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 DYNJ64675, UDI/DI (EA) 10193489212143,UDI/DI (CS) 40193489212144; b) Model Number DYNJ64725B, UDI/DI (EA) 10193489452846,UDI/DI (CS) 40193489452847; c) Model Number DYNJ65560C, UDI/DI (EA) 10195327136819,UDI/DI (CS) 40195327136810; d) Model Number DYNJ65775, UDI/DI (EA) 10193489289824,UDI/DI (CS) 40193489289825; e) Model Number DYNJ65827, UDI/DI (EA) 10193489298499,UDI/DI (CS) 40193489298490; f) Model Number DYNJ65838, UDI/DI (EA) 10193489303261,UDI/DI (CS) 40193489303262; g) Model Number DYNJ66062, UDI/DI (EA) 10193489319217,UDI/DI (CS) 40193489319218; h) Model Number DYNJ66259, UDI/DI (EA) 10193489325485,UDI/DI (CS) 40193489325486; i) Model Number DYNJ66271B, UDI/DI (EA) 10193489998917,UDI/DI (CS) 40193489998918; j) Model Number DYNJ66271D, UDI/DI (EA) 10195327130749,UDI/DI (CS) 40195327130740; k) Model Number DYNJ66356F, UDI/DI (EA) 10195327160012,UDI/DI (CS) 40195327160013; l) Model Number DYNJ66499A, UDI/DI (EA) 10193489977523,UDI/DI (CS) 40193489977524; m) Model Number DYNJ66499B, UDI/DI (EA) 10195327242107,UDI/DI (CS) 40195327242108; n) Model Number DYNJ66743B, UDI/DI (EA) 10193489949797,UDI/DI (CS) 40193489949798; o) Model Number DYNJ66916, UDI/DI (EA) 10193489387650,UDI/DI (CS) 40193489387651; p) Model Number DYNJ67115A, UDI/DI (EA) 10195327091880,UDI/DI (CS) 40195327091881; q) Model Number DYNJ67415, UDI/DI (EA) 10193489930887,UDI/DI (CS) 40193489930888; r) Model Number DYNJ67534, UDI/DI (EA) 10193489409321,UDI/DI (CS) 40193489409322; s) Model Number DYNJ67606, UDI/DI (EA) 10193489421675,UDI/DI (CS) 40193489421676; t) Model Number DYNJ69012A, UDI/DI (EA) 10195327331719,UDI/DI (CS) 40195327331710; u) Model Number DYNJ69088, UDI/DI (EA) 10193489883619,UDI/DI (CS) 40193489883610; v) Model Number DYNJ69088A, UDI/DI (EA) 10193489975246,UDI/DI (CS) 40193489975247; w) Model Number DYNJ69091A, UDI/DI (EA) 10193489969764,UDI/DI (CS) 40193489969765; x) Model Number DYNJ69091B, UDI/DI (EA) 10195327178994,UDI/DI (CS) 40195327178995; y) Model Number DYNJ69177, UDI/DI (EA) 10193489902198,UDI/DI (CS) 40193489902199; z) Model Number DYNJ69272, UDI/DI (EA) 10193489920338,UDI/DI (CS) 40193489920339; aa) Model Number DYNJ69288, UDI/DI (EA) 10193489922677,UDI/DI (CS) 40193489922678; bb) Model Number DYNJ69426, UDI/DI (EA) 10193489939392,UDI/DI (CS) 40193489939393; cc) Model Number DYNJ69769, UDI/DI (EA) 10193489977790,UDI/DI (CS) 40193489977791; dd) Model Number DYNJ69796, UDI/DI (EA) 10193489979350,UDI/DI (CS) 40193489979351; ee) Model Number DYNJ69942A, UDI/DI (EA) 10195327284626,UDI/DI (CS) 40195327284627; ff) Model Number DYNJ69943, UDI/DI (EA) 10193489998443,UDI/DI (CS) 40193489998444; gg) Model Number DYNJ69976, UDI/DI (EA) 10195327001308,UDI/DI (CS) 40195327001309; hh) Model Number DYNJ69976A, UDI/DI (EA) 10195327130398,UDI/DI (CS) 40195327130399; ii) Model Number DYNJ80123, UDI/DI (EA) 10195327009182,UDI/DI (CS) 40195327009183; jj) Model Number DYNJ80169, UDI/DI (EA) 10195327013448,UDI/DI (CS) 40195327013449; kk) Model Number DYNJ80169A, UDI/DI (EA) 10195327169749,UDI/DI (CS) 40195327169740; ll) Model Number DYNJ80643, UDI/DI (EA) 10195327055790,UDI/DI (CS) 40195327055791; mm) Model Number DYNJ80692, UDI/DI (EA) 10195327065546,UDI/DI (CS) 40195327065547; nn) Model Number DYNJ80692A, UDI/DI (EA) 10195327340827,UDI/DI (CS) 40195327340828; oo) Model Number DYNJ81120, UDI/DI (EA) 10195327085889,UDI/DI (CS) 40195327085880; pp) Model Number DYNJ81177, UDI/DI (EA) 10195327089610,UDI/DI (CS) 40195327089611; qq) Model Number DYNJ81212A, UDI/DI (EA) 10195327159863,UDI/DI (CS) 40195327159864; rr) Model Number DYNJ81267, UDI/DI (EA) 10195327101442,UDI/DI (CS) 40195327101443; ss) Model Number DYNJ81592, UDI/DI (EA) 10195327123772,UDI/DI (CS) 40195327123773; tt) Model Number DYNJ81669, UDI/DI (EA) 10195327132323,UDI/DI (CS) 40195327132324; uu) Model Number DYNJ81669B, UDI/DI (EA) 10195327253431,UDI/DI (CS) 40195327253432; vv) Model Number DYNJ81725, UDI/DI (EA) 10195327136758,UDI/DI (CS) 40195327136759; ww) Model Number DYNJ81726, UDI/DI (EA) 10195327136772,UDI/DI (CS) 40195327136773; xx) Model Number DYNJ81834, UDI/DI (EA) 10195327147853,UDI/DI (CS) 40195327147854; yy) Model Number DYNJ82033, UDI/DI (EA) 10195327162979,UDI/DI (CS) 40195327162970; zz) Model Number DYNJ82033A, UDI/DI (EA) 10195327271442,UDI/DI (CS) 40195327271443; aaa) Model Number DYNJ82100, UDI/DI (EA) 10195327170592,UDI/DI (CS) 40195327170593; bbb) Model Number DYNJ82101, UDI/DI (EA) 10195327170585,UDI/DI (CS) 40195327170586; ccc) Model Number DYNJ82581, UDI/DI (EA) 10195327198657,UDI/DI (CS) 40195327198658; ddd) Model Number DYNJ82884, UDI/DI (EA) 10195327215996,UDI/DI (CS) 40195327215997; eee) Model Number DYNJ82885, UDI/DI (EA) 10195327216009,UDI/DI (CS) 40195327216000; fff) Model Number DYNJ82951, UDI/DI (EA) 10195327218973,UDI/DI (CS) 40195327218974; ggg) Model Number DYNJ82989, UDI/DI (EA) 10195327221768,UDI/DI (CS) 40195327221769; hhh) Model Number DYNJ83087, UDI/DI (EA) 10195327231255,UDI/DI (CS) 40195327231256; iii) Model Number DYNJ83148, UDI/DI (EA) 10195327235512,UDI/DI (CS) 40195327235513; jjj) Model Number DYNJ83384A, UDI/DI (EA) 10195327304812,UDI/DI (CS) 40195327304813; kkk) Model Number DYNJ83534, UDI/DI (EA) 10195327276713,UDI/DI (CS) 40195327276714; lll) Model Number DYNJ83747, UDI/DI (EA) 10195327300739,UDI/DI (CS) 40195327300730; mmm) Model Number DYNJ83846, UDI/DI (EA) 10195327311490,UDI/DI (CS) 40195327311491; nnn) Model Number DYNJ83914, UDI/DI (EA) 10195327313128,UDI/DI (CS) 40195327313129; ooo) Model Number DYNJ83935, UDI/DI (EA) 10195327318543,UDI/DI (CS) 40195327318544; ppp) Model Number DYNJ83974, UDI/DI (EA) 10195327323141,UDI/DI (CS) 40195327323142; qqq) Model Number DYNJ902602I, UDI/DI (EA) 10193489892567,UDI/DI (CS) 40193489892568; rrr) Model Number DYNJ905285D, UDI/DI (EA) 10195327062668,UDI/DI (CS) 40195327062669; sss) Model Number DYNJ906011B, UDI/DI (EA) 10193489411232,UDI/DI (CS) 40193489411233; ttt) Model Number DYNJ907381, UDI/DI (EA) 10193489900774,UDI/DI (CS) 40193489900775; uuu) Model Number DYNJ907858, UDI/DI (EA) 10193489909357,UDI/DI (CS) 40193489909358; vvv) Model Number DYNJT2272J, UDI/DI (EA) 10889942426324,UDI/DI (CS) 40889942426325; www) Model Number DYNJT2272K, UDI/DI (EA) 10195327250676,UDI/DI (CS) 40195327250677; xxx) Model Number GSS584Q, UDI/DI (EA) 10193489941029,UDI/DI (CS) 40193489941020; yyy) Model Number IVS3635A, UDI/DI (EA) 10193489362916,UDI/DI (CS) 40193489362917; zzz) Model Number MNS13555, UDI/DI (EA) 10653160991953,UDI/DI (CS) 40653160991954; aaaa) Model Number P155508D, UDI/DI (EA) 10193489899061,UDI/DI (CS) 40193489899062; bbbb) Model Number PICC0018, UDI/DI (EA) 10195327327392,UDI/DI (CS) 40195327327393; cccc) Model Number PICCNC0008, UDI/DI (EA) 10195327221584,UDI/DI (CS) 40195327221585; dddd) Model Number PICCNC0013, UDI/DI (EA) 10195327311223,UDI/DI (CS) 40195327311224; eeee) Model Number PICCNC002, UDI/DI (EA) 10193489877199,UDI/DI (CS) 40193489877190; ffff) Model Number VC-PP-6F12, UDI/DI (EA) 10193489576658,UDI/DI (CS) 40193489576659; gggg) Model Number VC-PPH-6F12A, UDI/DI (EA) 10193489423105,UDI/DI (CS) 40193489423106; hhhh) Model Number VC-PPH-6F7A, UDI/DI (EA) 10193489423099,UDI/DI (CS) 40193489423090; iiii) Model Number VC-PPM-12F, UDI/DI (EA) 10193489422689,UDI/DI (CS) 40193489422680;

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) PORT PACK, Model Number DYNJ64675; b) PICC LINE TRAY, 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)