Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CAT...
FDA Device Recall #Z-2179-2023 — Class II — May 18, 2023
Recall Summary
| Recall Number | Z-2179-2023 |
| 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 | # included in 3,740,814 units total |
Product Description
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NO-CATH RADIAL ARTERIAL PREMIU, Model Number ARTNC115; b) MAJOR VASCULAR, Model Number CDS980752I; c) PICC LINE DOUBLE LUMEN CDS, Model Number CDS982858F; d) PICC LINE TRIPLE LUMEN CDS, Model Number CDS982859F; e) CHP TRANSPLANT CDS, Model Number CDS983082J; f) CLOSURE CDS, Model Number CDS983704I; g) MIDLINE INSERTION TRAY, Model Number CVI4340; h) PORT INSERTION PACK, Model Number CVI4765; i) MAX BARRIER KIT, Model Number DYND2673B; j) POWERGLIDE PLACEMENT KIT, Model Number DYNDA1468C; k) DEPIPPO PACK, Model Number DYNDA2011B; l) VEIN PROCEDURE KIT, Model Number DYNDA2076; m) SCLEROTHERAPY KIT, Model Number DYNDA2148A; n) IR SONO PACK, Model Number DYNDA2365B; o) ULTRASOUND BASIC KIT, Model Number DYNDC2099; p) PIV WITH ULTRASOUND KIT, Model Number DYNDC2399A; q) PARA THORACENTESIS TRAY, Model Number DYNDH1165A; r) ULTRASOUND TRAY, Model Number DYNDH1204; s) PARA/THORACENTESIS TRAY, Model Number DYNDH1292; t) ULTRASOUND GUIDE BREAST BIOPSY, Model Number DYNDH1319; u) PARA/THORACENTESIS TRAY, Model Number DYNDH1470B; v) PARA/THORACENTESIS TRAY, Model Number DYNDH1470C; w) US GUIDED LOC KIT, Model Number DYNDH1492; x) AMINO KIT, Model Number DYNDH1649; y) BREAST ULTRASOUND PROCEDURE TR, Model Number DYNDL1596A; z) ULTRASOUND GUIDED PIV KIT, Model Number DYNDV2038B; aa) ULTRASOUND GUIDED IV/MIDLINE K, Model Number DYNDV2385A; bb) CVL PACK, Model Number DYNJ00281N; cc) FEM POP PACK, Model Number DYNJ01964M; dd) MAXIMUM BARRIER PACK-LF, Model Number DYNJ0248546D; ee) VEIN PACK, Model Number DYNJ0309084D; ff) DR. BAHDOUCH PACK, Model Number DYNJ0351069; gg) ANGIO STANDARD PACK-LF, Model Number DYNJ0370436Q; hh) SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0416535Y; ii) JUDKINS PACK-LF, Model Number DYNJ0530948AR; jj) JUDKINS PACK-LF, Model Number DYNJ0586030P; kk) SPECIAL PROCEDURE PK-LF, Model Number DYNJ0604508Q; ll) MINI PACK-LF, Model Number DYNJ0604540P; mm) MINI PACK-LF, Model Number DYNJ0604540Q; nn) BIOPSY PACK-LF, Model Number DYNJ0747885F; oo) PERC PACK-LF, Model Number DYNJ0774759O; pp) PERC PACK-LF, Model Number DYNJ0774759P; qq) RR-SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0785821N; rr) RR-SPECIAL PROCEDURE PACK-LF, Model Number DYNJ0785821O; ss) CLOSURE PACK-LF, Model Number DYNJ0807503M; tt) LINE PLACEMENT PACK-LF, Model Number DYNJ0931376F; uu) DENTAL PACK-LF, Model Number DYNJ0952428; vv) VENOUS ACCESS TRAY, Model Number DYNJ20094K; ww) DEPAUL IR DIALYSIS PACK, Model Number DYNJ31934D; xx) VEIN CLOSURE PACK, Model Number DYNJ32397B; yy) LARGE PROCEDURE PACK, Model Number DYNJ35524D; zz) RAD CVC TRAY, Model Number DYNJ35574A; aaa) WILDCAT BUNDLE KIT-ADULT, Model Number DYNJ35988J; bbb) WILDCAT BUNDLE KIT-PEDIATRIC, Model Number DYNJ35989G; ccc) STERILE PICC TRAY-LF, Model Number DYNJ36814B; ddd) PARA/THORA PACK, Model Number DYNJ37280C; eee) BASIC PACK, Model Number DYNJ37460A; fff) MINOR SPECIAL PROCEDURE PACK, Model Number DYNJ38326F; ggg) MINOR PROCEDURE PACK, Model Number DYNJ38563O; hhh) VEIN PACK, Model Number DYNJ38682C; iii) ADULT CVC MAX BARRIER KIT-LF, Model Number DYNJ38714B; jjj) PICC LINE INSERTION, Model Number DYNJ39885A; kkk) PEDIATRIC MAX BARRIER KIT-LF, Model Number DYNJ40306A; lll) HL VEIN STRIPPING PACK, Model Number DYNJ40374A; mmm) GENERAL USE PACK, Model Number DYNJ41137B; nnn) PICC LINE INSERTION WRO-LF, Model Number DYNJ41873B; ooo) CV ACCESS PACK WRO-LF, Model Number DYNJ41875B; ppp) RADIOLOGY PACK, Model Number DYNJ42172A; qqq) BASIC PACK, Model Number DYNJ42691; rrr) DRAINAGE TRAY, Model Number DYNJ42913; sss) DRAINAGE TRAY, Model Number DYNJ42913A; ttt) IR MINI KIT, Model Number DYNJ44519F; uuu) IR PERIPHERAL PACK, Model Number DYNJ45033A; vvv) EVLT CORE PACK, Model Number DYNJ45294; www) EVLT PACK, Model Number DYNJ45997C; xxx) PHLEBECTOMY PACK, Model Number DYNJ47502B; yyy) LINE KIT, Model Number DYNJ47987B; zzz) VEI
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 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
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| 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.