI (EA) 10195327171360, UDI/DI (CS) 40195327171361; xxxx) Model Number DYNJRA0585, UDI/DI (EA) 10888277580695, UDI/DI (CS) 40888277580696; yyyy) Model Number DYNJRA1155B, UDI/DI (EA) 10193489583717, UDI/DI (CS) 40193489583718; zzzz) Model Number DYNJRA1578, UDI/DI (EA) 10193489272789, UDI/DI (CS) 40193489272780;

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VEIN KIT, Model Number DYNJ55841B; b) FACELIFT PACK, Model…

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Quantity

# included in 3,740,814 units total

Distribution

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Recall date

July 26, 2023

Classification

Class II

Status

Ongoing

Agency

FDA (device)