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 ARTNC115, UDI/DI (EA) 10653160354338, UDI/DI (CS) 40653160354339; b) Model Number CDS980752I, UDI/DI (EA) 10889942428540, UDI/DI (CS) 40889942428541; c) Model Number CDS982858F, UDI/DI (EA) 10888277739215, UDI/DI (CS) 40888277739216; d) Model Number CDS982859F, UDI/DI (EA) 10888277739208, UDI/DI (CS) 40888277739209; e) Model Number CDS983082J, UDI/DI (EA) 10193489674514, UDI/DI (CS) 40193489674515; f) Model Number CDS983704I, UDI/DI (EA) 10193489854558, UDI/DI (CS) 40193489854559; g) Model Number CVI4340, UDI/DI (EA) 10653160309475, UDI/DI (CS) 40653160309476; h) Model Number CVI4765, UDI/DI (EA) 10193489953183, UDI/DI (CS) 40193489953184; i) Model Number DYND2673B, UDI/DI (EA) 10193489564358, UDI/DI (CS) 40193489564359; j) Model Number DYNDA1468C, UDI/DI (EA) 10889942843176, UDI/DI (CS) 40889942843177; k) Model Number DYNDA2011B, UDI/DI (EA) 10193489533026, UDI/DI (CS) 40193489533027; l) Model Number DYNDA2076, UDI/DI (EA) 10889942708505, UDI/DI (CS) 40889942708506; m) Model Number DYNDA2148A, UDI/DI (EA) 10888277734036, UDI/DI (CS) 40888277734037; n) Model Number DYNDA2365B, UDI/DI (EA) 10193489836448, UDI/DI (CS) 40193489836449; o) Model Number DYNDC2099, UDI/DI (EA) 10888277295674, UDI/DI (CS) 40888277295675; p) Model Number DYNDC2399A, UDI/DI (EA) 10889942446933, UDI/DI (CS) 40889942446934; q) Model Number DYNDH1165A, UDI/DI (EA) 10889942611508, UDI/DI (CS) 40889942611509; r) Model Number DYNDH1204, UDI/DI (EA) 10889942519835, UDI/DI (CS) 40889942519836; s) Model Number DYNDH1292, UDI/DI (EA) 10889942742233, UDI/DI (CS) 40889942742234; t) Model Number DYNDH1319, UDI/DI (EA) 10889942795475, UDI/DI (CS) 40889942795476; u) Model Number DYNDH1470B, UDI/DI (EA) 10193489111248, UDI/DI (CS) 40193489111249; v) Model Number DYNDH1470C, UDI/DI (EA) 10195327297718, UDI/DI (CS) 40195327297719; w) Model Number DYNDH1492, UDI/DI (EA) 10193489434460, UDI/DI (CS) 40193489434461; x) Model Number DYNDH1649, UDI/DI (EA) 10193489944365, UDI/DI (CS) 40193489944366; y) Model Number DYNDL1596A, UDI/DI (EA) 10884389926505, UDI/DI (CS) 40884389926506; z) Model Number DYNDV2038B, UDI/DI (EA) 10193489919837, UDI/DI (CS) 40193489919838; aa) Model Number DYNDV2385A, UDI/DI (EA) 10195327298760, UDI/DI (CS) 40195327298761; bb) Model Number DYNJ00281N, UDI/DI (EA) 10193489449808, UDI/DI (CS) 40193489449809; cc) Model Number DYNJ01964M, UDI/DI (EA) 10193489648034, UDI/DI (CS) 40193489648035; dd) Model Number DYNJ0248546D, UDI/DI (EA) 10195327069285, UDI/DI (CS) 40195327069286; ee) Model Number DYNJ0309084D, UDI/DI (EA) 10889942885268, UDI/DI (CS) 40889942885269; ff) Model Number DYNJ0351069, UDI/DI (EA) 10889942059058, UDI/DI (CS) 40889942059059; gg) Model Number DYNJ0370436Q, UDI/DI (EA) 10888277779280, UDI/DI (CS) 40888277779281; hh) Model Number DYNJ0416535Y, UDI/DI (EA) 10193489994056, UDI/DI (CS) 40193489994057; ii) Model Number DYNJ0530948AR, UDI/DI (EA) 10195327141882, UDI/DI (CS) 40195327141883; jj) Model Number DYNJ0586030P, UDI/DI (EA) 10889942947140, UDI/DI (CS) 40889942947141; kk) Model Number DYNJ0604508Q, UDI/DI (EA) 10193489560190, UDI/DI (CS) 40193489560191; ll) Model Number DYNJ0604540P, UDI/DI (EA) 10193489560206, UDI/DI (CS) 40193489560207; mm) Model Number DYNJ0604540Q, UDI/DI (EA) 10193489839685, UDI/DI (CS) 40193489839686; nn) Model Number DYNJ0747885F, UDI/DI (EA) 10193489542318, UDI/DI (CS) 40193489542319; oo) Model Number DYNJ0774759O, UDI/DI (EA) 10195327091859, UDI/DI (CS) 40195327091850; pp) Model Number DYNJ0774759P, UDI/DI (EA) 10195327246136, UDI/DI (CS) 40195327246137; qq) Model Number DYNJ0785821N, UDI/DI (EA) 10193489915792, UDI/DI (CS) 40193489915793; rr) Model Number DYNJ0785821O, UDI/DI (EA) 10195327263737, UDI/DI (CS) 40195327263738; ss) Model Number DYNJ0807503M, UDI/DI (EA) 10889942091737, UDI/DI (CS) 40889942091738; tt) Model Number DYNJ0931376F, UDI/DI (EA) 10193489271508, UDI/DI (CS) 40193489271509; uu) Model Number DYNJ0952428, UDI/DI (EA) 10889942101610, UDI/DI (CS) 40889942101611; vv) Model Number DYNJ20094K, UDI/DI (EA) 10193489213256, UDI/DI (CS) 40193489213257; ww) Model Number DYNJ31934D, UDI/DI (EA) 10195327071509, UDI/DI (CS) 40195327071500; xx) Model Number DYNJ32397B, UDI/DI (EA) 10884389916650, UDI/DI (CS) 40884389916651; yy) Model Number DYNJ35524D, UDI/DI (EA) 10193489766103, UDI/DI (CS) 40193489766104; zz) Model Number DYNJ35574A, UDI/DI (EA) 10884389538067, UDI/DI (CS) 40884389538068; aaa) Model Number DYNJ35988J, UDI/DI (EA) 10195327024666, UDI/DI (CS) 40195327024667; bbb) Model Number DYNJ35989G, UDI/DI (EA) 10195327024673, UDI/DI (CS) 40195327024674; ccc) Model Number DYNJ36814B, UDI/DI (EA) 10195327075576, UDI/DI (CS) 40195327075577; ddd) Model Number DYNJ37280C, UDI/DI (EA) 10889942431656, UDI/DI (CS) 40889942431657; eee) Model Number DYNJ37460A, UDI/DI (EA) 10888277560437, UDI/DI (CS) 40888277560438; fff) Model Number DYNJ38326F, UDI/DI (EA) 10193489236675, UDI/DI (CS) 40193489236676; ggg) Model Number DYNJ38563O, UDI/DI (EA) 10193489251746, UDI/DI (CS) 40193489251747; hhh) Model Number DYNJ38682C, UDI/DI (EA) 10889942897193, UDI/DI (CS) 40889942897194; iii) Model Number DYNJ38714B, UDI/DI (EA) 10889942601936, UDI/DI (CS) 40889942601937; jjj) Model Number DYNJ39885A, UDI/DI (EA) 10889942539932, UDI/DI (CS) 40889942539933; kkk) Model Number DYNJ40306A, UDI/DI (EA) 10889942601929, UDI/DI (CS) 40889942601920; lll) Model Number DYNJ40374A, UDI/DI (EA) 10888277557949, UDI/DI (CS) 40888277557940; mmm) Model Number DYNJ41137B, UDI/DI (EA) 10889942260874, UDI/DI (CS) 40889942260875; nnn) Model Number DYNJ41873B, UDI/DI (EA) 10193489563061, UDI/DI (CS) 40193489563062; ooo) Model Number DYNJ41875B, UDI/DI (EA) 10193489563078, UDI/DI (CS) 40193489563079; ppp) Model Number DYNJ42172A, UDI/DI (EA) 10193489502718, UDI/DI (CS) 40193489502719; qqq) Model Number DYNJ42691, UDI/DI (EA) 10888277003507, UDI/DI (CS) 40888277003508; rrr) Model Number DYNJ42913, UDI/DI (EA) 10888277013209, UDI/DI (CS) 40888277013200; sss) Model Number DYNJ42913A, UDI/DI (EA) 10195327080600, UDI/DI (CS) 40195327080601; ttt) Model Number DYNJ44519F, UDI/DI (EA) 10193489467475, UDI/DI (CS) 40193489467476; uuu) Model Number DYNJ45033A, UDI/DI (EA) 10193489475807, UDI/DI (CS) 40193489475808; vvv) Model Number DYNJ45294, UDI/DI (EA) 10888277098978, UDI/DI (CS) 40888277098979; www) Model Number DYNJ45997C, UDI/DI (EA) 10889942684366, UDI/DI (CS) 40889942684367; xxx) Model Number DYNJ47502B, UDI/DI (EA) 10193489649222, UDI/DI (CS) 40193489649223; yyy) Model Number DYNJ47987B, UDI/DI (EA) 10193489867374, UDI/DI (CS) 40193489867375; zzz) Model Number DYNJ48454, UDI/DI (EA) 10888277595286, UDI/DI (CS) 40888277595287; aaaa) Model Number DYNJ48456B, UDI/DI (EA) 10889942733170, UDI/DI (CS) 40889942733171; bbbb) Model Number DYNJ49177F, UDI/DI (EA) 10888277774346, UDI/DI (CS) 40888277774347; cccc) Model Number DYNJ49737C, UDI/DI (EA) 10195327235888, UDI/DI (CS) 40195327235889; dddd) Model Number DYNJ51248B, UDI/DI (EA) 10889942873401, UDI/DI (CS) 40889942873402; eeee) Model Number DYNJ51340D, UDI/DI (EA) 10193489569810, UDI/DI (CS) 40193489569811; ffff) Model Number DYNJ51638C, UDI/DI (EA) 10195327039561, UDI/DI (CS) 40195327039562; gggg) Model Number DYNJ51705B, UDI/DI (EA) 10193489877175, UDI/DI (CS) 40193489877176; hhhh) Model Number DYNJ52122B, UDI/DI (EA) 10193489935301, UDI/DI (CS) 40193489935302; iiii) Model Number DYNJ52122C, UDI/DI (EA) 10195327260088, UDI/DI (CS) 40195327260089; jjjj) Model Number DYNJ52171, UDI/DI (EA) 10889942243471, UDI/DI (CS) 40889942243472; kkkk) Model Number DYNJ53122B, UDI/DI (EA) 10193489321227, UDI/DI (CS) 40193489321228; llll) Model Number DYNJ53135C, UDI/DI (EA) 10193489468434, UDI/DI (CS) 40193489468435; mmmm) Model Number DYNJ53319C, UDI/DI (EA) 10193489634495, UDI/DI (CS) 40193489634496; nnnn) Model Number DYNJ53435C, UDI/DI (EA) 10193489200867, UDI/DI (CS) 40193489200868; oooo) Model Number DYNJ53482A, UDI/DI (EA) 10889942917310, UDI/DI (CS) 40889942917311; pppp) Model Number DYNJ53658A, UDI/DI (EA) 10889942684403, UDI/DI (CS) 40889942684404; qqqq) Model Number DYNJ54131, UDI/DI (EA) 10889942466801, UDI/DI (CS) 40889942466802; rrrr) Model Number DYNJ54265, UDI/DI (EA) 10889942474004, UDI/DI (CS) 40889942474005; ssss) Model Number DYNJ54437C, UDI/DI (EA) 10193489243970, UDI/DI (CS) 40193489243971; tttt) Model Number DYNJ54569A, UDI/DI (EA) 10193489742954, UDI/DI (CS) 40193489742955; uuuu) Model Number DYNJ54894A, UDI/DI (EA) 10193489213553, UDI/DI (CS) 40193489213554; vvvv) Model Number DYNJ55063A, UDI/DI (EA) 10193489680546, UDI/DI (CS) 40193489680547; wwww) Model Number DYNJ55456, UDI/DI (EA) 10889942548446, UDI/DI (CS) 40889942548447; xxxx) Model Number DYNJ55457, UDI/DI (EA) 10889942548460, UDI/DI (CS) 40889942548461; yyyy) Model Number DYNJ55458, UDI/DI (EA) 10889942548453, UDI/DI (CS) 40889942548454; zzzz) Model Number DYNJ55723A, UDI/DI (EA) 10889942865536, UDI/DI (CS) 40889942865537

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b)…

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)