CLASS II ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report
Medline Probe Cover Kits containing sterile Ultrasound Gel recalled
Medline Industries LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a), distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2164-2023
- FDA event ID
- 92466
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 May 2023
- FDA classified
- 20 Jul 2023
- Reported
- 26 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 18 May 2023 | Recall initiated by company | |
| 20 Jul 2023 | Classified by FDA | +63 days |
| 26 Jul 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DYNJ54153B; e) RFD-ENDOVASCULAR OR PACK, Model Number DYNJ54265A; f) PEDI EP PACK, Model Number DYNJ54750G; g) EL PASO VERICOSE VEIN PACK, Model Number DYNJ54803C; h) LEE VEIN PACK, Model Number DYNJ54906B; i) HEART FAILURE PK, Model Number DYNJ55528A; j) HEART FAILURE PK, Model Number DYNJ55528B; k) HEART FAILURE PK, Model Number DYNJ55528C; l) ROCKWAY VASCULAR PACK-LF, Model Number DYNJ55757C; m) OPEN HEART ANGIO PACK, Model Number DYNJ55836B; n) DR NACKMAN VEIN PACK, Model Number DYNJ56235; o) KT TAVR PACK, Model Number DYNJ56283D; p) KT TAVR PACK, Model Number DYNJ56283F; q) VEIN PACK, Model Number DYNJ56724B; r) VASCULAR PACK, Model Number DYNJ56791A; s) VASCULAR PACK, Model Number DYNJ56791B; t) ECMO PACK, Model Number DYNJ56904; u) VEIN KIT, Model Number DYNJ57047; v) EH TAVR PACK, Model Number DYNJ57449F; w) EH TAVR PACK, Model Number DYNJ57449G; x) VASCULAR PACK, Model Number DYNJ57490A; y) VEIN PACK, Model Number DYNJ57512; z) DEVICE PACK, Model Number DYNJ57595A; aa) CAROTID PACK-LF, Model Number DYNJ57646B; bb) CAROTID PACK-LF, Model Number DYNJ57646C; cc) CATH LAB PACK, Model Number DYNJ57735F; dd) VEIN PACK, Model Number DYNJ57835; ee) VEIN PACK, Model Number DYNJ57917; ff) ENS. THROMBOLYSE/EMBOLISAT-LF, Model Number DYNJ58179C; gg) HEART VALVE PACK, Model Number DYNJ58365J; hh) VEIN PACK, Model Number DYNJ58609; ii) VASCULAR PACK, Model Number DYNJ58681A; jj) VASCULAR PACK, Model Number DYNJ58681B; kk) VASCULAR PACK, Model Number DYNJ58710; ll) DR HARRISON VEIN PACK II, Model Number DYNJ59028A; mm) VEIN PACK, Model Number DYNJ59151F; nn) EP LAB, Model Number DYNJ59392D; oo) EP LAB, Model Number DYNJ59392F; pp) VEIN PACK, Model Number DYNJ59662D; qq) VEIN PACK, Model Number DYNJ59681A; rr) VASCULAR PACK CHRG, Model Number DYNJ59778B; ss) VASCULAR ACCESS KIT, Model Number DYNJ59796C; tt) CATH PACK, Model Number DYNJ59830A; uu) VENOUS ACCESS ACCESSORY PACK, Model Number DYNJ61010A; vv) DR SIRAGUSA VEIN PACK, Model Number DYNJ61247; ww) MAIN OR CATH LAB, Model Number DYNJ61373; xx) VASCULAR PACK, Model Number DYNJ61528; yy) VASCULAR PACK, Model Number DYNJ61528A; zz) VEIN PACK, Model Number DYNJ61540C; aaa) NEURO VASCULAR PACK, Model Number DYNJ61584A; bbb) ABLATION PACK, Model Number DYNJ61957A; ccc) HEART GROIN PACK, Model Number DYNJ61981C; ddd) PERMA CATH PACK, Model Number DYNJ62007B; eee) PURPLE PACK, Model Number DYNJ62197A; fff) PURPLE PACK, Model Number DYNJ62197B; ggg) CLOVIS CATH LAB PACK, Model Number DYNJ62379A; hhh) VASCULAR PACK, Model Number DYNJ62399A; iii) NORTH TEXAS VASCULAR, Model Number DYNJ62735; jjj) VEIN TRAY, Model Number DYNJ62829A; kkk) HEART VEIN NYC LASER ABLATION, Model Number DYNJ62850A; lll) HEART VEIN NYC -ARTERIAL PACK, Model Number DYNJ62851B; mmm) TAVR PACK, Model Number DYNJ62915B; nnn) PACER SET UP PACK, Model Number DYNJ63069A; ooo) OPEN HEART TAVR PACK, Model Number DYNJ63099D; ppp) OPEN HEART TAVR PACK, Model Number DYNJ63099F; qqq) ELECTROPHYSIOLOGY PACK, Model Number DYNJ63209; rrr) TAVR PACK, Model Number DYNJ63340A; sss) VEIN PACK, Model Number DYNJ63823; ttt) NIR PACK, Model Number DYNJ63892A; uuu) VEIN ABLATION TRAY W/CHLOR, Model Number DYNJ64396; vvv) TORRES-VEIN PACK, Model Number DYNJ64449; www) VEIN PACK, Model Number DYNJ64471A; xxx) CVOR ENDOVASCULAR PACK, Model Number DYNJ64506A; yyy) HEART FAILURE PACK, Model Number DYNJ64877B; zzz) CT ABLATION PACK, Model Number DYNJ64928; aaaa) VEIN PROCEDURE, Model Number DYNJ65342A; bbbb) SMALL TRAY VASCULAR PACK, Model Number DYNJ65418; cccc) VEIN OHH, Model Number DYNJ65560A; dddd) PORT PICC TUNNEL PACK, Model Number DYNJ65775A; eeee) VARITHENA PACK, Model Number DYNJ65
Where it was distributed
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
Questions about this recall
Why was it recalled?
Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Which lots are affected?
all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Numbers DYNJ53433K, UDI/DI (EA)10195327339487, UDI/DI (CS)40195327339488; b) Model Numbers DYNJ53616A, UDI/DI (EA)10889942688562, UDI/DI (CS)40889942688563; c) Model Numbers DYNJ54014B, UDI/DI (EA)10889942760329, UDI/DI (CS)40889942760320; d) Model Numbers DYNJ54153B, UDI/DI (EA)10889942714421, UDI/DI (CS)40889942714422; e) Model Numbers DYNJ54265A, UDI/DI (EA)10195327152338, UDI/DI (CS)40195327152339; f) Model Numbers DYNJ54750G, UDI/DI (EA)10195327021351, UDI/DI (CS)40195327021352; g) Model Numbers DYNJ54803C, UDI/DI (EA)10193489202618, UDI/DI (CS)40193489202619; h) Model Numbers DYNJ54906B, UDI/DI (EA)10193489289633, UDI/DI (CS)40193489289634; i) Model Numbers DYNJ55528A, UDI/DI (EA)10889942976638, UDI/DI (CS)40889942976639; j) Model Numbers DYNJ55528B, UDI/DI (EA)10195327046491, UDI/DI (CS)40195327046492; k) Model Numbers DYNJ55528C, UDI/DI (EA)10195327248208, UDI/DI (CS)40195327248209; l) Model Numbers DYNJ55757C, UDI/DI (EA)10195327116538, UDI/DI (CS)40195327116539; m) Model Numbers DYNJ55836B, UDI/DI (EA)10193489951172, UDI/DI (CS)40193489951173; n) Model Numbers DYNJ56235, UDI/DI (EA)10889942621552, UDI/DI (CS)40889942621553; o) Model Numbers DYNJ56283D, UDI/DI (EA)10195327093877, UDI/DI (CS)40195327093878; p) Model Numbers DYNJ56283F, UDI/DI (EA)10195327211851, UDI/DI (CS)40195327211852; q) Model Numbers DYNJ56724B, UDI/DI (EA)10193489466317, UDI/DI (CS)40193489466318; r) Model Numbers DYNJ56791A, UDI/DI (EA)10193489594119, UDI/DI (CS)40193489594110; s) Model Numbers DYNJ56791B, UDI/DI (EA)10195327045678, UDI/DI (CS)40195327045679; t) Model Numbers DYNJ56904, UDI/DI (EA)10889942693450, UDI/DI (CS)40889942693451; u) Model Numbers DYNJ57047, UDI/DI (EA)10889942710485, UDI/DI (CS)40889942710486; v) Model Numbers DYNJ57449F, UDI/DI (EA)10193489939200, UDI/DI (CS)40193489939201; w) Model Numbers DYNJ57449G, UDI/DI (EA)10195327064884, UDI/DI (CS)40195327064885; x) Model Numbers DYNJ57490A, UDI/DI (EA)10193489641998, UDI/DI (CS)40193489641999; y) Model Numbers DYNJ57512, UDI/DI (EA)10889942748273, UDI/DI (CS)40889942748274; z) Model Numbers DYNJ57595A, UDI/DI (EA)10193489622157, UDI/DI (CS)40193489622158; aa) Model Numbers DYNJ57646B, UDI/DI (EA)10193489828504, UDI/DI (CS)40193489828505; bb) Model Numbers DYNJ57646C, UDI/DI (EA)10195327287139, UDI/DI (CS)40195327287130; cc) Model Numbers DYNJ57735F, UDI/DI (EA)10193489629705, UDI/DI (CS)40193489629706; dd) Model Numbers DYNJ57835, UDI/DI (EA)10889942782338, UDI/DI (CS)40889942782339; ee) Model Numbers DYNJ57917, UDI/DI (EA)10889942794294, UDI/DI (CS)40889942794295; ff) Model Numbers DYNJ58179C, UDI/DI (EA)10195327209926, UDI/DI (CS)40195327209927; gg) Model Numbers DYNJ58365J, UDI/DI (EA)10195327019099, UDI/DI (CS)40195327019090; hh) Model Numbers DYNJ58609, UDI/DI (EA)10889942871261, UDI/DI (CS)40889942871262; ii) Model Numbers DYNJ58681A, UDI/DI (EA)10888277798489, UDI/DI (CS)40888277798480; jj) Model Numbers DYNJ58681B, UDI/DI (EA)10195327293376, UDI/DI (CS)40195327293377; kk) Model Numbers DYNJ58710, UDI/DI (EA)10889942880850, UDI/DI (CS)40889942880851; ll) Model Numbers DYNJ59028A, UDI/DI (EA)10193489736595, UDI/DI (CS)40193489736596; mm) Model Numbers DYNJ59151F, UDI/DI (EA)10193489487565, UDI/DI (CS)40193489487566; nn) Model Numbers DYNJ59392D, UDI/DI (EA)10195327053574, UDI/DI (CS)40195327053575; oo) Model Numbers DYNJ59392F, UDI/DI (EA)10195327135980, UDI/DI (CS)40195327135981; pp) Model Numbers DYNJ59662D, UDI/DI (EA)10195327030872, UDI/DI (CS)40195327030873; qq) Model Numbers DYNJ59681A, UDI/DI (EA)10193489469875, UDI/DI (CS)40193489469876; rr) Model Numbers DYNJ59778B, UDI/DI (EA)10193489695922, UDI/DI (CS)40193489695923; ss) Model Numbers DYNJ59796C, UDI/DI (EA)10193489904215, UDI/DI (CS)40193489904216; tt) Model Numbers DYNJ59830A, UDI/DI (EA)10193489570236, UDI/DI (CS)40193489570237; uu) Model Numbers DYNJ61010A, UDI/DI (EA)10193489307146, UDI/DI (CS)40193489307147; vv) Model Numbers DYNJ61247, UDI/DI (EA)10193489551709, UDI/DI (CS)40193489551700; ww) Model Numbers DYNJ61373, UDI/DI (EA)10193489576696, UDI/DI (CS)40193489576697; xx) Model Numbers DYNJ61528, UDI/DI (EA)10193489578980, UDI/DI (CS)40193489578981; yy) Model Numbers DYNJ61528A, UDI/DI (EA)10195327336714, UDI/DI (CS)40195327336715; zz) Model Numbers DYNJ61540C, UDI/DI (EA)10193489495126, UDI/DI (CS)40193489495127; aaa) Model Numbers DYNJ61584A, UDI/DI (EA)10193489812817, UDI/DI (CS)40193489812818; bbb) Model Numbers DYNJ61957A, UDI/DI (EA)10193489699074, UDI/DI (CS)40193489699075; ccc) Model Numbers DYNJ61981C, UDI/DI (EA)10195327106027, UDI/DI (CS)40195327106028; ddd) Model Numbers DYNJ62007B, UDI/DI (EA)10195327161965, UDI/DI (CS)40195327161966; eee) Model Numbers DYNJ62197A, UDI/DI (EA)10193489994094, UDI/DI (CS)40193489994095; fff) Model Numbers DYNJ62197B, UDI/DI (EA)10195327167240, UDI/DI (CS)40195327167241; ggg) Model Numbers DYNJ62379A, UDI/DI (EA)10195327196639, UDI/DI (CS)40195327196630; hhh) Model Numbers DYNJ62399A, UDI/DI (EA)10193489250268, UDI/DI (CS)40193489250269; iii) Model Numbers DYNJ62735, UDI/DI (EA)10193489685282, UDI/DI (CS)40193489685283; jjj) Model Numbers DYNJ62829A, UDI/DI (EA)10193489306620, UDI/DI (CS)40193489306621; kkk) Model Numbers DYNJ62850A, UDI/DI (EA)10193489784237, UDI/DI (CS)40193489784238; lll) Model Numbers DYNJ62851B, UDI/DI (EA)10193489271218, UDI/DI (CS)40193489271219; mmm) Model Numbers DYNJ62915B, UDI/DI (EA)10193489365351, UDI/DI (CS)40193489365352; nnn) Model Numbers DYNJ63069A, UDI/DI (EA)10193489423617, UDI/DI (CS)40193489423618; ooo) Model Numbers DYNJ63099D, UDI/DI (EA)10193489932690, UDI/DI (CS)40193489932691; ppp) Model Numbers DYNJ63099F, UDI/DI (EA)10195327150037, UDI/DI (CS)40195327150038; qqq) Model Numbers DYNJ63209, UDI/DI (EA)10193489727883, UDI/DI (CS)40193489727884; rrr) Model Numbers DYNJ63340A, UDI/DI (EA)10195327273583, UDI/DI (CS)40195327273584; sss) Model Numbers DYNJ63823, UDI/DI (EA)10193489763423, UDI/DI (CS)40193489763424; ttt) Model Numbers DYNJ63892A, UDI/DI (EA)10195327176518, UDI/DI (CS)40195327176519; uuu) Model Numbers DYNJ64396, UDI/DI (EA)10193489810509, UDI/DI (CS)40193489810500; vvv) Model Numbers DYNJ64449, UDI/DI (EA)10193489201574, UDI/DI (CS)40193489201575; www) Model Numbers DYNJ64471A, UDI/DI (EA)10193489414158, UDI/DI (CS)40193489414159; xxx) Model Numbers DYNJ64506A, UDI/DI (EA)10193489971064, UDI/DI (CS)40193489971065; yyy) Model Numbers DYNJ64877B, UDI/DI (EA)10193489415896, UDI/DI (CS)40193489415897; zzz) Model Numbers DYNJ64928, UDI/DI (EA)10193489231502, UDI/DI (CS)40193489231503; aaaa) Model Numbers DYNJ65342A, UDI/DI (EA)10193489369663, UDI/DI (CS)40193489369664; bbbb) Model Numbers DYNJ65418, UDI/DI (EA)10193489273717, UDI/DI (CS)40193489273718; cccc) Model Numbers DYNJ65560A, UDI/DI (EA)10193489397185, UDI/DI (CS)40193489397186; dddd) Model Numbers DYNJ65775A, UDI/DI (EA)10195327140229, UDI/DI (CS)40195327140220; eeee) Model Numbers DYNJ65842, UDI/DI (EA)10193489296310, UDI/DI (CS)40193489296311; ffff) Model Numbers DYNJ66076, UDI/DI (EA)10193489319231, UDI/DI (CS)40193489319232; gggg) Model Numbers DYNJ66152A, UDI/DI (EA)10193489820218, UDI/DI (CS)40193489820219; hhhh) Model Numbers DYNJ66152B, UDI/DI (EA)10195327090425, UDI/DI (CS)40195327090426; iiii) Model Numbers DYNJ66271C, UDI/DI (EA)10195327098506, UDI/DI (CS)40195327098507; jjjj) Model Numbers DYNJ66356C, UDI/DI (EA)10193489991055, UDI/DI (CS)40193489991056; kkkk) Model Numbers DYNJ66356D, UDI/DI (EA)10195327060299, UDI/DI (CS)40195327060290; llll) Model Numbers DYNJ66356G, UDI/DI (EA)10195327357306, UDI/DI (CS)40195327357307; mmmm) Model Numbers DYNJ66427, UDI/DI (EA)10193489354683, UDI/DI (CS)40193489354684; nnnn) Model Numbers DYNJ66445, UDI/DI (EA)10193489356083, UDI/DI (CS)40193489356084; oooo) Model Numbers DYNJ66743A, UDI/DI (EA)10193489435559, UDI/DI (CS)40193489435550; pppp) Model Numbers DYNJ66769, UDI/DI (EA)10193489380521, UDI/DI (CS)40193489380522; qqqq) Model Numbers DYNJ66916A, UDI/DI (EA)10193489993226, UDI/DI (CS)40193489993227; rrrr) Model Numbers DYNJ66926B, UDI/DI (EA)10195327340261, UDI/DI (CS)40195327340262; ssss) Model Numbers DYNJ67487B, UDI/DI (EA)10195327166144, UDI/DI (CS)40195327166145; tttt) Model Numbers DYNJ67487C, UDI/DI (EA)10195327260743, UDI/DI (CS)40195327260744; uuuu) Model Numbers DYNJ67517A, UDI/DI (EA)10193489462197, UDI/DI (CS)40193489462198; vvvv) Model Numbers DYNJ67725, UDI/DI (EA)10193489425840, UDI/DI (CS)40193489425841; wwww) Model Numbers DYNJ67750A, UDI/DI (EA)10193489832242, UDI/DI (CS)40193489832243; xxxx) Model Numbers DYNJ67750B, UDI/DI (EA)10193489912043, UDI/DI (CS)40193489912044; yyyy) Model Numbers DYNJ67750C, UDI/DI (EA)10195327341367, UDI/DI (CS)40195327341368; zzzz) Model Numbers DYNJ67770, UDI/DI (EA)10193489430714, UDI/DI (CS)40193489430715;
Where was it sold?
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
51 other products · FDA event 92466This product is part of a recall event; the main page for the event is Medline Probe Cover Kits containing sterile Ultrasound Gel recalled.
More recalls from Medline Industries LP - Northfield
All 792| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |