CLASS II ONGOING Device recall · Reported 29 Apr 2026 · FDA Enforcement Report

Medline Namic Guidewires: Guidewire 3MMJ 0.035X260CM LT recalled

Medline Industries is recalling Medline Namic Guidewires: Guidewire 3MMJ 0.035X260CM LT, distributed nationwide in the US. The recall was initiated on 25 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125030001; 2) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125040001; 3) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBG562; 4) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBM956; 5) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 34124110001; 6) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 24LBR925; 7) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 25IDB410; 8) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 34124110001; 9) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23IBI440; 10) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23KBI254; 11) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABQ057; 12) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABR513; 13) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24GBL513; 14) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 25JDA853; 15) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 34124110001; 16) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23BBI300; 17) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24DBT361; 18) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24LBN513; 19) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 34124110001; 20) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBG409; 21) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBI536; 22) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBV499; 23) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 34124110001; 24) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 23BBE325; 25) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBF377; 26) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBP677; 27) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24EBT215; 28) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24FBB651; 29) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24GBN276; 30) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 25JDB022; 31) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 34124110001; 32) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23BBI328; 33) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23EBX142; 34) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24CBI166; 35) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24EBB935; 36) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 34125010001; 37) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24CBP092; 38) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24GBQ708; 39) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24LBN511; 40) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 25IDB409; 41) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125030001; 42) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125040001; 43) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25HDB501; 44) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA596; 45) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA852; 46) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 34125030001; 47) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25IDA121; 48) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA209; 49) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA844; 50) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDB021; 51) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23BBC807; 52) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBF993; 53) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBX235; 54) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23BBI326; 55) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23EBG136; 56) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23EBW407; 57) DYNJHWIRE102, UDI-DI: 10195327301606(each), 40195327301607(case), Lot Number: 23EBB276; 58) DYNJHWIRE106, UDI-DI: 10195327302153(each), 40195327302154(case), Lot Number: 23EBB277; 59) DYNJHWIRE106, UDI-DI: 10195327302153(each), 40195327302154(case), Lot Number: 23EBW406; 60) DYNJHWIRE110, UDI-DI: 10195327302214(each), 40195327302215(case), Lot Number: 23EBB278; 61) DYNJHWIRE110, UDI-DI: 10195327302214(each), 40195327302215(case), Lot Number: 23EBW408; 62) DYNJHWIRE121, UDI-DI: 10195327308421(each), 40195327308422(case), Lot Number: 23EBB283; 63) DYNJHWIRE121, UDI-DI: 10195327308421(each), 40195327308422(case), Lot Number: 23HBC832; 64) DYNJHWIRE121, UDI-DI: 10195327308421(each), 40195327308422(case), Lot Number: 23JBI897; 65) DYNJHWIRE122, UDI-DI: 10195327308438(each), 40195327308439(case), Lot Number: 23EBB284; 66) DYNJHWIRE122, UDI-DI: 10195327308438(each), 40195327308439(case), Lot Number: 23GBO917; 67) DYNJHWIRE118, UDI-DI: 10195327308308(each), 40195327308309(case), Lot Number: 23EBB286; 68) DYNJHWIRE127, UDI-DI: 10195327308704(each), 40195327308705(case), Lot Number: 23EBB289; 69) DYNJHWIRE130, UDI-DI: 10195327308797(each), 40195327308798(case), Lot Number: 23EBB291; 70) DYNJHWIRE130, UDI-DI: 10195327308797(each), 40195327308798(case), Lot Number: 23EBW417; 71) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23EBB293; 72) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23EBB296; 73) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23EBB312; 74) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23HBG331; 75) DYNJHWIRE124, UDI-DI: 10195327308506(each), 40195327308507(case), Lot Number: 23EBF995; 76) DYNJHWIRE124, UDI-DI: 10195327308506(each), 40195327308507(case), Lot Number: 23EBW413; 77) DYNJHWIRE116, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23EBT183; 78) DYNJHWIRE126, UDI-DI: 10195327308698(each), 40195327308699(case), Lot Number: 23EBW418; 79) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24ABA433; 80) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24CBT125; 81) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24EBC837; 82) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24FBK897; 83) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24GBL572; 84) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24LBN512; 85) DYNJHWIRE100, UDI-DI: 10195327301057(each), 40195327301058(case), Lot Number: 24DBT415; 86) DYNJHWIRE100, UDI-DI: 10195327301057(each), 40195327301058(case), Lot Number: 25CBT320; 87) DYNJHWIRE100, UDI-DI: 10195327301057(each), 40195327301058(case), Lot Number: 25IDA783; 88) DYNJHWIRE101, UDI-DI: 10195327301590(each), 40195327301591(case), Lot Number: 24GBX216; 89) DYNJHWIRE101, UDI-DI: 10195327301590(each), 40195327301591(case), Lot Number: 25JDA210; 90) DYNJHWIRE125, UDI-DI: 10195327308681(each), 40195327308682(case), Lot Number: 23EBW414; 91) DYNJHWIRE125, UDI-DI: 10195327308681(each), 40195327308682(case), Lot Number: 23EBB287; 92) DYNJHWIRE119, UDI-DI: 10195327308315(each), 40195327308316(case), Lot Number: 23EBB282; 93) DYNJHWIRE119, UDI-DI: 10195327308315(each), 40195327308316(case), Lot Number: 23EBW411; 94) DYNJHWIRE119, UDI-DI: 10195327308315(each), 40195327308316(case), Lot Number: 23GBG005; 95) DYNJHWIRE120, UDI-DI: 10195327308414(each), 40195327308415(case), Lot Number: 23EBW412; 96) DYNJHWIRE120, UDI-DI: 10195327308414(each), 40195327308415(case), Lot Number: 23EBF994

Quantity recalled74,085 units

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-1829-2026
FDA event ID: 98599
Recalling firm: Medline Industries, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 25 Feb 2026
FDA classified: 17 Apr 2026
Reported: 29 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

25 Feb 2026	Recall initiated by company
17 Apr 2026	Classified by FDA	+51 days
29 Apr 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Product as listed by the FDA

Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105; 3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: DYNJHWIRE107; 4) GWIRE HYDRO 0.035 260CM STR S, Model Number: DYNJHWIRE115; 5) GWIRE HYDRO 0.035 150CM STR, Model Number: DYNJHWIRE108; 6) GWIRE HYDRO 0.035 150CM ANG S, Model Number: DYNJHWIRE104; 7) GWIRE HYDRO 0.035 180CM STR S, Model Number: DYNJHWIRE113; 8) GWIRE HYDRO 0.035 260CM ANGLE, Model Number: DYNJHWIRE103; 9) GDWIRE .035INX150CM 3MMJ LT, Model Number: DYNJGWIRE01L; 10) GDWIRE .035INX180CM 3MMJ LT, Model Number: DYNJGWIRE03L; 11) GWIRE HYDRO 0.035 150CM STR S, Model Number: DYNJHWIRE112; 12) GWIRE HYDRO 0.035 180CM STR, Model Number: DYNJHWIRE109; 13) GWIRE HYDRO 0.035 210CM ANGLE, Model Number: DYNJHWIRE102; 14) GWIRE HYDRO 0.035 210CM ANG S, Model Number: DYNJHWIRE106; 15) GWIRE HYDRO 0.035 210CM STR, Model Number: DYNJHWIRE110; 16) GWIRE,HYDRO,0.038,180CM,ANG S, Model Number: DYNJHWIRE121; 17) GWIRE HYDRO 0.038 210CM ANG S, Model Number: DYNJHWIRE122; 18) GWIRE HYDRO 0.038 210CM ANGLE, Model Number: DYNJHWIRE118; 19) GWIRE HYDRO 0.038 260CM STR, Model Number: DYNJHWIRE127; 20) GWIRE,HYDRO,0.038,210CM,STR S, Model Number: DYNJHWIRE130; 21) GWIRE,HYDRO,0.038,260CM,ANG S, Model Number: DYNJHWIRE123; 22) GWIRE,HYDRO,0.038",150CM,STR, Model Number: DYNJHWIRE124; 23) GWIRE HYDRO 0.038 150CM ANGLE, Model Number: DYNJHWIRE116; 24) GWIRE,HYDRO,0.038",210CM,STR, Model Number: DYNJHWIRE126; 25) GWIRE HYDRO 0.035 260CM STR, Model Number: DYNJHWIRE111; 26) GWIRE HYDRO 0.035 150CM ANGLE, Model Number: DYNJHWIRE100; 27) GWIRE HYDRO 0.035 180CM ANGLE, Model Number: DYNJHWIRE101; 28) GWIRE,HYDRO,0.038",180CM, STR, Model Number: DYNJHWIRE125; 29) GWIRE HYDRO 0.038 260CM ANGLE, Model Number: DYNJHWIRE119; 30) GWIRE HYDRO 0.038 150CM ANG S, Model Number: DYNJHWIRE120

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Which lots are affected?

1) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125030001; 2) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 34125040001; 3) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBG562; 4) DYNJGWIRE20L, UDI-DI: 10195327188955(each), 40195327188956(case), Lot Number: 25DBM956; 5) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 34124110001; 6) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 24LBR925; 7) DYNJHWIRE105, UDI-DI: 10195327301637(each), 40195327301638(case), Lot Number: 25IDB410; 8) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 34124110001; 9) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23IBI440; 10) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 23KBI254; 11) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABQ057; 12) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24ABR513; 13) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 24GBL513; 14) DYNJHWIRE107, UDI-DI: 10195327302184(each), 40195327302185(case), Lot Number: 25JDA853; 15) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 34124110001; 16) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23BBI300; 17) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24DBT361; 18) DYNJHWIRE115, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 24LBN513; 19) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 34124110001; 20) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBG409; 21) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBI536; 22) DYNJHWIRE108, UDI-DI: 10195327302191(each), 40195327302192(case), Lot Number: 24DBV499; 23) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 34124110001; 24) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 23BBE325; 25) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBF377; 26) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24DBP677; 27) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24EBT215; 28) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24FBB651; 29) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 24GBN276; 30) DYNJHWIRE104, UDI-DI: 10195327301620(each), 40195327301621(case), Lot Number: 25JDB022; 31) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 34124110001; 32) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23BBI328; 33) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 23EBX142; 34) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24CBI166; 35) DYNJHWIRE113, UDI-DI: 10195327306007(each), 40195327306008(case), Lot Number: 24EBB935; 36) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 34125010001; 37) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24CBP092; 38) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24GBQ708; 39) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 24LBN511; 40) DYNJHWIRE103, UDI-DI: 10195327301613(each), 40195327301614(case), Lot Number: 25IDB409; 41) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125030001; 42) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 34125040001; 43) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25HDB501; 44) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA596; 45) DYNJGWIRE01L, UDI-DI: 10198459475368(each), 40198459475369(case), Lot Number: 25JDA852; 46) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 34125030001; 47) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25IDA121; 48) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA209; 49) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDA844; 50) DYNJGWIRE03L, UDI-DI: 10198459475375(each), 40198459475376(case), Lot Number: 25JDB021; 51) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23BBC807; 52) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBF993; 53) DYNJHWIRE112, UDI-DI: 10195327305994(each), 40195327305995(case), Lot Number: 23EBX235; 54) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23BBI326; 55) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23EBG136; 56) DYNJHWIRE109, UDI-DI: 10195327302207(each), 40195327302208(case), Lot Number: 23EBW407; 57) DYNJHWIRE102, UDI-DI: 10195327301606(each), 40195327301607(case), Lot Number: 23EBB276; 58) DYNJHWIRE106, UDI-DI: 10195327302153(each), 40195327302154(case), Lot Number: 23EBB277; 59) DYNJHWIRE106, UDI-DI: 10195327302153(each), 40195327302154(case), Lot Number: 23EBW406; 60) DYNJHWIRE110, UDI-DI: 10195327302214(each), 40195327302215(case), Lot Number: 23EBB278; 61) DYNJHWIRE110, UDI-DI: 10195327302214(each), 40195327302215(case), Lot Number: 23EBW408; 62) DYNJHWIRE121, UDI-DI: 10195327308421(each), 40195327308422(case), Lot Number: 23EBB283; 63) DYNJHWIRE121, UDI-DI: 10195327308421(each), 40195327308422(case), Lot Number: 23HBC832; 64) DYNJHWIRE121, UDI-DI: 10195327308421(each), 40195327308422(case), Lot Number: 23JBI897; 65) DYNJHWIRE122, UDI-DI: 10195327308438(each), 40195327308439(case), Lot Number: 23EBB284; 66) DYNJHWIRE122, UDI-DI: 10195327308438(each), 40195327308439(case), Lot Number: 23GBO917; 67) DYNJHWIRE118, UDI-DI: 10195327308308(each), 40195327308309(case), Lot Number: 23EBB286; 68) DYNJHWIRE127, UDI-DI: 10195327308704(each), 40195327308705(case), Lot Number: 23EBB289; 69) DYNJHWIRE130, UDI-DI: 10195327308797(each), 40195327308798(case), Lot Number: 23EBB291; 70) DYNJHWIRE130, UDI-DI: 10195327308797(each), 40195327308798(case), Lot Number: 23EBW417; 71) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23EBB293; 72) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23EBB296; 73) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23EBB312; 74) DYNJHWIRE123, UDI-DI: 10195327308490(each), 40195327308491(case), Lot Number: 23HBG331; 75) DYNJHWIRE124, UDI-DI: 10195327308506(each), 40195327308507(case), Lot Number: 23EBF995; 76) DYNJHWIRE124, UDI-DI: 10195327308506(each), 40195327308507(case), Lot Number: 23EBW413; 77) DYNJHWIRE116, UDI-DI: 10195327306021(each), 40195327306022(case), Lot Number: 23EBT183; 78) DYNJHWIRE126, UDI-DI: 10195327308698(each), 40195327308699(case), Lot Number: 23EBW418; 79) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24ABA433; 80) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24CBT125; 81) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24EBC837; 82) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24FBK897; 83) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24GBL572; 84) DYNJHWIRE111, UDI-DI: 10195327305987(each), 40195327305988(case), Lot Number: 24LBN512; 85) DYNJHWIRE100, UDI-DI: 10195327301057(each), 40195327301058(case), Lot Number: 24DBT415; 86) DYNJHWIRE100, UDI-DI: 10195327301057(each), 40195327301058(case), Lot Number: 25CBT320; 87) DYNJHWIRE100, UDI-DI: 10195327301057(each), 40195327301058(case), Lot Number: 25IDA783; 88) DYNJHWIRE101, UDI-DI: 10195327301590(each), 40195327301591(case), Lot Number: 24GBX216; 89) DYNJHWIRE101, UDI-DI: 10195327301590(each), 40195327301591(case), Lot Number: 25JDA210; 90) DYNJHWIRE125, UDI-DI: 10195327308681(each), 40195327308682(case), Lot Number: 23EBW414; 91) DYNJHWIRE125, UDI-DI: 10195327308681(each), 40195327308682(case), Lot Number: 23EBB287; 92) DYNJHWIRE119, UDI-DI: 10195327308315(each), 40195327308316(case), Lot Number: 23EBB282; 93) DYNJHWIRE119, UDI-DI: 10195327308315(each), 40195327308316(case), Lot Number: 23EBW411; 94) DYNJHWIRE119, UDI-DI: 10195327308315(each), 40195327308316(case), Lot Number: 23GBG005; 95) DYNJHWIRE120, UDI-DI: 10195327308414(each), 40195327308415(case), Lot Number: 23EBW412; 96) DYNJHWIRE120, UDI-DI: 10195327308414(each), 40195327308415(case), Lot Number: 23EBF994

Where was it sold?

US Nationwide distribution.

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

21 other products · FDA event 98599

This product is part of a recall event; the main page for the event is Medline Kits: Heart Transplant Biopsy recalled by Medline Industries.

Reported	Class	Recall	Company	Reason	Where
29 Apr 2026	CLASS II	Medline Kits: Heart Transplant Biopsy recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: CATH LAB CDS recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Angiography Pack-lf recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Hysteroscopy Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Mts Left Heart Kit-carolinas Hos recalled	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: ENT PACK recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Namic Syringes: Syr Cntrl Ring W/Rot NB recalled	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Breast Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Labor Pack-22025208-LF recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Syr Cntrl Ring W/Rot NB recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: General Laparoscopy recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Arthroscopy Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Bwnboro Craniotomy Pack-lf recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Newborn Admission recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Syringes: Syringe Control W/Rotator recalled	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Gyn Laparoscopy Pack recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Syr Control Rotating recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: PICC Tray recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Angio Cath Pack-mary Immaculat recalled	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: D AND C PACK recalled by Medline Industries	Medline Industries	Other	Nationwide
29 Apr 2026	CLASS II	Medline Kits: Arthrogram Tray recalled by Medline Industries	Medline Industries	Other	Nationwide

More recalls from Medline Industries

All 738

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Medline Drape C-section W/Pouch ST 7/CS, Medline Product Number recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as: Fetal Surgery Cds-lf recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline Drape C-section Fen Clr Screen W, Medline Product Number recalled	Medline Industries	Other	Nationwide
28 Oct 2026Device	CLASS II	Medline medical convenience kits labeled as: C-section Pack recalled	Medline Industries	Other	Nationwide

Other Heart & Vascular Devices recalls

All 6,268

Reported	Class	Recall	Company	Reason	Where
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Fathom/027/Straight/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/155 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/Straight/2RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide
28 Oct 2026Device	CLASS II	Direxion Torqueable Microcatheter, Ngmc/Single/021/J/1RO/130 recalled	Boston Scientific Cork	Device Malfunction	Nationwide