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Medline Namic Guidewires
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MEDICAL DEVICE RECALLMODERATE

Medline Namic Guidewires

Medline recalls Namic syringes, guidewires, and tubing due to rescinded 510(k) clearances.

What to do

Check your inventory for affected Medline Namic products and discontinue use immediately. Contact Medline Industries for instructions on returning the products and obtaining replacements or refunds.

Recalled
Listed
Updated
Recall No.
Z-1829-2026
Agency
FDA
Firm
Medline Industries, LP
Recall ID
98599
Status
ONGOING

Why it was recalled

Medline Industries is recalling certain Namic Control Syringes, Guidewires, and High-Pressure Tubing because the 510(k) regulatory clearances for these products have been rescinded. The affected products are included in various procedure kits and sold under the Medline Namic brand. A full list of affected model numbers is available on the FDA recall detail page.

Is mine affected?

This recall covers 262 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductLot codeModelUDI-DI
Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT34125030001, 34125040001, 25DBG562, 25DBM956DYNJGWIRE20L10195327188955
GWIRE HYDRO 0.035 180CM ANG S34124110001, 24LBR925, 25IDB410DYNJHWIRE10510195327301637
GWIRE HYDRO 0.035 260CM ANG S34124110001, 23IBI440, 23KBI254, 24ABQ057, 24ABR513, 24GBL513, 25JDA853DYNJHWIRE10710195327302184
GWIRE HYDRO 0.035 260CM STR S34124110001, 23BBI300, 24DBT361, 24LBN513DYNJHWIRE11510195327306021
GWIRE HYDRO 0.035 150CM STR34124110001, 24DBG409, 24DBI536, 24DBV499DYNJHWIRE10810195327302191
GWIRE HYDRO 0.035 150CM ANG S3412411000123BBE32524DBF37724DBP67724EBT21524FBB65124GBN27625JDB022DYNJHWIRE10410195327301620
GWIRE HYDRO 0.035 180CM STR S34124110001, 23BBI328, 23EBX142, 24CBI166, 24EBB935DYNJHWIRE11310195327306007
GWIRE HYDRO 0.035 260CM ANGLE34125010001, 24CBP092, 24GBQ708, 24LBN511, 25IDB409DYNJHWIRE10310195327301613
Show all 262 products
ProductLot codeModelUDI-DI
GDWIRE .035INX150CM 3MMJ LT34125030001, 34125040001, 25HDB501, 25JDA596, 25JDA852DYNJGWIRE01L10198459475368
GDWIRE .035INX180CM 3MMJ LT34125030001, 25IDA121, 25JDA209, 25JDA844, 25JDB021DYNJGWIRE03L10198459475375
GWIRE HYDRO 0.035 150CM STR S23BBC807, 23EBF993, 23EBX235DYNJHWIRE11210195327305994
GWIRE HYDRO 0.035 180CM STR23BBI326, 23EBG136, 23EBW407DYNJHWIRE10910195327302207
GWIRE HYDRO 0.035 210CM ANGLE23EBB276DYNJHWIRE10210195327301606
GWIRE HYDRO 0.035 210CM ANG S23EBB277, 23EBW406DYNJHWIRE10610195327302153
GWIRE HYDRO 0.035 210CM STR23EBB278, 23EBW408DYNJHWIRE11010195327302214
GWIRE,HYDRO,0.038,180CM,ANG S23EBB283, 23HBC832, 23JBI897DYNJHWIRE12110195327308421
GWIRE HYDRO 0.038 210CM ANG S23EBB284, 23GBO917DYNJHWIRE12210195327308438
GWIRE HYDRO 0.038 210CM ANGLE23EBB286DYNJHWIRE11810195327308308
GWIRE HYDRO 0.038 260CM STR23EBB289DYNJHWIRE12710195327308704
GWIRE,HYDRO,0.038,210CM,STR S23EBB291, 23EBW417DYNJHWIRE13010195327308797
GWIRE,HYDRO,0.038,260CM,ANG S23EBB293, 23EBB296, 23EBB312, 23HBG331DYNJHWIRE12310195327308490
GWIRE,HYDRO,0.038",150CM,STR23EBF995, 23EBW413DYNJHWIRE12410195327308506
GWIRE HYDRO 0.038 150CM ANGLE23EBT183DYNJHWIRE11610195327306021
GWIRE,HYDRO,0.038",210CM,STR23EBW418DYNJHWIRE12610195327308698
GWIRE HYDRO 0.035 260CM STR24ABA433, 24CBT125, 24EBC837, 24FBK897, 24GBL572, 24LBN512DYNJHWIRE11110195327305987
GWIRE HYDRO 0.035 150CM ANGLE24DBT415, 25CBT320, 25IDA783DYNJHWIRE10010195327301057
GWIRE HYDRO 0.035 180CM ANGLE24GBX216, 25JDA210DYNJHWIRE10110195327301590
GWIRE,HYDRO,0.038",180CM, STR23EBW414, 23EBB287DYNJHWIRE12510195327308681
GWIRE HYDRO 0.038 260CM ANGLE23EBB282, 23EBW411, 23GBG005DYNJHWIRE11910195327308315
GWIRE HYDRO 0.038 150CM ANG S23EBW412, 23EBF994DYNJHWIRE12010195327308414
Medline Namic Syringes: 1) SYR CNTRL 10ML RING W ROT NB25GBK394, 25GBN659, 25GBO446, 25GBO586, 25GBQ523DYNJSYR10CWRB10889942540570
Medline Syringes: 1) SYRINGE 12ML CONTROL W ROTATOR25ABF227, 25CBC537, 25EBK855, 25IDA120, 25IDA552, 25IDA648, 25IDB507DYNJSYR12CWR10884389676486
SYRINGE 10ML CONTROL W ROTATOR25EBH091, 25EBO178, 25IDA686, 25JDA207, 25JDB599DYNJSYR10CWR10884389672723
SYR CONTROL PAD 12ML L L25GBD528, 25JDB601DYNJSYR12CP10888277236615
TBG PRESS 72IN M F ROT BRAID25GBN402DYNJBRT72R10884389854211
SYRINGE 10ML CONTROL MLL25GBS345, 25GBS857, 25GBU045, 25GBV139DYNJSYR10C10884389676462
SYRINGE 8ML CONTROL MLL25IDB505DYNJSYR8C10884389676493
SYRINGE 12ML CONTROL MLL25IDB506, 25JDA208, 25JDB827DYNJSYR12C10884389676479
SYR CONTROL PAD 10ML L L ROT25JDA594DYNJSYR10CRP10888277236585
SYR CONTROL PAD 12ML L L ROT25JDB600DYNJSYR12CRP10888277236592
CTRL SYRINGE 6ML RING ROT L L25JDB602DYNJSYRC6CWR10889942885732
ANGIO CATH PACK-MARY IMMACULAT25CBA224DYNJ24517D10193489812510
SYR CNTRL 10ML RING W ROT NB22IBH07322IBH62022KBU23622LBB18623BBE16323BBQ24423BBT09423CBN15623DBO04723EBN96523FBG73023HBL27524BBT13324DBC91324DBM25324EBD05524EBM61924FBC81124GBO79224HBQ42924KBO16225ABL98425ABV25025BBC49625BBS71625BBU97925CBB63225CBC88025CBN32922JBU98123FBP99824JBO65625DBR721DYNJSYR10CWRB10889942540570
MANIFOLD KIT LOW PRESSURE OFF24KBI875, 23KBD992VASCSLPOFF110889942405527
EP MANIFOLD KIT25BBG137, 25BBI161, 25ABG686VASC1018A10889942337033
ANGIOGRAPHY PACK-LF23KBL880, 24ABA125, 23IBA898DYNJQ0505M10889942846900
ANGIO PACK24CMH245DYNJT2021G10193489608816
ANGIOGRAPHY PACK25LBQ639, 25GBF384DYNJ31377B10889942106691
ANGIO PACK25DBQ486, 25CBT538DYNJ5127910889942145300
ANGIOGRAPHY PACK II25FMA232DYNJ5244710889942279777
CATH ANGIO PACK25ILA917, 25FLA554DYNJ53369C10193489651331
ANGIO PACK25FBA222DYNJ53591A10889942592371
ANGIOGRAPHIC PACK21JBN53321KBM56321KBQ11021LBI45423DMF55923EMB05323FME91323JME01224BMK27224CMK04324CMK043Z24DMJ15624FMI06424HMB64324JME21223HME55125DMB495DYNJ5751610889942748426
ANGIOGRAPHY TRAY-LF25GBS720DYNJ58722A10193489329698
ANGIO TRAY W CHLORAPREP24KBE607DYNJ6274210193489685923
CEREBRAL ANGIOGRAM25KBP615DYNJ6787610193489449198
CSU CATH MANIFOLD KIT23GMC436VASC1170A10193489774863
CATH LAB CDS25ALA420, 25CLA774, 24LLA038CDS840228F10889942778546
IR PACK25DBR609DYNDH210410198459273964
CARDIAC CATH PACK-LF24JBT885DYNJT2164M10198459003165
ANGIOGRAPHY TRAY25DBN722DYNJT307810198459305146
CATH PACK25HBA387DYNJT419010198459428234
ANGIO VASCULAR PACK26ALA778DYNJT571710198459496684
HEART CATH PACK25JLA029DYNJ0381139R10198459276019
CARDIAC CATH PACK25JLA312DYNJ04529L10198459391460
CUSTOM RADIOLOGY PACK24HBM316, 23HBX895DYNJ07955L10889942628896
STVZ CARDIAC CATH PACK23DBP876, 23FBG933, 24GBE563, 24HBT787, 24KBC564, 24LBL445, 25DBF355, 25EBG106DYNJ24619J10195327295639
CATH TRAY #225BBB510DYNJ24706D10889942297122
CATH LAB PACK25DBJ212DYNJ24802Q10198459091476
CATH PACK25EMH059, 25FMA010, 25GME803DYNJ30268K10198459132636
HEART CATHETERIZATION PACK24JME497, 25AME060, 25CMA483, 25CMI507, 25DMB230, 25DMF455, 25EMB900, 25EMI646DYNJ30927R10195327539160
HEART CATH TRAY PACK-LF23JBA28823JBB35223LBC98324ABR89724EBQ35024FBM41324GBA09724HBU53824IBM28924JBJ56824LBL09225CBF56625DBG71724ABR60825EBA519DYNJ31944D10193489440171
CATH PACK-LF25BBJ181DYNJ33061D10193489841428
CATH PACK25LLA963DYNJ34638K10195327630614
ANGIOGRAPHY DRAPE PACK23JBL270, 23HBW572DYNJ38120C10193489979398
CATH PACK25ABD202, 25CBK291, 25EBB772, 25EBS985DYNJ40904G10195327650117
CARDIAC CATH-LF24FMB990DYNJ41057D10889942341764
CATH LAB PACK25DBJ237DYNJ4117210884389926567
ANGIOGRAPHY PACK24JBF696, 24KBD845, 24IBS009DYNJ42134G10195327644581
CATH LAB DRAPE PACK25JBU218DYNJ42455B10198459198441
ANGIOGRAPHY PACK25GLB081DYNJ42543B10198459026157
CATH LAB PACK21CBA55921DBB66321EME08421GMD91421IMC48521JMD38021LMA41821LMG01922GMA05922HMC84822IMG04922LMD90922LMD91022LMD91123DMD89923DMH72323GMI66323IMA32823IMH81623LMB74424BMC69024CME64324DMF29424DMH72224FMD72524GMH18624HMB85924JMC16524KMA53824KMD82825AMI40225BMC46325CMA55122DMD53523FMB30124GMA16425CME925DYNJ42900D10193489203028
ANGIOGRAPHY PACK NO SYR25BMH143, 25DMH529, 25DMK344, 25GMG243DYNJ43009K10198459243974
CATH PACK (WITH MANIFOLD)24JBB567, 25CBO965, 25CBT443, 25DBL293, 25EBK886, 25GBL828, 25KMF800DYNJ44515L10198459054518
ANGIO IR DRAPE PACK 31969625GBN239DYNJ44593I10198459280221
ANGIOGRAPHY DRAPE PACK23IBB504, 23JBJ153, 23KBP581, 25ABE986, 25BBO499, 25CBQ262, 25DBT178, 25GBK671DYNJ44850J10193489976342
CATH LAB PACK21ABF85321BBR42621DBG02521EBA97921GBJ60421IBN50621KBI79422ABH55622BBE82822EBL00522GBK92322GBK92422IBS86622JBW73022KBS65722OBI20323BBC59023CBS43423FBA28023GBE35623HBK67323JBT74323JBU44524ABT87024CBC65724CBS51124EBP12724GBQ82224HBH34324JBO86824KBS70624LBE18925ABP08225CBK76425DBH25725EBM03922CBP58923EBC27624FBR29525GBO282DYNJ4529610888277200784
ANGIO PACK25GBJ678DYNJ50739J10198459421785
CARDIAC CATH PACK25KDA536DYNJ51103F10193489985344
IR ANGIO BODY25GME161DYNJ51765D10198459308048
INTERVENTIONAL TRAY25GBN389DYNJ52501C10193489820461
CARDIAC CATH IMF 86040- LF24ELA39624ELA65024HLB18225ALA44825ALA80125BLA35025BLA40625DLB01225ELA05825FLA81925GLA62624GLA95525HLA56525KLA585DYNJ53947J10198459010545
CARDIAC CATH PACK23HBG21823HBZ25523JBC06923KBK08723LBG52924DBR59524FBM93824HBG26824IBL49924JBR90924KBU61524LBT55525BBT20825CBI70825EBK96625FBC61824GBS51425GBP762DYNJ54101I10195327394677
ANGIO KIT25CBK952DYNJ55686C10195327566470
CATH LAB PACK24IBH76824JBL74424JBT21424LBL45625BBH10225DBJ49725FBB11325HBB61625HBI90124HBK98425JBW313DYNJ56141B10198459069536
ANGIO NEURO PACK25GMB889DYNJ57685D10198459346552
CATH PACK25HBB613DYNJ57729F10198459395673
CATH PACK25LLA739DYNJ59632F10198459230097
CATH LAB PACK WITH NAMIC24DBR134DYNJ60853D10195327023966
ANGIO PACK ALEX25JBS069DYNJ63539C10198459323201
ANGIOGRAPHY CV RAD PACK22HBY85022LBQ52323ABK40823BBP11823EBI42423FBF15823GBM12423HBW85223JBA95423KBI35624BBO10924CBT86124EBG43024GBN95124GBV43324HBK33124KBI48524LBD30125ABL62725BBJ78825CBG88825FBB38023DBP20124FBA79825GBJ737DYNJ64936B10195327223205
CATH LAB PACK25CBA241DYNJ65185D10198459269509
CATH PACK25BMH948DYNJ65619A10195327427825
CATH I W SPLIT DRAPE PACK24DMA244DYNJ6618210193489320985
CATH PACK SHD24EBG456, 24FBN898, 24GBS573, 24IBL917, 24LBM711, 25CBU912, 24BBU798DYNJ68384B10195327341329
CATH LAB PACK25HBT584, 25JBK598, 25HBR477DYNJ69094B10195327567804
CATH LAB ACCESSORIES25GBJ711DYNJ69213B10198459001109
REYES CATH PACK24CBK985DYNJ69345A10195327227753
TMH ANGIOGRAPHY TRAY24ABS57224EBS23324FBT63824GBS64824IBU38124JBQ40324KBG05424LBJ08325BBK79125DBD99424CBU37025EBG388DYNJ80054A10195327516536
ANGIOGRAPHY TRAY22ABY00322DBN38322EBG31222JBT10722LBJ50222OBI37423CBV61123EBG61423FBT41023JBV58324ABU89224ABV45624FBG65724GBN00424HBD22324IBC15324KBH02625EBG39023IBG06225GBJ833DYNJ8015610195327012533
CATH PACK25LBF566DYNJ80516C10198459627002
CATH PACK25JBW545DYNJ8073010195327076313
ANGIO DRAPE PACK 2 WINDOW24IBV032, 24KBL790, 24HBX059DYNJ81066B10198459019609
OR ANGIOGRAM PACK25IBP952DYNJ81435F10198459434754
HEART CATH PACK25CBS792, 25EBR150DYNJ81527B10198459084935
HEART CATH PACK25IBU004, 25IBA135DYNJ83764D10198459067891
CATH LAB PACK25EBG981DYNJ84048A10195327350567
ANGIO TRAY NO LIDO25CBH200DYNJ85557B10198459140099
CARDIAC CATH PACK24KBG717, 24LBN809, 25BBA684, 25CBS896, 25EBB234, 25GBM051DYNJ85746B10198459187292
ANGIOGRAPHY PACK24JLA184, 24ILA638DYNJ8631310195327620011
ANGIOGRAPHY DRAPE PACK25CMD965, 24EMF718DYNJ8678710195327675165
CATH PACK25BBT130, 25CBR012, 25DBE588DYNJ87098A10198459273599
CATH LAB TAVR PACK25BMG293DYNJ8853210198459172366
SMT LEFT HEART CATH25BBT742DYNJ8927410198459258954
VASCULAR CATH PACK25GBU445DYNJ8935210198459269615
CATH LAB PACK25CBF895DYNJ8980510198459290756
CARDIAC CATH MERCY WASHINGTON25DMH974, 25EMJ512, 25GMG106DYNJ8993410198459305238
ANGIO25LLA045DYNJ900278G10195327554101
TAVR ICC VER. F25JDB197DYNJ904401F10198459566684
TAVR25IBL114DYNJ908646C10198459208898
LHK-UPMC CHILDRENS MAIN OR 225EMA601, 24AMF168NAM000910195327270742
KIT ANGIO CSTM-EVERGREEN25BBS852NAM002010195327403126
GP-CARDIAC CATH PACK-LF25KDA544PHS397170009D10198459506642
LEFT HEART KIT - MARION25CBI989VASC1073A10889942781881
RHK - VAMC RICHMOND25FBB593, 25EBK520VASC1185B10195327243395
LHK-MEADOWVIEW REG25GBM923VASC126310195327000080
LHK - BSC 3V ON S10RA25LBM049VASC126910193489962048
LHK - BSC 3V ON S10MLL22EBP401, 22EBB968VASC127010193489962055
MTS LEFT HEART KIT-CAROLINAS HOS183372, 1851906002177510193489041385
DBD-MTS LHK BHS BAPTIST. LOUISVI106008, 1173786002202610193489087253
MTO LEFT HEART KIT SUMMA BARBERT1761806002267310193489041538
MTS LH KIT-UNIV OF MIAMI PG1851936003081710193489041972
MTS LEFT HEART KIT SPRINGFIELD R1833746003124510193489042214
MTS PERIPHERAL KIT SPRINGFIELD R174370, 184424, 1850806003124710193489042238
MTS LEFT HEART KIT-COLISEUM MED1851956003192810193489042276
MTS LEFT HEART KIT -2-CALIFORNIA1813656003301110193489042429
MTS LEFT HEART KIT JOHN MUIR CON179872, 1833756004027310193489042832
MTS EP MANIFOLD KIT TEXAS HLTH P140365, 1700846004126810193489043051
MTS 3V MANIFOLD KIT-SPARROW HOSP1761866005009710193489043242
MTS LEFT HEART KIT FORT SANDERS183376, 185194, 1873706006038710193489043693
MTS LEFT HEART KIT-GOOD SAMARITA183377, 1873716007043510193489044133
DBD-MTS ANGIO KIT-MOUNT HOOD MED1851966007052110193489044164
MTS LFT HRT KIT-GRAND VIEW PG1761906007174310193489044348
MTS CUSTOM MANIFOLD KIT-INGALLS1851976009007810193489044829
MTS CATH LAB KIT - HEARTLAND PG181373, 1851986009054210193489044867
MTS LEFT HEART KIT-W.C.A PG176193, 1851896010007110193489044959
MTS MANIFOLD KIT-GENESYS REG MED1851886010025410193489045024
MTS 4V W PRO STA-ST.JOHNS REG ME181369, 1852036010043910193489045130
MTS LEFT HEART KIT JEANES HOSPIT1813646010177310193489045451
MTS LEFT HEART KIT-ST. MARYS OF181370, 1852046013109910193489046717
DBD-MTS LEFT HEART KIT-LEHIGH VA1813816013265310193489047332
MTS LEFT HEART KIT (3V DT WASTE)1852056013832610193489047653
MTS LF HRT KIT-PRESBYTERIAN UNIV183382, 1852076016014810193489048704
MTS LEFT HEART KIT-PENINSULA REG1811006016042810193489048773
MTS LEFT HEART KIT BARNES ST.PET177936, 1852086016113510193489049046
MTO OR ENDO KIT - PARK RIDGE HOS1403926016361810193489049251
MTS 3V W DT-CORPUS CHRISTI M.C.1852096018153110193489049619
MTS 3V PERC MANIFOLD KIT WEST. A185522, 1873436018213710193489049695
MTO CATH KIT PAMPA REGIONAL MED1762036018266110193489049794
MTO HOPKINS LEFT HEART HOWARD CO1813716018366210193489050080
MTS-CARDIOLOGY KIT-HARLINGEN MED177939, 1852106018400110193489050110
MTS PERCEPTOR KIT METHODIST. RIC1847396018543210193489050325
MTS LEFT HEART KIT SADDLEBACK ME1852126019131210193489050820
MTS-CARD MAN KIT MARIAN MED CENT1330646019427310193489051094
LEFT HEART KIT SOUTHERN HILLS HO181368, 1873746019520210193489051322
MTS DR KHAIRALLAH LEFT HEART KIT176208, 181375, 1852136020018910193489051513
MTS,4V,DIAG,KIT UNIV OF CONNECTICUT1873756021001410193489051766
MTO L H KIT-UNIV OF CLEVELAND -1813786021004710193489051797
MTS LEFT HEART KIT-BAPTIST HLTH1852146023050310193489053098
MTS CAN KIT ACCESSOIRE DIAGNOSTI1852156070052710193489057171
MTS LEFT HEART W SYRINGE-EMORY U18521760050371210193489070095
MTS ACCESSORY KIT SAINT JOSEPH L18522060101041210193489070613
MTS 3 PORT WHITE KIT LEESBURG RE17621260122271210193489070910
MTS PEDS LFT RT HRT-SUNRISE HO181379, 18522160190541410193489072105
MTS LHK ST. LOUIS CARDIO INST10675060611907210193489073461
LHK CENTURA HLTH CORP (ST. ANTHO184480601003036110193489108033
MTS LHK CHAMPLAIN VALLEY181376, 185223601012841110193489093728
MTS LHK VANDERBILT COFFEE HARTON185352, 185354601970592110193489096156
DBD-LHK EPIC SURGERY CENTER LLC155372602041058110193489131598
DBD-MTS LHK MS HEALTHCARE MGMT167702606107300110193489095692
LHK - WESLEY MEDICAL CENTER1852246010088152A10193489141276
IR ANGIOGRAPHY PACK-LF25KLA735DYNJVB1077D10198459589270
RADIOLOGY SPECIALS TRAY25LLA560, 25KLA369DYNJVB1302B10195327625429
ANGIO LEFT HEART PACK25JML198DYNJ40632D10198459198212
ANGIO RIGHT HEART PACK24KMG184, 25EMF185DYNJ40633C10198459198229
ANGIO TRAY25DBU258DYNJ43278C10193489957358
CARDIAC LEG PACK22ABO33322DBN25422IBJ53123ABN01723BBI30323DBG35523FBG33523GBR63223IBB71423JBU28824ABA04524BBH84924EBA78724FBN08324GBX93724IBU80424KBU07025ABB63725BBT27725DBL30622HBI76524BBE15725EBU657DYNJ44065C10195327080631
EP PACK22FBI713, 22FBR989, 23DBR938, 23DBR937DYNJ55512A10889942765003
VASCULAR PACK25CBC459DYNJ58522A10198459135781
PERIPHERAL CATH25JLA710DYNJ59220C10198459484551
CARDIAC CATH - NO SYR25CBD234DYNJ62409A10193489218671
C V MINOR PACK24IBJ708DYNJ64862B10195327053703
ENDOVASCULAR PACK21HBB19821IBK70721LBH26522ABZ74522EBO03122FBK91923ABG78423BBM27123DBJ19223EBF01523GBC29024BBH87424CBD05524DBO54124FBQ42724IBL34924KBE75624KBR81625DBI90921HBO23023EBS13925GBJ642DYNJ6592610193489305456
PICC TRAY25CLA242, 24LLA758DYNJ41648A10198459062834
HEART TRANSPLANT BIOPSY24DDA193DYNJ37543A10193489919561
ENT PACK24KBL574DYNJ59030B10198459176920
ENT24IBJ666, 24JBM014, 24KBE220, 24LBJ174, 25ABW145, 25CBK525, 25EBA897, 25GBK561DYNJ908586C10198459058677
LH 3 PORT W O WASTEBAG25FBA927VASC1081C10195327054519
GENERAL LAPAROSCOPY25EBE671CDS930027Y10198459303128
BREAST PACK24JBX593DYNJ66777D10195327365196
NEWBORN ADMISSION22GBJ869DYKB103810193489502428
DRAINAGE TRAY25DBF256DYNDA318810198459303579
VA ORLANDO SHOULDER PACK25ELA998, 25ELA723DYNJG001027B10198459065453
TUMESCENT SYRINGE KIT21BBH57921BBS21321DBS22021HBK17821IBV19421JBJ06321JBM58322ABG67822ABZ72422DBL34222IBS97822JBV88422LBH14122OBE02322OBE02422OBE02523CBP38923EBB42923EBQ43723GBB27823HBD98523JBN24223LBP03423LBP43224ABA41624EBF24424FBB64724FBO96024GBE24924GBW94724HBN43924JBC12324KBI92024LBO86021JBV36223BBU89024ABN98225HBM032DYNJTUMSYR10884389882054
OMC PTCA PACK25EBU996DYNJT371910198459347054
PORT PACK25HDB174DYNJT566710198459492129
WASTE MANAGEMENT KIT - 222HBK640DYNJWASTEKIT210193489548204
CARDIAC CATH25DMI117, 25BMC155DYNJ20175J10198459023750
D&C PACK-POB24FDB53424HDC00624IDB77024KDA88424LDA93825ADB52925BDB71925DDB45425HDA895DYNJ33521D10198459015656
BASIC PACK24DBD25124EBF80124FBD92524GBY00824HBN12724JBT02524KBF09524LBK22525BBA82725CBF94625DBH07025EBK90324GBC77625GBS410DYNJ38533F10195327609931
CATH PACK IMPLANT25BBB333, 25CBI608DYNJ39230D10198459223679
CERVICAL SPINE PACK25ELA632DYNJ40886B10193489768282
MV-IR ANGIO DRAPE PACK-LF25EMI492DYNJ41553F10198459079634
TV ENDOVASCULAR-LF25EMC747DYNJ41558D10889942811663
MAJOR PACK-LF24HBE996, 24IBD804, 24JBH568, 25EBR969DYNJ44816J10198459087318
ANGIOGRAPHY PACK24LBO769DYNJ48683A10889942491377
EXTREMITY PACK25FMA909, 25EMJ828DYNJ55922C10198459368318
NEURO PACK24BBN969DYNJ57785C10195327543624
PACEMAKER PACK24CBB17624DBR42224FBO63824HBT92724IBP96924JBH47324KBG03625CBH39625EBE869DYNJ61377B10195327592554
VASCULAR PACK24ABP681DYNJ62683D10195327556518
LINQ INSERTION PK W OUT LIDO24HME110DYNJ63668B10195327550851
BASIC PACK23BMD400, 23AMA569DYNJ8332410195327260781
OMF MINOR PACK24HBS684, 24JBP876, 24JBS147, 24LBL583, 25CBP938, 25DBQ919, 25FBD407DYNJ83991B10198459087325
ARTERIOGRAM SUMMIT PACK25BMG397DYNJ84040B10198459254161
HMWB NEURO NAMIC PACK25BBT025DYNJ8660010198459021565
VCH CARDIAC CATH PACK25ABL031DYNJ8906410198459230820
RADIOLOGY PACK25ABS218, 25BBC477, 25CBC491, 25DBC830DYNJ8908010198459232749
LITHOTOMY PACK25DBD397DYNJ8995910198459300912
AHT SPINE PACK25HBU069DYNJ903566D10195327560829
LAP21FBN72221HBI27421IBL09321KBE00921LBG33822GBZ02722JMB50722KMC06023BMF71923CME26623FMI18223GMI50923JME30223KMI13023LMH54024BMA15524GME96624IMC69024KMG55721GBO41123FMC75325GMD612DYNJ904576B10888277776760
EP MERCY JANESVILLE25FLA929DYNJ90701310193489318630
LHK, US, RUBY MEMORIAL HOSP24LBG464NAM003210195327694357
CHERIAN CATH KIT21DBF02921GBV04121IBQ15021KBK85621LBA32622CBX00522EBO96822HBF99122IBR90123ABL89623ABN26423DBA06923DBM49323EBH54523FBF98223HBE00723IBE86723JBW35324ABL39924CBB75024CBP94424EBQ24724FBB64424HBV20724KBI91225CBQ30525DBK90422JBD60423KBG28025EBH405VASC108610889942668144
RIGHT HEART KIT - LAKE NONA25EBV199, 24FBD352VASC112010889942816316
KIT ANGIO CSTM-SHAWNEE25EBM012, 25EBD891VASC115110889942937523
LEFT HEART KIT - OAKBEND25GBN921VASC115510888277760493
IR 2 PORT-ARROWHEAD REGIONAL23EBI565VASC140410195327366568
LHK - ARROWHEAD REGIONAL MED25GBS655, 25DBJ392VASC140510195327367015
LHK - UMC DOUBLE TRANSDUCER24LBH191VASC1415A10195327678272
SDMC, EP TWO PORT CUSTOM KIT24GBM95624HBN73424JBS22424LBL06125BBQ09725CBK25425CBN75625CBU91925DBG06724FBQ50825EBQ528VASC153310198459035623
ARTERIOGRAM TRAY25ABG557, 25BBE970, 25CBN926, 25EBD516, 25EBP91900-402001V10198459235269
SYR CONTROL 8ML ROTATING25BDB731DNSC8936910889942596225
ARTHROGRAM TRAY23DBP927, 23EBS362DYNJ0742510080196866465
TOL NEURO ANGIO PACK25DBM593, 25GBO740DYNJ38610I10198459323102
LABOR PACK-22025208-LF21CBJ47721GBE18421GBJ52721HBL38821IBT01321LBS71822BBD93522CBA26222FBM91022LBQ83823FBS83823IBD09923KBA05724ABJ74324EBG77624FBC22524IBW21524LBU05522HBG78225DBP554DYNJ44813D10193489467642
GYN LAPAROSCOPY PACK25GBL423DYNJ41257F10193489708523
HYSTEROSCOPY PACK24CBU779DYNJ48399C10195327172626
SLING PACK24BBS275DYNJ62849B10195327514884
D AND C PACK25FBA224DYNJ41254B10888277882003
BWNBORO CRANIOTOMY PACK-LF24CBF407DYNJ32841F10195327037796
CRANIOTOMY PACK-LF24KBG704DYNJ46069D10193489493184
ARTHROSCOPY PACK24BMD005DYNJ8244010195327196240

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-09-07 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification