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 DYNJ55252C, UDI/DI (EA)10195327267919, UDI/DI (CS)40195327267910; b) Model Number DYNJ55455A, UDI/DI (EA)10193489386233, UDI/DI (CS)40193489386234; c) Model Number DYNJ55680A, UDI/DI (EA)10889942639786, UDI/DI (CS)40889942639787; d) Model Number DYNJ56038A, UDI/DI (EA)10195327347840, UDI/DI (CS)40195327347841; e) Model Number DYNJ56547C, UDI/DI (EA)10193489879834, UDI/DI (CS)40193489879835; f) Model Number DYNJ57049G, UDI/DI (EA)10195327110390, UDI/DI (CS)40195327110391; g) Model Number DYNJ57049I, UDI/DI (EA)10195327207731, UDI/DI (CS)40195327207732; h) Model Number DYNJ57049J, UDI/DI (EA)10195327290658, UDI/DI (CS)40195327290659; i) Model Number DYNJ57645C, UDI/DI (EA)10195327287412, UDI/DI (CS)40195327287413; j) Model Number DYNJ57760C, UDI/DI (EA)10195327079390, UDI/DI (CS)40195327079391; k) Model Number DYNJ57792C, UDI/DI (EA)10195327209902, UDI/DI (CS)40195327209903; l) Model Number DYNJ58111D, UDI/DI (EA)10193489932928, UDI/DI (CS)40193489932929; m) Model Number DYNJ58111F, UDI/DI (EA)10195327223519, UDI/DI (CS)40195327223510; n) Model Number DYNJ58162, UDI/DI (EA)10889942829330, UDI/DI (CS)40889942829331; o) Model Number DYNJ58178B, UDI/DI (EA)10195327209919, UDI/DI (CS)40195327209910; p) Model Number DYNJ58510A, UDI/DI (EA)10193489817430, UDI/DI (CS)40193489817431; q) Model Number DYNJ59184B, UDI/DI (EA)10193489949100, UDI/DI (CS)40193489949101; r) Model Number DYNJ59307F, UDI/DI (EA)10195327058852, UDI/DI (CS)40195327058853; s) Model Number DYNJ59632D, UDI/DI (EA)10195327034078, UDI/DI (CS)40195327034079; t) Model Number DYNJ60112B, UDI/DI (EA)10195327118846, UDI/DI (CS)40195327118847; u) Model Number DYNJ60343B, UDI/DI (EA)10195327215491, UDI/DI (CS)40195327215492; v) Model Number DYNJ60343C, UDI/DI (EA)10195327285043, UDI/DI (CS)40195327285044; w) Model Number DYNJ60763, UDI/DI (EA)10193489527964, UDI/DI (CS)40193489527965; x) Model Number DYNJ61082C, UDI/DI (EA)10195327111410, UDI/DI (CS)40195327111411; y) Model Number DYNJ61082D, UDI/DI (EA)10195327261993, UDI/DI (CS)40195327261994; z) Model Number DYNJ61099B, UDI/DI (EA)10195327111854, UDI/DI (CS)40195327111855; aa) Model Number DYNJ61099C, UDI/DI (EA)10195327262006, UDI/DI (CS)40195327262007; bb) Model Number DYNJ61118C, UDI/DI (EA)10193489463972, UDI/DI (CS)40193489463973; cc) Model Number DYNJ61118D, UDI/DI (EA)10195327108212, UDI/DI (CS)40195327108213; dd) Model Number DYNJ61118F, UDI/DI (EA)10195327261986, UDI/DI (CS)40195327261987; ee) Model Number DYNJ61373A, UDI/DI (EA)10195327014698, UDI/DI (CS)40195327014699; ff) Model Number DYNJ61527A, UDI/DI (EA)10195327383800, UDI/DI (CS)40195327383801; gg) Model Number DYNJ61646A, UDI/DI (EA)10195327014315, UDI/DI (CS)40195327014316; hh) Model Number DYNJ62007A, UDI/DI (EA)10193489878905, UDI/DI (CS)40193489878906; ii) Model Number DYNJ62037D, UDI/DI (EA)10193489893694, UDI/DI (CS)40193489893695; jj) Model Number DYNJ62733A, UDI/DI (EA)10193489970678, UDI/DI (CS)40193489970679; kk) Model Number DYNJ63060B, UDI/DI (EA)10193489912821, UDI/DI (CS)40193489912822; ll) Model Number DYNJ63181A, UDI/DI (EA)10195327045487, UDI/DI (CS)40195327045488; mm) Model Number DYNJ63181B, UDI/DI (EA)10195327127213, UDI/DI (CS)40195327127214; nn) Model Number DYNJ63181C, UDI/DI (EA)10195327242008, UDI/DI (CS)40195327242009; oo) Model Number DYNJ64050A, UDI/DI (EA)10193489943825, UDI/DI (CS)40193489943826; pp) Model Number DYNJ64655C, UDI/DI (EA)10195327172893, UDI/DI (CS)40195327172894; qq) Model Number DYNJ64976, UDI/DI (EA)10193489237122, UDI/DI (CS)40193489237123; rr) Model Number DYNJ65174D, UDI/DI (EA)10193489962154, UDI/DI (CS)40193489962155; ss) Model Number DYNJ65190D, UDI/DI (EA)10195327066642, UDI/DI (CS)40195327066643; tt) Model Number DYNJ65190F, UDI/DI (EA)10195327092658, UDI/DI (CS)40195327092659; uu) Model Number DYNJ65481, UDI/DI (EA)10193489280463, UDI/DI (CS)40193489280464; vv) Model Number DYNJ65913, UDI/DI (EA)10193489303179, UDI/DI (CS)40193489303170; ww) Model Number DYNJ66166A, UDI/DI (EA)10193489395990, UDI/DI (CS)40193489395991; xx) Model Number DYNJ66182, UDI/DI (EA)10193489320985, UDI/DI (CS)40193489320986; yy) Model Number DYNJ66257, UDI/DI (EA)10193489325492, UDI/DI (CS)40193489325493; zz) Model Number DYNJ66257A, UDI/DI (EA)10193489947502, UDI/DI (CS)40193489947503; aaa) Model Number DYNJ66257B, UDI/DI (EA)10195327185831, UDI/DI (CS)40195327185832; bbb) Model Number DYNJ66259A, UDI/DI (EA)10195327185732, UDI/DI (CS)40195327185733; ccc) Model Number DYNJ66260A, UDI/DI (EA)10195327185749, UDI/DI (CS)40195327185740; ddd) Model Number DYNJ66473A, UDI/DI (EA)10193489917772, UDI/DI (CS)40193489917773; eee) Model Number DYNJ66476A, UDI/DI (EA)10195327051891, UDI/DI (CS)40195327051892; fff) Model Number DYNJ66515A, UDI/DI (EA)10193489406160, UDI/DI (CS)40193489406161; ggg) Model Number DYNJ66926A, UDI/DI (EA)10193489887358, UDI/DI (CS)40193489887359; hhh) Model Number DYNJ67136A, UDI/DI (EA)10193489935677, UDI/DI (CS)40193489935678; iii) Model Number DYNJ67144A, UDI/DI (EA)10195327179021, UDI/DI (CS)40195327179022; jjj) Model Number DYNJ67149A, UDI/DI (EA)10195327179038, UDI/DI (CS)40195327179039; kkk) Model Number DYNJ67174A, UDI/DI (EA)10195327046804, UDI/DI (CS)40195327046805; lll) Model Number DYNJ67174B, UDI/DI (EA)10195327131081, UDI/DI (CS)40195327131082; mmm) Model Number DYNJ67245A, UDI/DI (EA)10195327024253, UDI/DI (CS)40195327024254; nnn) Model Number DYNJ67245B, UDI/DI (EA)10195327292225, UDI/DI (CS)40195327292226; ooo) Model Number DYNJ67320A, UDI/DI (EA)10193489937572, UDI/DI (CS)40193489937573; ppp) Model Number DYNJ67737, UDI/DI (EA)10193489427752, UDI/DI (CS)40193489427753; qqq) Model Number DYNJ67990A, UDI/DI (EA)10195327265335, UDI/DI (CS)40195327265336; rrr) Model Number DYNJ68065B, UDI/DI (EA)10195327013332, UDI/DI (CS)40195327013333; sss) Model Number DYNJ68365B, UDI/DI (EA)10195327161934, UDI/DI (CS)40195327161935; ttt) Model Number DYNJ68538, UDI/DI (EA)10193489833119, UDI/DI (CS)40193489833110; uuu) Model Number DYNJ68729, UDI/DI (EA)10193489836547, UDI/DI (CS)40193489836548; vvv) Model Number DYNJ68729B, UDI/DI (EA)10195327020910, UDI/DI (CS)40195327020911; www) Model Number DYNJ68763, UDI/DI (EA)10193489837599, UDI/DI (CS)40193489837590; xxx) Model Number DYNJ68763A, UDI/DI (EA)10195327264789, UDI/DI (CS)40195327264780; yyy) Model Number DYNJ69056, UDI/DI (EA)10193489886870, UDI/DI (CS)40193489886871; zzz) Model Number DYNJ69056A, UDI/DI (EA)10195327061296, UDI/DI (CS)40195327061297; aaaa) Model Number DYNJ69200, UDI/DI (EA)10193489906813, UDI/DI (CS)40193489906814; bbbb) Model Number DYNJ69298, UDI/DI (EA)10193489925418, UDI/DI (CS)40193489925419; cccc) Model Number DYNJ69421, UDI/DI (EA)10193489937596, UDI/DI (CS)40193489937597; dddd) Model Number DYNJ69691, UDI/DI (EA)10193489970111, UDI/DI (CS)40193489970112; eeee) Model Number DYNJ69742B, UDI/DI (EA)10195327136888, UDI/DI (CS)40195327136889; ffff) Model Number DYNJ69763A, UDI/DI (EA)10195327330019, UDI/DI (CS)40195327330010; gggg) Model Number DYNJ69864, UDI/DI (EA)10193489990485, UDI/DI (CS)40193489990486; hhhh) Model Number DYNJ69944, UDI/DI (EA)10193489998450, UDI/DI (CS)40193489998451; iiii) Model Number DYNJ69944A, UDI/DI (EA)10195327285364, UDI/DI (CS)40195327285365; jjjj) Model Number DYNJ69951, UDI/DI (EA)10195327000301, UDI/DI (CS)40195327000302; kkkk) Model Number DYNJ80269, UDI/DI (EA)10195327017804, UDI/DI (CS)40195327017805; llll) Model Number DYNJ80297, UDI/DI (EA)10195327021771, UDI/DI (CS)40195327021772; mmmm) Model Number DYNJ80297A, UDI/DI (EA)10195327372170, UDI/DI (CS)40195327372171; nnnn) Model Number DYNJ81213, UDI/DI (EA)10195327094270, UDI/DI (CS)40195327094271; oooo) Model Number DYNJ81213A, UDI/DI (EA)10195327319250, UDI/DI (CS)40195327319251; pppp) Model Number DYNJ81316, UDI/DI (EA)10195327103798, UDI/DI (CS)40195327103799; qqqq) Model Number DYNJ81429A, UDI/DI (EA)10195327321642, UDI/DI (CS)40195327321643; rrrr) Model Number DYNJ81435B, UDI/DI (EA)10195327324834, UDI/DI (CS)40195327324835; ssss) Model Number DYNJ82030, UDI/DI (EA)10195327162375, UDI/DI (CS)40195327162376; tttt) Model Number DYNJ82041, UDI/DI (EA)10195327162214, UDI/DI (CS)40195327162215; uuuu) Model Number DYNJ82079, UDI/DI (EA)10195327167363, UDI/DI (CS)40195327167364; vvvv) Model Number DYNJ82280, UDI/DI (EA)10195327183929, UDI/DI (CS)40195327183920; wwww) Model Number DYNJ82296, UDI/DI (EA)10195327184209, UDI/DI (CS)40195327184200; xxxx) Model Number DYNJ82999, UDI/DI (EA)10195327223106, UDI/DI (CS)40195327223107; yyyy) Model Number DYNJ82999A, UDI/DI (EA)10195327310271, UDI/DI (CS)40195327310272; zzzz) Model Number DYNJ83089, UDI/DI (EA)10195327230838, UDI/DI (CS)40195327230839;

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) CATH LAB PACK…

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Quantity

3,740,814 units in 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)