FreshRecalls

FDAClass II · Medical device · Recalled April 29, 2026

Medline Namic Guidewires recall — Medline Industries, LP

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The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.

Class II: may cause temporary or medically reversible health consequences.

Official recall ID
Z-1829-2026
Brand
Medline Industries
Classification
Class II
Units affected
74,085 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

Affected products

Companies & origin

Recalling firm location
Northfield, IL, United States
Firm address
3 Lakes Dr, N/A, 60093-2753

Identifying details (verbatim from the notice)

Product codes / lots
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
Distribution
US Nationwide distribution.
Firm notified the public via
Letter
FDA event ID
98599
Recall initiated
February 25, 2026
FDA classified
April 17, 2026
FDA report date
April 29, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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