--- title: "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the fo... — FDA record Z-2163-2023 | Is It on Recall" description: "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams." url: https://isitonrecall.com/recall/fda-device-z-2163-2023-medline-probe-cover-kits-containing-sterile-ultrasound-gel-labeled-as-the-following-a-norton-childre/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF... — FDA record Z-2163-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date May 18, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-401185Q; b. PERCUTANEOUS VASCULAR CDS, Model Number CDS840487I; c. BAPTIST SOUTH OPEN HEART CV PK, Model Number CDS983147I; d. ENDOVASCULAR CDS, Model Number CDS983394I; e. ENDOVASCULAR CDS, Model Number CDS983394J; f. ENDOVASCULAR CDS, Model Number CDS983394K; g. OPEN HEART CDS, Model Number CDS983513F; h. OPEN HEART ANESTHESIA PACK, Model Number CDS983849D; i. OPEN HEART ANESTHESIA PACK, Model Number CDS983849F; j. VNUS, Model Number CDS984292I; k. OPEN HEART CDS, Model Number CDS984355G; l. BEDSIDE PICC CDS, Model Number CDS984642; m. VASCULAR, Model Number CDS984764G; n. OPEN HEART A, Model Number CDS985105O; o. VASCULAR, Model Number CDS985355D; p. VASCULAR, Model Number CDS985355F; q. ECMO KIT, Model Number CVI4955; r. KIT CARDIAC CSICU ADULT ECMO, Model Number DYKMBNDL21; s. VASCULAR ACCESS PROCEDURE KIT, Model Number DYNDA2526; t. ARTERIAL/VENOUS ACCESS TRAY, Model Number DYNDC3038; u. DIAGNOSTIC RADIO HOLLAN PK-LF, Model Number DYNJ0037939B; v. OPEN HEART CABG PACK-LF, Model Number DYNJ0149567C; w. VASCULAR ANGIO PACK-LF, Model Number DYNJ0201109AJ; x. OPEN HEART PACK-LF, Model Number DYNJ0371669N; y. CABG PACK, Model Number DYNJ0408782AA; z. CARDIAC EP PACK-LF, Model Number DYNJ0429185K; aa. CARDIAC EP PACK-LF, Model Number DYNJ0429185M; bb. OPEN HEART A & B PACK, Model Number DYNJ0450131AI; cc. VASCULAR PACK-LF, Model Number DYNJ0493141J; dd. RIGHT HEART PACK-LF, Model Number DYNJ0565558U; ee. ENDO VASCULAR PACK-LF, Model Number DYNJ0676055N; ff. LOWER ENDO VASCULAR PACK, Model Number DYNJ0678934G; gg. ENDOVASCULAR PACK, Model Number DYNJ0678934I; hh. RR-NEURO DBS HEAD PACK-LF, Model Number DYNJ0785736J; ii. ELECTROPHYSIOLOGY PACK-LF, Model Number DYNJ0842825D; jj. VASCULAR PACK-LF, Model Number DYNJ0871182AC; kk. ELECTROPHYSIOLOGY TRAY-LF, Model Number DYNJ09878D; ll. EP PACK, Model Number DYNJ16618J; mm. EP PACK, Model Number DYNJ16618K; nn. ST MARY'S STL OPEN HRT SUPPLY, Model Number DYNJ20031C; oo. VEIN PACK, Model Number DYNJ21949J; pp. VASCULAR PACK, Model Number DYNJ22350L; qq. EP PACK, Model Number DYNJ23456K; rr. ANGIO-VASCULAR, Model Number DYNJ24272C; ss. EP ANGIO PACK, Model Number DYNJ25749S; tt. C.V. MINOR PACK, Model Number DYNJ28849B; uu. EP TRAY, Model Number DYNJ31928D; vv. PACER PACK, Model Number DYNJ34844C; ww. ADULT CARDIO TRAY, Model Number DYNJ35495G; xx. PEDIATRIC CARDIO CATH PACK, Model Number DYNJ35578G; yy. CARDIO B PACK, Model Number DYNJ36052O; zz. VASCULAR ENDO LASER PK, Model Number DYNJ37445I; aaa. VEIN PROCEDURE PACK, Model Number DYNJ38264D; bbb. HMT VEIN PACK, Model Number DYNJ38756B; ccc. LASER AND VEIN PACK, Model Number DYNJ38995C; ddd. VEIN CLOSURE PACK, Model Number DYNJ39408F; eee. CAROTID PACK, Model Number DYNJ39488G; fff. VEIN PACK, Model Number DYNJ39889; ggg. CVL CUSTOM PACK, Model Number DYNJ40067G; hhh. AV GRAFT-LF, Model Number DYNJ40077F; iii. VASCUL... - **Reason**: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. - **Classification**: Class II - **Recalling firm**: MEDLINE INDUSTRIES, LP - Northfield - **Quantity**: 172722 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2163-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2163-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | all lots within expiry, distributed from Medline between December 2017 May 2023: a) Model Number 00-401185Q, UDI/DI (EA) 10193489489088, UDI/DI (CS)40193489489089; b) Model Number CDS840487I, UDI/DI (EA) 10193489445343, UDI/DI (CS)40193489445344; c) Model Number CDS983147I, UDI/DI (EA) 10195327075514, UDI/DI (CS)40195327075515; d) Model Number CDS983394I, UDI/DI (EA) 10193489819953, UDI/DI (CS)40193489819954; e) Model Number CDS983394J, UDI/DI (EA) 10195327069872, UDI/DI (CS)40195327069873; f) Model Number CDS983394K, UDI/DI (EA) 10195327292584, UDI/DI (CS)40195327292585; g) Model Number CDS983513F, UDI/DI (EA) 10193489843729, UDI/DI (CS)40193489843720; h) Model Number CDS983849D, UDI/DI (EA) 10193489278231, UDI/DI (CS)40193489278232; i) Model Number CDS983849F, UDI/DI (EA) 10195327228316, UDI/DI (CS)40195327228317; j) Model Number CDS984292I, UDI/DI (EA) 10193489862485, UDI/DI (CS)40193489862486; k) Model Number CDS984355G, UDI/DI (EA) 10193489484632, UDI/DI (CS)40193489484633; l) Model Number CDS984642, UDI/DI (EA) 10884389882924, UDI/DI (CS)40884389882925; m) Model Number CDS984764G, UDI/DI (EA) 10193489450293, UDI/DI (CS)40193489450294; n) Model Number CDS985105O, UDI/DI (EA) 10195327036249, UDI/DI (CS)40195327036240; o) Model Number CDS985355D, UDI/DI (EA) 10193489442779, UDI/DI (CS)40193489442770; p) Model Number CDS985355F, UDI/DI (EA) 10195327242626, UDI/DI (CS)40195327242627; q) Model Number CVI4955, UDI/DI (EA) 10195327325848, UDI/DI (CS)40195327325849; r) Model Number DYKMBNDL21, UDI/DI (EA) 10193489478693, UDI/DI (CS)40193489478694; s) Model Number DYNDA2526, UDI/DI (EA) 10193489191790, UDI/DI (CS)40193489191791; t) Model Number DYNDC3038, UDI/DI (EA) 10193489493603, UDI/DI (CS)40193489493604; u) Model Number DYNJ0037939B, UDI/DI (EA) 10195327031275, UDI/DI (CS)40195327031276; v) Model Number DYNJ0149567C, UDI/DI (EA) 10195327235529, UDI/DI (CS)40195327235520; w) Model Number DYNJ0201109AJ, UDI/DI (EA) 10195327325459, UDI/DI (CS)40195327325450; x) Model Number DYNJ0371669N, UDI/DI (EA) 10193489230390, UDI/DI (CS)40193489230391; y) Model Number DYNJ0408782AA, UDI/DI (EA) 10195327115814, UDI/DI (CS)40195327115815; z) Model Number DYNJ0429185K, UDI/DI (EA) 10193489728132, UDI/DI (CS)40193489728133; aa) Model Number DYNJ0429185M, UDI/DI (EA) 10195327371357, UDI/DI (CS)40195327371358; bb) Model Number DYNJ0450131AI, UDI/DI (EA) 10193489466126, UDI/DI (CS)40193489466127; cc) Model Number DYNJ0493141J, UDI/DI (EA) 10193489926224, UDI/DI (CS)40193489926225; dd) Model Number DYNJ0565558U, UDI/DI (EA) 10193489827033, UDI/DI (CS)40193489827034; ee) Model Number DYNJ0676055N, UDI/DI (EA) 10193489954364, UDI/DI (CS)40193489954365; ff) Model Number DYNJ0678934G, UDI/DI (EA) 10193489925265, UDI/DI (CS)40193489925266; gg) Model Number DYNJ0678934I, UDI/DI (EA) 10193489997866, UDI/DI (CS)40193489997867; hh) Model Number DYNJ0785736J, UDI/DI (EA) 10193489202663, UDI/DI (CS)40193489202664; ii) Model Number DYNJ0842825D, UDI/DI (EA) 10195327288617, UDI/DI (CS)40195327288618; jj) Model Number DYNJ0871182AC, UDI/DI (EA) 10195327330859, UDI/DI (CS)40195327330850; kk) Model Number DYNJ09878D, UDI/DI (EA) 10195327387662, UDI/DI (CS)40195327387663; ll) Model Number DYNJ16618J, UDI/DI (EA) 10195327249854, UDI/DI (CS)40195327249855; mm) Model Number DYNJ16618K, UDI/DI (EA) 10195327325572, UDI/DI (CS)40195327325573; nn) Model Number DYNJ20031C, UDI/DI (EA) 10884389650073, UDI/DI (CS)40884389650074; oo) Model Number DYNJ21949J, UDI/DI (EA) 10889942128419, UDI/DI (CS)40889942128410; pp) Model Number DYNJ22350L, UDI/DI (EA) 10193489445251, UDI/DI (CS)40193489445252; qq) Model Number DYNJ23456K, UDI/DI (EA) 10193489967760, UDI/DI (CS)40193489967761; rr) Model Number DYNJ24272C, UDI/DI (EA) 10193489620221, UDI/DI (CS)40193489620222; ss) Model Number DYNJ25749S, UDI/DI (EA) 10195327059705, UDI/DI (CS)40195327059706; tt) Model Number DYNJ28849B, UDI/DI (EA) 10195327319557, UDI/DI (CS)40195327319558; uu) Model Number DYNJ31928D, UDI/DI (EA) 10195327335281, UDI/DI (CS)40195327335282; vv) Model Number DYNJ34844C, UDI/DI (EA) 10193489778076, UDI/DI (CS)40193489778077; ww) Model Number DYNJ35495G, UDI/DI (EA) 10193489803990, UDI/DI (CS)40193489803991; xx) Model Number DYNJ35578G, UDI/DI (EA) 10193489808605, UDI/DI (CS)40193489808606; yy) Model Number DYNJ36052O, UDI/DI (EA) 10195327249533, UDI/DI (CS)40195327249534; zz) Model Number DYNJ37445I, UDI/DI (EA) 10193489417395, UDI/DI (CS)40193489417396; aaa) Model Number DYNJ38264D, UDI/DI (EA) 10193489438499, UDI/DI (CS)40193489438490; bbb) Model Number DYNJ38756B, UDI/DI (EA) 10889942455799, UDI/DI (CS)40889942455790; ccc) Model Number DYNJ38995C, UDI/DI (EA) 10193489713145, UDI/DI (CS)40193489713146; ddd) Model Number DYNJ39408F, UDI/DI (EA) 10193489692839, UDI/DI (CS)40193489692830; eee) Model Number DYNJ39488G, UDI/DI (EA) 10193489383775, UDI/DI (CS)40193489383776; fff) Model Number DYNJ39889, UDI/DI (EA) 10884389796931, UDI/DI (CS)40884389796932; ggg) Model Number DYNJ40067G, UDI/DI (EA) 10195327244033, UDI/DI (CS)40195327244034; hhh) Model Number DYNJ40077F, UDI/DI (EA) 10195327175818, UDI/DI (CS)40195327175819; iii) Model Number DYNJ40108I, UDI/DI (EA) 10195327284183, UDI/DI (CS)40195327284184; jjj) Model Number DYNJ40215C, UDI/DI (EA) 10195327176501, UDI/DI (CS)40195327176502; kkk) Model Number DYNJ40379D, UDI/DI (EA) 10193489257618, UDI/DI (CS)40193489257619; lll) Model Number DYNJ41100C, UDI/DI (EA) 10193489899825, UDI/DI (CS)40193489899826; mmm) Model Number DYNJ41195D, UDI/DI (EA) 10193489314250, UDI/DI (CS)40193489314251; nnn) Model Number DYNJ42976, UDI/DI (EA) 10888277019140, UDI/DI (CS)40888277019141; ooo) Model Number DYNJ43085A, UDI/DI (EA) 10193489600346, UDI/DI (CS)40193489600347; ppp) Model Number DYNJ43922, UDI/DI (EA) 10888277074668, UDI/DI (CS)40888277074669; qqq) Model Number DYNJ44087B, UDI/DI (EA) 10195327346584, UDI/DI (CS)40195327346585; rrr) Model Number DYNJ44345F, UDI/DI (EA) 10889942966523, UDI/DI (CS)40889942966524; sss) Model Number DYNJ44345G, UDI/DI (EA) 10193489939507, UDI/DI (CS)40193489939508; ttt) Model Number DYNJ44421D, UDI/DI (EA) 10193489482638, UDI/DI (CS)40193489482639; uuu) Model Number DYNJ44737B, UDI/DI (EA) 10193489351712, UDI/DI (CS)40193489351713; vvv) Model Number DYNJ44808G, UDI/DI (EA) 10193489875850, UDI/DI (CS)40193489875851; www) Model Number DYNJ45074C, UDI/DI (EA) 10193489222678, UDI/DI (CS)40193489222679; xxx) Model Number DYNJ46246A, UDI/DI (EA) 10889942584963, UDI/DI (CS)40889942584964; yyy) Model Number DYNJ46359D, UDI/DI (EA) 10193489961379, UDI/DI (CS)40193489961370; zzz) Model Number DYNJ47138B, UDI/DI (EA) 10889942274215, UDI/DI (CS)40889942274216; aaaa) Model Number DYNJ47645C, UDI/DI (EA) 10195327355173, UDI/DI (CS)40195327355174; bbbb) Model Number DYNJ47660K, UDI/DI (EA) 10193489875737, UDI/DI (CS)40193489875738; cccc) Model Number DYNJ48365, UDI/DI (EA) 10888277594593, UDI/DI (CS)40888277594594; dddd) Model Number DYNJ48456C, UDI/DI (EA) 10195327015862, UDI/DI (CS)40195327015863; eeee) Model Number DYNJ48907F, UDI/DI (EA) 10889942529421, UDI/DI (CS)40889942529422; ffff) Model Number DYNJ49874, UDI/DI (EA) 10888277890602, UDI/DI (CS)40888277890603; gggg) Model Number DYNJ49931I, UDI/DI (EA) 10193489939217, UDI/DI (CS)40193489939218; hhhh) Model Number DYNJ49933I, UDI/DI (EA) 10193489471687, UDI/DI (CS)40193489471688; iiii) Model Number DYNJ49933J, UDI/DI (EA) 10195327065614, UDI/DI (CS)40195327065615; jjjj) Model Number DYNJ50227C, UDI/DI (EA) 10889942938612, UDI/DI (CS)40889942938613; kkkk) Model Number DYNJ50785, UDI/DI (EA) 10889942105304, UDI/DI (CS)40889942105305; llll) Model Number DYNJ51304C, UDI/DI (EA) 10193489460988, UDI/DI (CS)40193489460989; mmmm) Model Number DYNJ51925F, UDI/DI (EA) 10195327153397, UDI/DI (CS)40195327153398; nnnn) Model Number DYNJ52024, UDI/DI (EA) 10889942233359, UDI/DI (CS)40889942233350; oooo) Model Number DYNJ52056C, UDI/DI (EA) 10193489369441, UDI/DI (CS)40193489369442; pppp) Model Number DYNJ52056D, UDI/DI (EA) 10195327096137, UDI/DI (CS)40195327096138; qqqq) Model Number DYNJ52098, UDI/DI (EA) 10889942237067, UDI/DI (CS)40889942237068; rrrr) Model Number DYNJ52586A, UDI/DI (EA) 10193489494396, UDI/DI (CS)40193489494397; ssss) Model Number DYNJ52586B, UDI/DI (EA) 10195327212117, UDI/DI (CS)40195327212118; tttt) Model Number DYNJ52606F, UDI/DI (EA) 10193489343298, UDI/DI (CS)40193489343299; uuuu) Model Number DYNJ52756A, UDI/DI (EA) 10193489413830, UDI/DI (CS)40193489413831; vvvv) Model Number DYNJ52766A, UDI/DI (EA) 10193489292367, UDI/DI (CS)40193489292368; wwww) Model Number DYNJ53433F, UDI/DI (EA) 10193489328677, UDI/DI (CS)40193489328678; xxxx) Model Number DYNJ53433G, UDI/DI (EA) 10195327042431, UDI/DI (CS)40195327042432; yyyy) Model Number DYNJ53433I, UDI/DI (EA) 10195327074494, UDI/DI (CS)40195327074495; zzzz) Model Number DYNJ53433J, UDI/DI (EA) 10195327222925, UDI/DI (CS)40195327222926; | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia. States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2163-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [MEDLINE INDUSTRIES, LP - Northfield records](https://isitonrecall.com/brand/medline-industries-lp-northfield/)