Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L; 2) GWIRE HYDRO 0.035 180CM AN... — FDA record Z-1829-2026

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 Feb 25, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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
Reason
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Classification
Class II
Recalling firm
Medline Industries, LP
Quantity
74,085 units
Agency-reported status
Ongoing
Source record identifier
Z-1829-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability1) 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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Apr 29, 2026
Recall initiation date
Feb 25, 2026
Center classification date
Apr 17, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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