Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGR...
FDA Device Recall #Z-2160-2023 — Class II — May 18, 2023
Recall Summary
| Recall Number | Z-2160-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 18, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 173449 units |
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRAPE PACK, Model Number 00-400305R; b) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936C; c) ANGIO HOLLAND PACK-LF, Model Number DYNJ0037936D; d) ANGIOGRAM, Model Number DYNJ0149444N; e) DIALYSIS CATH INSERTION PK-LF, Model Number DYNJ0198765G; f) PICC LINE PACK-LF, Model Number DYNJ0275614F; g) ANGIOGRAPHY PACK-LF, Model Number DYNJ0290716M; h) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233V; i) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233W; j) ANGIO CATH LAB PACK-LF, Model Number DYNJ0313233X; k) ANGIO PACK-LF, Model Number DYNJ0407399P; l) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535AA; m) VISCERAL ANGIOGRAM PACK-LF, Model Number DYNJ0429121K; n) CARDIAC EP PACK-LF, Model Number DYNJ0429185L; o) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0458661C; p) LT HEART/ANGIOGRAPHY PACK-LF, Model Number DYNJ0537652AG; q) CATH LAB ANGIO PACK-LF, Model Number DYNJ0545064AA; r) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508R; s) CARDIAC CATH PACK-LF, Model Number DYNJ0842644F; t) PEDIATRIC CATH PACK-LF, Model Number DYNJ0843244K; u) ANGIOGRAPHY PACK-LF, Model Number DYNJ0854485V; v) CARDIAC CATH PACK-LF, Model Number DYNJ0855138P; w) CARDIAC CATH PACK-LF, Model Number DYNJ0855138Q; x) IR PICC PACK-LF, Model Number DYNJ0950839C; y) SPECIAL PROCEDURES, Model Number DYNJ23288C; z) ANGIO TRAY, Model Number DYNJ23438M; aa) ADULT CARDIAC CATH PACK, Model Number DYNJ23455K; bb) ADULT CARDIAC CATH PACK, Model Number DYNJ23455L; cc) ADULT CARDIAC CATH PACK, Model Number DYNJ23455M; dd) ADULT CARDIAC CATH PACK, Model Number DYNJ23455N; ee) STENT PACK-LF, Model Number DYNJ27613K; ff) CATH I W/ ANGIO DRAPE, Model Number DYNJ33709F; gg) JUGULAR PACK, Model Number DYNJ35164C; hh) ANGIO DRAPE PACK RADIOLOGY-LF, Model Number DYNJ35993F; ii) ANGIO DRAPE II-LF, Model Number DYNJ35994C; jj) ANGIO/PICC PACK, Model Number DYNJ36049A; kk) ISSAQUA CATH/IR PACK, Model Number DYNJ36738G; ll) IR PACK, Model Number DYNJ36752B; mm) ARTERIOGRAM TRAY-LF, Model Number DYNJ36807C; nn) SPECIAL PROCEDURE PACK, Model Number DYNJ38314G; oo) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326G; pp) CARDIAC CATH PACK, Model Number DYNJ38866F; qq) INTERVENTIONAL RAD L J-LF, Model Number DYNJ40215B; rr) ABLATION PACK, Model Number DYNJ40629C; ss) CATH LAB PACK, Model Number DYNJ40926A; tt) RADIOLOGY PACK, Model Number DYNJ41190; uu) TV IR PACK-LF, Model Number DYNJ41562F; vv) CUSTOM ANGIO TRAY, Model Number DYNJ41649G; ww) CARDIAC CATH DRAPE PACK, Model Number DYNJ41700A; xx) IR PACK, Model Number DYNJ41989G; yy) INTERVENTIONAL RADIOLOGY PACK, Model Number DYNJ42231C; zz) ANGIO PACK, Model Number DYNJ42903C; aaa) ANGIO PACK, Model Number DYNJ42903D; bbb) CARDIAC CATH PACK-LF, Model Number DYNJ42996C; ccc) DIALYSIS TRAY, Model Number DYNJ43060B; ddd) ANGIOPLASTY PACK-LF, Model Number DYNJ43203G; eee) ARTERIOGRAM PACK, Model Number DYNJ43261J; fff) CATH LAB RIGHT HEART PACK, Model Number DYNJ43315L; ggg) ANGIO CATH COMBINED PACK, Model Number DYNJ43609P; hhh) ANGIO CATH COMBINED PACK, Model Number DYNJ43609R; iii) ANGIO CATH COMBINED PACK, Model Number DYNJ43609S; jjj) ANGIO PACK, Model Number DYNJ43661C; kkk) ABLATION EP PACK, Model Number DYNJ43851B; lll) PK, RADIOLOGY, Model Number DYNJ43894B; mmm) PK, RADIOLOGY, Model Number DYNJ44087A; nnn) ANGIOGRAPHY PACK, Model Number DYNJ44293F; ooo) ANGIO DRAPE PACK, Model Number DYNJ44320G; ppp) ANGIO DRAPE PACK, Model Number DYNJ44320I; qqq) ANGIO DRAPE PACK, Model Number DYNJ44320J; rrr) FEMORAL ANGIO PACK, Model Number DYNJ44334M; sss) FEMORAL ANGIO PACK, Model Number DYNJ44334N; ttt) RADIOLOGY PACK, Model Number DYNJ44524F; uuu) ANGIO PACK, Model Number DYNJ44642B; vvv) ANGIOPLASTY PACK, Model Number DYNJ44700J; www) ANGIO PACK, Model Number DYNJ44993J; xxx) ANGIOGRAPHY PACK, Model Number DYNJ45059B; yyy) PERCUTANEOUS PACK, Model Number D
Reason for Recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Lot / Code Information
all lots within expiry, distributed from Medline between December 2017- May 2023: a) Model Number 00-400305R, UDI/DI (EA) 10193489944280, UDI/DI (CS) 40193489944281; b) Model Number DYNJ0037936C, UDI/DI (EA) 10195327031282, UDI/DI (CS) 40195327031283; c) Model Number DYNJ0037936D, UDI/DI (EA) 10195327129538, UDI/DI (CS) 40195327129539; d) Model Number DYNJ0149444N, UDI/DI (EA) 10193489966718, UDI/DI (CS) 40193489966719; e) Model Number DYNJ0198765G, UDI/DI (EA) 10889942053988, UDI/DI (CS) 40889942053989; f) Model Number DYNJ0275614F, UDI/DI (EA) 10889942174348, UDI/DI (CS) 40889942174349; g) Model Number DYNJ0290716M, UDI/DI (EA) 10195327088866, UDI/DI (CS) 40195327088867; h) Model Number DYNJ0313233V, UDI/DI (EA) 10889942247356, UDI/DI (CS) 40889942247357; i) Model Number DYNJ0313233W, UDI/DI (EA) 10195327110970, UDI/DI (CS) 40195327110971; j) Model Number DYNJ0313233X, UDI/DI (EA) 10195327250980, UDI/DI (CS) 40195327250981; k) Model Number DYNJ0407399P, UDI/DI (EA) 10195327336868, UDI/DI (CS) 40195327336869; l) Model Number DYNJ0416535AA, UDI/DI (EA) 10195327354596, UDI/DI (CS) 40195327354597; m) Model Number DYNJ0429121K, UDI/DI (EA) 10195327069506, UDI/DI (CS) 40195327069507; n) Model Number DYNJ0429185L, UDI/DI (EA) 10195327048976, UDI/DI (CS) 40195327048977; o) Model Number DYNJ0458661C, UDI/DI (EA) 10889942550944, UDI/DI (CS) 40889942550945; p) Model Number DYNJ0537652AG, UDI/DI (EA) 10195327017675, UDI/DI (CS) 40195327017676; q) Model Number DYNJ0545064AA, UDI/DI (EA) 10195327327385, UDI/DI (CS) 40195327327386; r) Model Number DYNJ0604508R, UDI/DI (EA) 10193489828443, UDI/DI (CS) 40193489828444; s) Model Number DYNJ0842644F, UDI/DI (EA) 10195327288600, UDI/DI (CS) 40195327288601; t) Model Number DYNJ0843244K, UDI/DI (EA) 10195327288594, UDI/DI (CS) 40195327288595; u) Model Number DYNJ0854485V, UDI/DI (EA) 10195327096885, UDI/DI (CS) 40195327096886; v) Model Number DYNJ0855138P, UDI/DI (EA) 10193489885132, UDI/DI (CS) 40193489885133; w) Model Number DYNJ0855138Q, UDI/DI (EA) 10195327094843, UDI/DI (CS) 40195327094844; x) Model Number DYNJ0950839C, UDI/DI (EA) 10889942101290, UDI/DI (CS) 40889942101291; y) Model Number DYNJ23288C, UDI/DI (EA) 10193489954142, UDI/DI (CS) 40193489954143; z) Model Number DYNJ23438M, UDI/DI (EA) 10193489970609, UDI/DI (CS) 40193489970600; aa) Model Number DYNJ23455K, UDI/DI (EA) 10193489446296, UDI/DI (CS) 40193489446297; bb) Model Number DYNJ23455L, UDI/DI (EA) 10193489977387, UDI/DI (CS) 40193489977388; cc) Model Number DYNJ23455M, UDI/DI (EA) 10195327129835, UDI/DI (CS) 40195327129836; dd) Model Number DYNJ23455N, UDI/DI (EA) 10195327237752, UDI/DI (CS) 40195327237753; ee) Model Number DYNJ27613K, UDI/DI (EA) 10195327131180, UDI/DI (CS) 40195327131181; ff) Model Number DYNJ33709F, UDI/DI (EA) 10889942713929, UDI/DI (CS) 40889942713920; gg) Model Number DYNJ35164C, UDI/DI (EA) 10889942494668, UDI/DI (CS) 40889942494669; hh) Model Number DYNJ35993F, UDI/DI (EA) 10195327398286, UDI/DI (CS) 40195327398287; ii) Model Number DYNJ35994C, UDI/DI (EA) 10195327397951, UDI/DI (CS) 40195327397952; jj) Model Number DYNJ36049A, UDI/DI (EA) 10195327147204, UDI/DI (CS) 40195327147205; kk) Model Number DYNJ36738G, UDI/DI (EA) 10195327054168, UDI/DI (CS) 40195327054169; ll) Model Number DYNJ36752B, UDI/DI (EA) 10195327226022, UDI/DI (CS) 40195327226023; mm) Model Number DYNJ36807C, UDI/DI (EA) 10195327082222, UDI/DI (CS) 40195327082223; nn) Model Number DYNJ38314G, UDI/DI (EA) 10193489603347, UDI/DI (CS) 40193489603348; oo) Model Number DYNJ38326G, UDI/DI (EA) 10195327230135, UDI/DI (CS) 40195327230136; pp) Model Number DYNJ38866F, UDI/DI (EA) 10193489914863, UDI/DI (CS) 40193489914864; qq) Model Number DYNJ40215B, UDI/DI (EA) 10888277912267, UDI/DI (CS) 40888277912268; rr) Model Number DYNJ40629C, UDI/DI (EA) 10193489997316, UDI/DI (CS) 40193489997317; ss) Model Number DYNJ40926A, UDI/DI (EA) 10195327137212, UDI/DI (CS) 40195327137213; tt) Model Number DYNJ41190, UDI/DI (EA) 10884389899083, UDI/DI (CS) 40884389899084; uu) Model Number DYNJ41562F, UDI/DI (EA) 10193489641080, UDI/DI (CS) 40193489641081; vv) Model Number DYNJ41649G, UDI/DI (EA) 10195327277291, UDI/DI (CS) 40195327277292; ww) Model Number DYNJ41700A, UDI/DI (EA) 10889942756957, UDI/DI (CS) 40889942756958; xx) Model Number DYNJ41989G, UDI/DI (EA) 10193489310801, UDI/DI (CS) 40193489310802; yy) Model Number DYNJ42231C, UDI/DI (EA) 10195327026561, UDI/DI (CS) 40195327026562; zz) Model Number DYNJ42903C, UDI/DI (EA) 10195327079666, UDI/DI (CS) 40195327079667; aaa) Model Number DYNJ42903D, UDI/DI (EA) 10195327171117, UDI/DI (CS) 40195327171118; bbb) Model Number DYNJ42996C, UDI/DI (EA) 10193489988437, UDI/DI (CS) 40193489988438; ccc) Model Number DYNJ43060B, UDI/DI (EA) 10889942765850, UDI/DI (CS) 40889942765851; ddd) Model Number DYNJ43203G, UDI/DI (EA) 10193489952919, UDI/DI (CS) 40193489952910; eee) Model Number DYNJ43261J, UDI/DI (EA) 10195327288792, UDI/DI (CS) 40195327288793; fff) Model Number DYNJ43315L, UDI/DI (EA) 10193489463675, UDI/DI (CS) 40193489463676; ggg) Model Number DYNJ43609P, UDI/DI (EA) 10193489914535, UDI/DI (CS) 40193489914536; hhh) Model Number DYNJ43609R, UDI/DI (EA) 10195327228781, UDI/DI (CS) 40195327228782; iii) Model Number DYNJ43609S, UDI/DI (EA) 10195327322984, UDI/DI (CS) 40195327322985; jjj) Model Number DYNJ43661C, UDI/DI (EA) 10195327104351, UDI/DI (CS) 40195327104352; kkk) Model Number DYNJ43851B, UDI/DI (EA) 10195327200329, UDI/DI (CS) 40195327200320; lll) Model Number DYNJ43894B, UDI/DI (EA) 10193489810486, UDI/DI (CS) 40193489810487; mmm) Model Number DYNJ44087A, UDI/DI (EA) 10889942561803, UDI/DI (CS) 40889942561804; nnn) Model Number DYNJ44293F, UDI/DI (EA) 10195327265182, UDI/DI (CS) 40195327265183; ooo) Model Number DYNJ44320G, UDI/DI (EA) 10193489966305, UDI/DI (CS) 40193489966306; ppp) Model Number DYNJ44320I, UDI/DI (EA) 10195327070359, UDI/DI (CS) 40195327070350; qqq) Model Number DYNJ44320J, UDI/DI (EA) 10195327132354, UDI/DI (CS) 40195327132355; rrr) Model Number DYNJ44334M, UDI/DI (EA) 10195327133115, UDI/DI (CS) 40195327133116; sss) Model Number DYNJ44334N, UDI/DI (EA) 10195327299491, UDI/DI (CS) 40195327299492; ttt) Model Number DYNJ44524F, UDI/DI (EA) 10193489467482, UDI/DI (CS) 40193489467483; uuu) Model Number DYNJ44642B, UDI/DI (EA) 10195327011420, UDI/DI (CS) 40195327011421; vvv) Model Number DYNJ44700J, UDI/DI (EA) 10195327277413, UDI/DI (CS) 40195327277414; www) Model Number DYNJ44993J, UDI/DI (EA) 10195327380922, UDI/DI (CS) 40195327380923; xxx) Model Number DYNJ45059B, UDI/DI (EA) 10889942135639, UDI/DI (CS) 40889942135630; yyy) Model Number DYNJ46035D, UDI/DI (EA) 10193489493641, UDI/DI (CS) 40193489493642; zzz) Model Number DYNJ46545B, UDI/DI (EA) 10195327008246, UDI/DI (CS) 40195327008247; aaaa) Model Number DYNJ46545C, UDI/DI (EA) 10195327250423, UDI/DI (CS) 40195327250424; bbbb) Model Number DYNJ47645B, UDI/DI (EA) 10193489952834, UDI/DI (CS) 40193489952835; cccc) Model Number DYNJ47646D, UDI/DI (EA) 10193489950472, UDI/DI (CS) 40193489950473; dddd) Model Number DYNJ47646F, UDI/DI (EA) 10195327155513, UDI/DI (CS) 40195327155514; eeee) Model Number DYNJ47646G, UDI/DI (EA) 10195327175023, UDI/DI (CS) 40195327175024; ffff) Model Number DYNJ47646I, UDI/DI (EA) 10195327357122, UDI/DI (CS) 40195327357123; gggg) Model Number DYNJ47665D, UDI/DI (EA) 10193489952827, UDI/DI (CS) 40193489952828; hhhh) Model Number DYNJ47665F, UDI/DI (EA) 10195327355210, UDI/DI (CS) 40195327355211; iiii) Model Number DYNJ49621C, UDI/DI (EA) 10195327008581, UDI/DI (CS) 40195327008582; jjjj) Model Number DYNJ50694A, UDI/DI (EA) 10889942693511, UDI/DI (CS) 40889942693512; kkkk) Model Number DYNJ50712D, UDI/DI (EA) 10195327267926, UDI/DI (CS) 40195327267927; llll) Model Number DYNJ51109B, UDI/DI (EA) 10889942456314, UDI/DI (CS) 40889942456315; mmmm) Model Number DYNJ51240A, UDI/DI (EA) 10889942493524, UDI/DI (CS) 40889942493525; nnnn) Model Number DYNJ51338C, UDI/DI (EA) 10193489241716, UDI/DI (CS) 40193489241717; oooo) Model Number DYNJ52000B, UDI/DI (EA) 10193489384987, UDI/DI (CS) 40193489384988; pppp) Model Number DYNJ52121A, UDI/DI (EA) 10195327260095, UDI/DI (CS) 40195327260096; qqqq) Model Number DYNJ52425J, UDI/DI (EA) 10193489940145, UDI/DI (CS) 40193489940146; rrrr) Model Number DYNJ52425K, UDI/DI (EA) 10195327042356, UDI/DI (CS) 40195327042357; ssss) Model Number DYNJ52425L, UDI/DI (EA) 10195327074487, UDI/DI (CS) 40195327074488; tttt) Model Number DYNJ52425M, UDI/DI (EA) 10195327177188, UDI/DI (CS) 40195327177189; uuuu) Model Number DYNJ52425N, UDI/DI (EA) 10195327339326, UDI/DI (CS) 40195327339327; vvvv) Model Number DYNJ52774, UDI/DI (EA) 10889942322473, UDI/DI (CS) 40889942322474; wwww) Model Number DYNJ52806C, UDI/DI (EA) 10193489292909, UDI/DI (CS) 40193489292900; xxxx) Model Number DYNJ53095, UDI/DI (EA) 10889942371778, UDI/DI (CS) 40889942371779; yyyy) Model Number DYNJ53481D, UDI/DI (EA) 10193489812572, UDI/DI (CS) 40193489812573; zzzz) Model Number DYNJ54755I, UDI/DI (EA) 10195327021269, UDI/DI (CS) 40195327021260
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.