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 Numbers DYNJ67770A, UDI/DI (EA)10195327290979, UDI/DI (CS)40195327290970; b) Model Numbers DYNJ67771, UDI/DI (EA)10193489430721, UDI/DI (CS)40193489430722; c) Model Numbers DYNJ68019, UDI/DI (EA)10193489467840, UDI/DI (CS)40193489467841; d) Model Numbers DYNJ68198, UDI/DI (EA)10193489499179, UDI/DI (CS)40193489499170; e) Model Numbers DYNJ68499B, UDI/DI (EA)10195327034054, UDI/DI (CS)40195327034055; f) Model Numbers DYNJ68667, UDI/DI (EA)10193489837315, UDI/DI (CS)40193489837316; g) Model Numbers DYNJ68863, UDI/DI (EA)10193489845402, UDI/DI (CS)40193489845403; h) Model Numbers DYNJ68880, UDI/DI (EA)10193489847727, UDI/DI (CS)40193489847728; i) Model Numbers DYNJ68933, UDI/DI (EA)10193489860375, UDI/DI (CS)40193489860376; j) Model Numbers DYNJ68968A, UDI/DI (EA)10195327206840, UDI/DI (CS)40195327206841; k) Model Numbers DYNJ68990A, UDI/DI (EA)10193489981360, UDI/DI (CS)40193489981361; l) Model Numbers DYNJ69009A, UDI/DI (EA)10195327075569, UDI/DI (CS)40195327075560; m) Model Numbers DYNJ69108A, UDI/DI (EA)10195327025717, UDI/DI (CS)40195327025718; n) Model Numbers DYNJ69272A, UDI/DI (EA)10195327015800, UDI/DI (CS)40195327015801; o) Model Numbers DYNJ69302, UDI/DI (EA)10193489926279, UDI/DI (CS)40193489926270; p) Model Numbers DYNJ69422, UDI/DI (EA)10193489937541, UDI/DI (CS)40193489937542; q) Model Numbers DYNJ69622, UDI/DI (EA)10193489959581, UDI/DI (CS)40193489959582; r) Model Numbers DYNJ69624, UDI/DI (EA)10193489959567, UDI/DI (CS)40193489959568; s) Model Numbers DYNJ69626, UDI/DI (EA)10193489960693, UDI/DI (CS)40193489960694; t) Model Numbers DYNJ69682, UDI/DI (EA)10193489968927, UDI/DI (CS)40193489968928; u) Model Numbers DYNJ69691A, UDI/DI (EA)10195327070267, UDI/DI (CS)40195327070268; v) Model Numbers DYNJ69943A, UDI/DI (EA)10195327284633, UDI/DI (CS)40195327284634; w) Model Numbers DYNJ80199A, UDI/DI (EA)10195327040864, UDI/DI (CS)40195327040865; x) Model Numbers DYNJ80199B, UDI/DI (EA)10195327088200, UDI/DI (CS)40195327088201; y) Model Numbers DYNJ80310, UDI/DI (EA)10195327023201, UDI/DI (CS)40195327023202; z) Model Numbers DYNJ80346A, UDI/DI (EA)10195327166250, UDI/DI (CS)40195327166251; aa) Model Numbers DYNJ80489, UDI/DI (EA)10195327045845, UDI/DI (CS)40195327045846; bb) Model Numbers DYNJ80506, UDI/DI (EA)10195327049171, UDI/DI (CS)40195327049172; cc) Model Numbers DYNJ80868, UDI/DI (EA)10195327082505, UDI/DI (CS)40195327082506; dd) Model Numbers DYNJ81022, UDI/DI (EA)10195327082789, UDI/DI (CS)40195327082780; ee) Model Numbers DYNJ81023, UDI/DI (EA)10195327082796, UDI/DI (CS)40195327082797; ff) Model Numbers DYNJ81033, UDI/DI (EA)10195327082987, UDI/DI (CS)40195327082988; gg) Model Numbers DYNJ81095, UDI/DI (EA)10195327084127, UDI/DI (CS)40195327084128; hh) Model Numbers DYNJ81200, UDI/DI (EA)10195327091699, UDI/DI (CS)40195327091690; ii) Model Numbers DYNJ81200A, UDI/DI (EA)10195327224714, UDI/DI (CS)40195327224715; jj) Model Numbers DYNJ81320, UDI/DI (EA)10195327110147, UDI/DI (CS)40195327110148; kk) Model Numbers DYNJ81462A, UDI/DI (EA)10195327378615, UDI/DI (CS)40195327378616; ll) Model Numbers DYNJ81592A, UDI/DI (EA)10195327315054, UDI/DI (CS)40195327315055; mm) Model Numbers DYNJ81592B, UDI/DI (EA)10195327398309, UDI/DI (CS)40195327398300; nn) Model Numbers DYNJ81605, UDI/DI (EA)10195327123888, UDI/DI (CS)40195327123889; oo) Model Numbers DYNJ81610, UDI/DI (EA)10195327123949, UDI/DI (CS)40195327123940; pp) Model Numbers DYNJ81610A, UDI/DI (EA)10195327315047, UDI/DI (CS)40195327315048; qq) Model Numbers DYNJ81610B, UDI/DI (EA)10195327398316, UDI/DI (CS)40195327398317; rr) Model Numbers DYNJ81618, UDI/DI (EA)10195327124601, UDI/DI (CS)40195327124602; ss) Model Numbers DYNJ81626, UDI/DI (EA)10195327127060, UDI/DI (CS)40195327127061; tt) Model Numbers DYNJ81626A, UDI/DI (EA)10195327297190, UDI/DI (CS)40195327297191; uu) Model Numbers DYNJ81642, UDI/DI (EA)10195327129668, UDI/DI (CS)40195327129669; vv) Model Numbers DYNJ81642A, UDI/DI (EA)10195327266387, UDI/DI (CS)40195327266388; ww) Model Numbers DYNJ81705, UDI/DI (EA)10195327135577, UDI/DI (CS)40195327135578; xx) Model Numbers DYNJ81716, UDI/DI (EA)10195327138066, UDI/DI (CS)40195327138067; yy) Model Numbers DYNJ81716A, UDI/DI (EA)10195327203856, UDI/DI (CS)40195327203857; zz) Model Numbers DYNJ81716B, UDI/DI (EA)10195327277260, UDI/DI (CS)40195327277261; aaa) Model Numbers DYNJ82104, UDI/DI (EA)10195327171087, UDI/DI (CS)40195327171088; bbb) Model Numbers DYNJ82109, UDI/DI (EA)10195327171247, UDI/DI (CS)40195327171248; ccc) Model Numbers DYNJ82144, UDI/DI (EA)10195327178031, UDI/DI (CS)40195327178032; ddd) Model Numbers DYNJ82314, UDI/DI (EA)10195327184216, UDI/DI (CS)40195327184217; eee) Model Numbers DYNJ82372, UDI/DI (EA)10195327187538, UDI/DI (CS)40195327187539; fff) Model Numbers DYNJ82711, UDI/DI (EA)10195327203627, UDI/DI (CS)40195327203628; ggg) Model Numbers DYNJ82858A, UDI/DI (EA)10195327244897, UDI/DI (CS)40195327244898; hhh) Model Numbers DYNJ82859A, UDI/DI (EA)10195327244903, UDI/DI (CS)40195327244904; iii) Model Numbers DYNJ82987, UDI/DI (EA)10195327222116, UDI/DI (CS)40195327222117; jjj) Model Numbers DYNJ82988, UDI/DI (EA)10195327222208, UDI/DI (CS)40195327222209; kkk) Model Numbers DYNJ82988A, UDI/DI (EA)10195327293314, UDI/DI (CS)40195327293315; lll) Model Numbers DYNJ83051, UDI/DI (EA)10195327245283, UDI/DI (CS)40195327245284; mmm) Model Numbers DYNJ83146, UDI/DI (EA)10195327235680, UDI/DI (CS)40195327235681; nnn) Model Numbers DYNJ83147, UDI/DI (EA)10195327235505, UDI/DI (CS)40195327235506; ooo) Model Numbers DYNJ83161, UDI/DI (EA)10195327237837, UDI/DI (CS)40195327237838; ppp) Model Numbers DYNJ83432, UDI/DI (EA)10195327266530, UDI/DI (CS)40195327266531; qqq) Model Numbers DYNJ83461, UDI/DI (EA)10195327267797, UDI/DI (CS)40195327267798; rrr) Model Numbers DYNJ83490, UDI/DI (EA)10195327271411, UDI/DI (CS)40195327271412; sss) Model Numbers DYNJ83606, UDI/DI (EA)10195327284855, UDI/DI (CS)40195327284856; ttt) Model Numbers DYNJ83624, UDI/DI (EA)10195327285869, UDI/DI (CS)40195327285860; uuu) Model Numbers DYNJ83972, UDI/DI (EA)10195327322694, UDI/DI (CS)40195327322695; vvv) Model Numbers DYNJ84130, UDI/DI (EA)10195327334550, UDI/DI (CS)40195327334551; www) Model Numbers DYNJ84252, UDI/DI (EA)10195327345570, UDI/DI (CS)40195327345571; xxx) Model Numbers DYNJ901075O, UDI/DI (EA)10195327052683, UDI/DI (CS)40195327052684; yyy) Model Numbers DYNJ901075P, UDI/DI (EA)10195327253554, UDI/DI (CS)40195327253555; zzz) Model Numbers DYNJ901745K, UDI/DI (EA)10193489482232, UDI/DI (CS)40193489482233; aaaa) Model Numbers DYNJ902259B, UDI/DI (EA)10193489919714, UDI/DI (CS)40193489919715; bbbb) Model Numbers DYNJ902261G, UDI/DI (EA)10193489919721, UDI/DI (CS)40193489919722; cccc) Model Numbers DYNJ902704P, UDI/DI (EA)10193489863376, UDI/DI (CS)40193489863377; dddd) Model Numbers DYNJ903451D, UDI/DI (EA)10193489667851, UDI/DI (CS)40193489667852; eeee) Model Numbers DYNJ903919J, UDI/DI (EA)10195327045906, UDI/DI (CS)40195327045907; ffff) Model Numbers DYNJ903919K, UDI/DI (EA)10195327218782, UDI/DI (CS)40195327218783; gggg) Model Numbers DYNJ903919L, UDI/DI (EA)10195327267056, UDI/DI (CS)40195327267057; hhhh) Model Numbers DYNJ904171F, UDI/DI (EA)10193489439243, UDI/DI (CS)40193489439244; iiii) Model Numbers DYNJ904401C, UDI/DI (EA)10193489348910, UDI/DI (CS)40193489348911; jjjj) Model Numbers DYNJ904984B, UDI/DI (EA)10193489812930, UDI/DI (CS)40193489812931; kkkk) Model Numbers DYNJ905079F, UDI/DI (EA)10195327209001, UDI/DI (CS)40195327209002; llll) Model Numbers DYNJ905285C, UDI/DI (EA)10193489947250, UDI/DI (CS)40193489947251; mmmm) Model Numbers DYNJ905291B, UDI/DI (EA)10193489950373, UDI/DI (CS)40193489950374; nnnn) Model Numbers DYNJ905291C, UDI/DI (EA)10195327062545, UDI/DI (CS)40195327062546; oooo) Model Numbers DYNJ905311I, UDI/DI (EA)10195327146214, UDI/DI (CS)40195327146215; pppp) Model Numbers DYNJ905516C, UDI/DI (EA)10193489967128, UDI/DI (CS)40193489967129; qqqq) Model Numbers DYNJ905516D, UDI/DI (EA)10195327147839, UDI/DI (CS)40195327147830; rrrr) Model Numbers DYNJ905516F, UDI/DI (EA)10195327247577, UDI/DI (CS)40195327247578; ssss) Model Numbers DYNJ905726C, UDI/DI (EA)10193489943375, UDI/DI (CS)40193489943376; tttt) Model Numbers DYNJ905726D, UDI/DI (EA)10195327161514, UDI/DI (CS)40195327161515; uuuu) Model Numbers DYNJ905744C, UDI/DI (EA)10195327162313, UDI/DI (CS)40195327162314; vvvv) Model Numbers DYNJ905859B, UDI/DI (EA)10193489417869, UDI/DI (CS)40193489417860; wwww) Model Numbers DYNJ905884A, UDI/DI (EA)10193489795448, UDI/DI (CS)40193489795449; xxxx) Model Numbers DYNJ906086B, UDI/DI (EA)10195327046354, UDI/DI (CS)40195327046355; yyyy) Model Numbers DYNJ906098A, UDI/DI (EA)10193489209457, UDI/DI (CS)40193489209458; zzzz) Model Numbers DYNJ906102F, UDI/DI (EA)10195327028268, UDI/DI (CS)40195327028269;

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP PROCEDURE PACK…

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)