CLASS II ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Medline procedure kits labeled as follows recalled

Medline Industries LP - Northfield is recalling Medline procedure kits labeled as follows: Combined Spinal And Epidural, distributed nationwide in the US. The recall was initiated on 16 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCodes: 1) DYNJRA1268B, UDI/DI 10193489370485 (each) 40193489370486 (case), Lot Numbers: 20FLA512, 20HLA422, 20ILA296, 20ILA327, 20LLA223, 21ALA087, 21CLA525; 2) DYNJRA1268C, UDI/DI 10193489905830 (each) 40193489905831 (case), Lot Numbers: 21ELA224, 21ELA333, 21GLA292, 21GLA895, 21HLA924, 21ILA773, 21JLA824, 22ALA237, 22BLA899, 22DLA197, 22DLA409, 22ELA583, 22ELB120, 22FLA820, 22FLB163, 22GLB081, 22HLA566, 22ILA092, 22LLA800, 23DLA368, 23FLA942, 23GLA321, 23HLA910, 23ILA593, 23JLA268; 3) DYNJRA1739A, UDI/DI 1019348992495 (each) 40193489924955 (case), Lot Numbers: 23CBE392; 4) DYNJRA1739B, UDI/DI 10195327411237 (each) 40195327411238 (case), Lot Numbers: 23FBL394, 23GBV201, 23HBG282, 23HBG968, 23IBQ191; 5) DYNJRA1869, UDI/DI 10195327018818 (each) 40195327018819 (case), Lot Numbers: 23CBE391; 6) DYNJRA9035, UDI/DI 10884389618448 (each) 40884389618449 (case), Lot Numbers: 22GBO435, 22IBI073, 23BBB167, 23BBS677, 23CBL304, 23FBI382; 7) DYNJRA9040, UDI/DI 10193489830514 (each) 40193489830515 (case), Lot Numbers: 23CBO446, 23DBK742, 23HBG091, 23HBG092; 8) EPIREINF19O, UDI/DI 10195327222970 (each) 40195327222971 (case), Lot Numbers: 22HBB281, 23EBO266, 23GBA230, 23HBN806, 23HBR131, 23HBY420; 9) EPIREINF29C, UDI/DI 10195327114367 (each) 40195327114368 (case), Lot Numbers: 22FBU886, 22HBD608, 22KBK655, 22NBE738, 23ABH589, 23DBK772, 23DBN448, 23JBU253; 10) PAIN0384B, UDI/DI 10193489926842 (each) 40193489926843 (case), Lot Numbers: 23BMC466, 23FMJ516, 23FMJ523, 23FMJ721, 23HMA617, 23LMB080, 23LMC430; 11) PAIN1069C, UDI/DI 1019532736489 (each) 40195327364893 (case), Lot Numbers: 23ELA637, 23GLA586, 23HLA616, 23JLB208; 12) PAIN1271A, UDI/DI 10193489619201 (each) 40193489619202 (case), Lot Numbers: 23BLA979; 13) PAIN1281B, UDI/DI 10195327288211 (each) 40195327288212 (case), Lot Numbers: 22KLA735, 23ALA157; 14) PAIN1317, UDI/DI 10888277797109 (each) 40888277797100 (case), Lot Numbers: 22GLA179, 22HLB332, 23CLA460, 23DLA279, 23ELB138, 23FLA944, 23GLA948, 23HLB106, 23ILA924, 23JLB213, 23KLB167; 15) PAIN1353B, UDI/DI 10193489336726 (each) 40193489336727 (case), Lot Numbers: 20ELA452; 16) PAIN1358, UDI/DI 10193489586749 (each) 40193489586740 (case), Lot Numbers: 22FLB088, 23CLA573; 17) PAIN1361, UDI/DI 10193489586848 (each) 40193489586849 (case), Lot Numbers: 22FLA642, 22GLA243, 23ILA612, 23JLA051; 18) PAIN1437A, UDI/DI 1019532713519 (each) 40195327135196 (case), Lot Numbers: 22EBA985, 23ABO995, 23KBH798, 23KBR650; 19) PAIN1453B, UDI/DI 1019532731038 (each) 40195327310388 (case), Lot Numbers: 22LLB007, 23ALA593, 23BLA987; 20) PAIN1536A, UDI/DI 10193489288582 (each) 40193489288583 (case), Lot Numbers: 23CLA081; 21) PAIN1547, UDI/DI 10193489813081 (each) 40193489813082 (case), Lot Numbers: 23BLB100, 23FLA069, 23JLA884; 22) PAIN1558, UDI/DI 10193489213584 (each) 40193489213585 (case), Lot Numbers: 23BMH883, 23GMA342, 23GMC058, 23IMC928; 23) PAIN1581A, UDI/DI 10195327351809 (each) 40195327351800 (case), Lot Numbers: 23BLB024, 23CLA024, 23ELB140; 24) PAIN1587A, UDI/DI 10193489336368 (each) 40193489336369 (case), Lot Numbers: 23BLA078, 23FLA277; 25) PAIN1587B, UDI/DI 10195327539511 (each) 40195327539512 (case), Lot Numbers: 23JLB184; 26) PAIN1605A, UDI/DI 1019348946814 (each) 40193489468145 (case), Lot Numbers: 22KLA748, 23BLA153; 27) PAIN1636, UDI/DI 10193489312720 (each) 40193489312721 (case), Lot Numbers: 22FLA297; 28) PAIN1644A, UDI/DI 10195327427863 (each) 40195327427864 (case), Lot Numbers: 23GLA589, 23HLA915, 23JLA225, 23KLA831; 29) PAIN1667A, UDI/DI 10193489472868 (each) 40193489472869 (case), Lot Numbers: 22FLB089, 23CLA442, 23ELA958, 23FLA945, 23HLA916, 23KLB169; 30) PAIN1709, UDI/DI 10193489816044 (each) 40193489816045 (case), Lot Numbers: 23CLA719; 31) PAIN1709A, UDI/DI 10195327411220 (each) 40195327411221 (case), Lot Numbers: 23ELA723, 23ILA927; 32) PAIN1766A, UDI/DI 10195327361488 (each) 40195327361489 (case), Lot Numbers: 23FLB123, 23GLA313; 33) PAIN1806, UDI/DI 10195327134563 (each) 40195327134564 (case), Lot Numbers: 22ELA290, 22FLB111; 34) PAIN1807, UDI/DI 1019532713502 (each) 40195327135028 (case), Lot Numbers: 22FLB112, 23DLA445; 35) PAIN1816, UDI/DI 10195327145453 (each) 40195327145454 (case), Lot Numbers: 22GLA509, 22GLA531; 36) PAIN1844, UDI/DI 10195327207748 (each) 40195327207749 (case), Lot Numbers: 23BLA981, 23ELB126, 23ILA404, 23ILB016; 37) PAIN1845, UDI/DI 10195327210823 (each) 40195327210824 (case), Lot Numbers: 23ELA640; 38) PAIN1846, UDI/DI 10195327211639 (each) 40195327211630 (case), Lot Numbers: 23DLA446; 39) PAIN1854, UDI/DI 10195327225858 (each) 40195327225859 (case), Lot Numbers: 22JLB193, 22LLA402; 40) PAIN1855, UDI/DI 10195327226015 (each) 40195327226016 (case), Lot Numbers: 22LLA455, 23CLA867; 41) PAIN1856, UDI/DI 10195327228996 (each) 40195327228997 (case), Lot Numbers: 22JLB162, 22LLA409; 42) PAIN1856A, UDI/DI 10195327338015 (each) 40195327338016 (case), Lot Numbers: 23HLB303; 43) PAIN1864, UDI/DI 10195327238766 (each) 40195327238767 (case), Lot Numbers: 22HLB077, 22LLA731, 23FLA012; 44) PAIN1864A, UDI/DI 10195327517090 (each) 40195327517091 (case), Lot Numbers: 23LLA277; 45) PAIN1878, UDI/DI 10195327257842 (each) 40195327257843 (case), Lot Numbers: 23ALA348, 23ELA724; 46) PAIN1885, UDI/DI 10195327269159 (each) 40195327269150 (case), Lot Numbers: 22LLA664, 23DLA281, 23ELA641; 47) PAIN1887, UDI/DI 10195327272852 (each) 40195327272853 (case), Lot Numbers: 22KLA920; 48) PAIN1888, UDI/DI 10195327272913 (each) 40195327272914 (case), Lot Numbers: 23BLA151, 23BLB105; 49) PAIN1890, UDI/DI 10195327282387 (each) 40195327282388 (case), Lot Numbers: 23BLB106; 50) PAIN1892, UDI/DI 10195327283049 (each) 40195327283040 (case), Lot Numbers: 23BLB026, 23ELB077, 23ILA928; 51) PAIN1893, UDI/DI 10195327283865 (each) 40195327283866 (case), Lot Numbers: 23BLA283, 23GLA624, 23HLA803; 52) PAIN1894, UDI/DI 10195327283896 (each) 40195327283897 (case), Lot Numbers: 23BLB107, 23ELA725, 23GLA370; 53) PAIN1898, UDI/DI 10195327297596 (each) 40195327297597 (case), Lot Numbers: 23BLA284, 23BLA726; 54) PAIN1904, UDI/DI 10195327312336 (each) 40195327312337 (case), Lot Numbers: 23ELB079, 23GLA947, 23HLA774; 55) PAIN1919, UDI/DI 10195327342807 (each) 40195327342808 (case), Lot Numbers: 23CLA461, 23GLB137, 23HLA653, 23ILA462; 56) PAIN1920, UDI/DI 10195327346072 (each) 40195327346073 (case), Lot Numbers: 23FLA827, 23HLA259; 57) PAIN1937, UDI/DI 10195327362737 (each) 40195327362738 (case), Lot Numbers: 23ELB122; 58) PAIN1940, UDI/DI 10195327365332 (each) 40195327365333 (case), Lot Numbers: 23ELB080; 59) PAIN1958, UDI/DI 10195327399986 (each) 40195327399987 (case), Lot Numbers: 23GBV335, 23IBL615; 60) PAIN1967, UDI/DI 10195327417482 (each) 40195327417483 (case), Lot Numbers: 23IDA109, 23KDB373; 61) PAIN2014, UDI/DI 10195327510763 (each) 40195327510764 (case), Lot Numbers: 23JBS142; 62) PAIN9025, UDI/DI 10193489777697 (each) 40193489777698 (case), Lot Numbers: 22FLB008, 22LLA741; 63) PAIN9026, UDI/DI 10193489777703 (each) 40193489777704 (case), Lot Numbers: 23ALA479, 23ALA534, 23ALA753, 23BLA647, 23BLB091, 23CLA295; 64) PAIN9028, UDI/DI 10193489295689 (each) 40193489295680 (case), Lot Numbers: 22GLA287, 22ILA124, 23CLA410; 65) PAIN9030, UDI/DI 10193489295641 (each) 40193489295642 (case), Lot Numbers: 22FLB009, 22HLB347, 22ILA078, 23CLA407; 66) PAIN9031, UDI/DI 10195327146429 (each) 40195327146420 (case), Lot Numbers: 22GLA057, 23ALA831, 23ELA887, 23GLA871; 67) PAIN9034, UDI/DI 10195327287757 (each) 40195327287758 (case), Lot Numbers: 23ABB439, 23ABG209, 23BBS341, 23CBO460, 23EBM262, 23EBR039, 23FBI376, 23FBI377; 68) PAIN9035, UDI/DI 10195327288006 (each) 40195327288007 (case), Lot Numbers: 23BBP889; 69) PAIN9036, UDI/DI 10195327288013 (each) 40195327288014 (case), Lot Numbers: 23BBN205, 23GBW665, 23HBQ304, 23HBU314, 23JBO472; 70) REPICATH19, UDI/DI 10193489630848 (each) 40193489630849 (case), Lot Numbers: 22ABM967, 22GBG329, 22HBO372, 23CBI450, 23GBI168, 23GBI169, 23GBI170, 23HBI971; 71) SAMPA0105, UDI/DI 10195327026240 (each) 40195327026241 (case), Lot Numbers: 21JLA580; 72) SAMPA0106, UDI/DI 10195327028169 (each) 40195327028160 (case), Lot Numbers: 21LBY057; 73) SAMPA0110, UDI/DI 10195327097004 (each) 40195327097005 (case), Lot Numbers: 22BLA107, 22CLA719, 22CLA850; 74) SAMPA0111, UDI/DI 10195327204693 (each) 40195327204694 (case), Lot Numbers: 22LLA665

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-0509-2025
FDA event ID: 95615
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 16 Oct 2024
FDA classified: 22 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

16 Oct 2024	Recall initiated by company
22 Nov 2024	Classified by FDA	+37 days
4 Dec 2024	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 connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

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 procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268B; 2) COMBINED SPINAL AND EPIDURAL, REF DYNJRA1268C; 3) FEMORAL BLOCK TRAY, REF DYNJRA1739A; 4) FEMORAL BLOCK TRAY, REF DYNJRA1739B; 5) 18G CPNB 20G STYLETED CATHETER, REF DYNJRA1869; 6) CONT EPID 18G NDL/20G CATH, REF DYNJRA9035; 7) TRAY 18G CPNB 20G STYLETED, REF DYNJRA9040; 8) CATHETER REINF W/ CONNECT OT, REF EPIREINF19O; 9) CATHETER REINF WITH CONNECTOR, REF EPIREINF29C; 10) CONTINUOUS EPIDURAL UPDATED, REF PAIN0384B; 11) CONT EPI 20G W/HUSTEAD, REF PAIN1069C; 12) CONTINUOUS EPIDURAL, REF PAIN1271A; 13) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281B; 14) CONTINUOUS EPIDURAL TRAY, REF PAIN1317; 15) 20G CONT. EPID TRAY, REF PAIN1353B; 16) CONTINUOUS EPIDURAL TRAY, REF PAIN1358; 17) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1361; 18) JHAC CONT EPIDURAL, REF PAIN1437A; 19) CONTINUOUS EPIDURAL TRAY, REF PAIN1453B; 20) EPIDURAL CATH KIT, REF PAIN1536A; 21) CONTINUOUS EPIDURAL TRAY, REF PAIN1547; 22) EPIDURAL TRAY, REF PAIN1558; 23) CONTINUOUS EPIDURAL, REF PAIN1581A; 24) CONTINUOUS EPIDURAL TRAY, REF PAIN1587A; 25) CONTINUOUS EPIDURAL TRAY, REF PAIN1587B; 26) CONTINUOUS EPIDURAL TRAY, REF PAIN1605A; 27) CONTINUOUS EPIDURAL TRAY, REF PAIN1636; 28) EPIDURAL CATHETERIZATION KIT, REF PAIN1644A; 29) CONTINUOUS EPIDURAL TRAY, REF PAIN1667A; 30) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709; 31) CONT. EPIDURAL TRAY - NYLON, REF PAIN1709A; 32) CONTINUOUS EPIDURAL, REF PAIN1766A; 33) PEDIATRIC EPIDURAL TRAY, REF PAIN1806; 34) EPIDURAL TRAY IMF 103130, REF PAIN1807; 35) CONTINUOUS EPIDURAL TRAY, REF PAIN1816; 36) CONTINUOUS EPIDURAL, REF PAIN1844; 37) CSE TRAY, REF PAIN1845; 38) BWH L&D EPIDURAL KIT, REF PAIN1846; 39) 17G CONT. EPI - MRI SAFE, REF PAIN1854; 40) 17G L&D CONT. EPIDURAL, REF PAIN1855; 41) CONTINUOUS/CSE TRAY, REF PAIN1856; 42) CONTINUOUS/CSE TRAY, REF PAIN1856A; 43) CONTINUOUS EPIDURAL TRAY, REF PAIN1864; 44) CONTINUOUS EPIDURAL TRAY, REF PAIN1864A; 45) CONTINUOUS EPIDURAL TRAY, REF PAIN1878; 46) CSE TRAY, REF PAIN1885; 47) TEAM HEALTH EPIDURAL, REF PAIN1887; 48) SOUND ANESTHESIA EPIDURAL, REF PAIN1888; 49) CONTINUOUS EPIDURAL TRAY, REF PAIN1890; 50) CONTINUOUS EPIDURAL TRAY, REF PAIN1892; 51) UAMS CONTINUOUS EPIDURAL, REF PAIN1893; 52) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN1894; 53) CSE TRAY, REF PAIN1898; 54) CSE TRAY, REF PAIN1904; 55) 17/25G CSE TRAY, REF PAIN1919; 56) CSE TRAY, REF PAIN1920; 57) 17/25G CSE TRAY, REF PAIN1937; 58) CONTINUOUS EPIDURAL TRAY, REF PAIN1940; 59) COMBINED SPINAL EPIDURAL TRAY, REF PAIN1958; 60) REINFORCED CATH EPIDURAL TRAY, REF PAIN1967; 61) OPEN TIP EPIDURAL CATH TRAY, REF PAIN2014; 62) TRAY,CON,EPID,19G REINF,W/TUOH, REF PAIN9025; 63) TRAY,CON,EPID,19G REINF,W/O RX, REF PAIN9026; 64) CSE 17G HUSTEAD 27G WHIT W/RX, REF PAIN9028; 65) 17G CONT EPIDURAL NYLON, REF PAIN9030; 66) TRAY,CON EPID,19G REINF OPNTIP, REF PAIN9031; 67) 19G REINF CATH LIDO/NACL ONLY, REF PAIN9034; 68) 20G NYLON CATH LIDO/NACL ONLY, REF PAIN9035; 69) 17GHUST 27GWHIT LIDO/NACL ONLY, REF PAIN9036; 70) REINIF 19G EPI CATH S STERILE, REF REPICATH19; 71) CONT. EPIDURAL TRAY, REF SAMPA0105; 72) EPIDURAL CATH PACK, REF SAMPA0106; 73) CONTINUOUS EPIDURAL TRAY, REF SAMPA0110; 74) CONTINUOUS EPIDURAL TRAY, REF SAMPA0111

Where it was distributed

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

Nationwide

Questions about this recall

Why was it recalled?

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Which lots are affected?

Codes: 1) DYNJRA1268B, UDI/DI 10193489370485 (each) 40193489370486 (case), Lot Numbers: 20FLA512, 20HLA422, 20ILA296, 20ILA327, 20LLA223, 21ALA087, 21CLA525; 2) DYNJRA1268C, UDI/DI 10193489905830 (each) 40193489905831 (case), Lot Numbers: 21ELA224, 21ELA333, 21GLA292, 21GLA895, 21HLA924, 21ILA773, 21JLA824, 22ALA237, 22BLA899, 22DLA197, 22DLA409, 22ELA583, 22ELB120, 22FLA820, 22FLB163, 22GLB081, 22HLA566, 22ILA092, 22LLA800, 23DLA368, 23FLA942, 23GLA321, 23HLA910, 23ILA593, 23JLA268; 3) DYNJRA1739A, UDI/DI 1019348992495 (each) 40193489924955 (case), Lot Numbers: 23CBE392; 4) DYNJRA1739B, UDI/DI 10195327411237 (each) 40195327411238 (case), Lot Numbers: 23FBL394, 23GBV201, 23HBG282, 23HBG968, 23IBQ191; 5) DYNJRA1869, UDI/DI 10195327018818 (each) 40195327018819 (case), Lot Numbers: 23CBE391; 6) DYNJRA9035, UDI/DI 10884389618448 (each) 40884389618449 (case), Lot Numbers: 22GBO435, 22IBI073, 23BBB167, 23BBS677, 23CBL304, 23FBI382; 7) DYNJRA9040, UDI/DI 10193489830514 (each) 40193489830515 (case), Lot Numbers: 23CBO446, 23DBK742, 23HBG091, 23HBG092; 8) EPIREINF19O, UDI/DI 10195327222970 (each) 40195327222971 (case), Lot Numbers: 22HBB281, 23EBO266, 23GBA230, 23HBN806, 23HBR131, 23HBY420; 9) EPIREINF29C, UDI/DI 10195327114367 (each) 40195327114368 (case), Lot Numbers: 22FBU886, 22HBD608, 22KBK655, 22NBE738, 23ABH589, 23DBK772, 23DBN448, 23JBU253; 10) PAIN0384B, UDI/DI 10193489926842 (each) 40193489926843 (case), Lot Numbers: 23BMC466, 23FMJ516, 23FMJ523, 23FMJ721, 23HMA617, 23LMB080, 23LMC430; 11) PAIN1069C, UDI/DI 1019532736489 (each) 40195327364893 (case), Lot Numbers: 23ELA637, 23GLA586, 23HLA616, 23JLB208; 12) PAIN1271A, UDI/DI 10193489619201 (each) 40193489619202 (case), Lot Numbers: 23BLA979; 13) PAIN1281B, UDI/DI 10195327288211 (each) 40195327288212 (case), Lot Numbers: 22KLA735, 23ALA157; 14) PAIN1317, UDI/DI 10888277797109 (each) 40888277797100 (case), Lot Numbers: 22GLA179, 22HLB332, 23CLA460, 23DLA279, 23ELB138, 23FLA944, 23GLA948, 23HLB106, 23ILA924, 23JLB213, 23KLB167; 15) PAIN1353B, UDI/DI 10193489336726 (each) 40193489336727 (case), Lot Numbers: 20ELA452; 16) PAIN1358, UDI/DI 10193489586749 (each) 40193489586740 (case), Lot Numbers: 22FLB088, 23CLA573; 17) PAIN1361, UDI/DI 10193489586848 (each) 40193489586849 (case), Lot Numbers: 22FLA642, 22GLA243, 23ILA612, 23JLA051; 18) PAIN1437A, UDI/DI 1019532713519 (each) 40195327135196 (case), Lot Numbers: 22EBA985, 23ABO995, 23KBH798, 23KBR650; 19) PAIN1453B, UDI/DI 1019532731038 (each) 40195327310388 (case), Lot Numbers: 22LLB007, 23ALA593, 23BLA987; 20) PAIN1536A, UDI/DI 10193489288582 (each) 40193489288583 (case), Lot Numbers: 23CLA081; 21) PAIN1547, UDI/DI 10193489813081 (each) 40193489813082 (case), Lot Numbers: 23BLB100, 23FLA069, 23JLA884; 22) PAIN1558, UDI/DI 10193489213584 (each) 40193489213585 (case), Lot Numbers: 23BMH883, 23GMA342, 23GMC058, 23IMC928; 23) PAIN1581A, UDI/DI 10195327351809 (each) 40195327351800 (case), Lot Numbers: 23BLB024, 23CLA024, 23ELB140; 24) PAIN1587A, UDI/DI 10193489336368 (each) 40193489336369 (case), Lot Numbers: 23BLA078, 23FLA277; 25) PAIN1587B, UDI/DI 10195327539511 (each) 40195327539512 (case), Lot Numbers: 23JLB184; 26) PAIN1605A, UDI/DI 1019348946814 (each) 40193489468145 (case), Lot Numbers: 22KLA748, 23BLA153; 27) PAIN1636, UDI/DI 10193489312720 (each) 40193489312721 (case), Lot Numbers: 22FLA297; 28) PAIN1644A, UDI/DI 10195327427863 (each) 40195327427864 (case), Lot Numbers: 23GLA589, 23HLA915, 23JLA225, 23KLA831; 29) PAIN1667A, UDI/DI 10193489472868 (each) 40193489472869 (case), Lot Numbers: 22FLB089, 23CLA442, 23ELA958, 23FLA945, 23HLA916, 23KLB169; 30) PAIN1709, UDI/DI 10193489816044 (each) 40193489816045 (case), Lot Numbers: 23CLA719; 31) PAIN1709A, UDI/DI 10195327411220 (each) 40195327411221 (case), Lot Numbers: 23ELA723, 23ILA927; 32) PAIN1766A, UDI/DI 10195327361488 (each) 40195327361489 (case), Lot Numbers: 23FLB123, 23GLA313; 33) PAIN1806, UDI/DI 10195327134563 (each) 40195327134564 (case), Lot Numbers: 22ELA290, 22FLB111; 34) PAIN1807, UDI/DI 1019532713502 (each) 40195327135028 (case), Lot Numbers: 22FLB112, 23DLA445; 35) PAIN1816, UDI/DI 10195327145453 (each) 40195327145454 (case), Lot Numbers: 22GLA509, 22GLA531; 36) PAIN1844, UDI/DI 10195327207748 (each) 40195327207749 (case), Lot Numbers: 23BLA981, 23ELB126, 23ILA404, 23ILB016; 37) PAIN1845, UDI/DI 10195327210823 (each) 40195327210824 (case), Lot Numbers: 23ELA640; 38) PAIN1846, UDI/DI 10195327211639 (each) 40195327211630 (case), Lot Numbers: 23DLA446; 39) PAIN1854, UDI/DI 10195327225858 (each) 40195327225859 (case), Lot Numbers: 22JLB193, 22LLA402; 40) PAIN1855, UDI/DI 10195327226015 (each) 40195327226016 (case), Lot Numbers: 22LLA455, 23CLA867; 41) PAIN1856, UDI/DI 10195327228996 (each) 40195327228997 (case), Lot Numbers: 22JLB162, 22LLA409; 42) PAIN1856A, UDI/DI 10195327338015 (each) 40195327338016 (case), Lot Numbers: 23HLB303; 43) PAIN1864, UDI/DI 10195327238766 (each) 40195327238767 (case), Lot Numbers: 22HLB077, 22LLA731, 23FLA012; 44) PAIN1864A, UDI/DI 10195327517090 (each) 40195327517091 (case), Lot Numbers: 23LLA277; 45) PAIN1878, UDI/DI 10195327257842 (each) 40195327257843 (case), Lot Numbers: 23ALA348, 23ELA724; 46) PAIN1885, UDI/DI 10195327269159 (each) 40195327269150 (case), Lot Numbers: 22LLA664, 23DLA281, 23ELA641; 47) PAIN1887, UDI/DI 10195327272852 (each) 40195327272853 (case), Lot Numbers: 22KLA920; 48) PAIN1888, UDI/DI 10195327272913 (each) 40195327272914 (case), Lot Numbers: 23BLA151, 23BLB105; 49) PAIN1890, UDI/DI 10195327282387 (each) 40195327282388 (case), Lot Numbers: 23BLB106; 50) PAIN1892, UDI/DI 10195327283049 (each) 40195327283040 (case), Lot Numbers: 23BLB026, 23ELB077, 23ILA928; 51) PAIN1893, UDI/DI 10195327283865 (each) 40195327283866 (case), Lot Numbers: 23BLA283, 23GLA624, 23HLA803; 52) PAIN1894, UDI/DI 10195327283896 (each) 40195327283897 (case), Lot Numbers: 23BLB107, 23ELA725, 23GLA370; 53) PAIN1898, UDI/DI 10195327297596 (each) 40195327297597 (case), Lot Numbers: 23BLA284, 23BLA726; 54) PAIN1904, UDI/DI 10195327312336 (each) 40195327312337 (case), Lot Numbers: 23ELB079, 23GLA947, 23HLA774; 55) PAIN1919, UDI/DI 10195327342807 (each) 40195327342808 (case), Lot Numbers: 23CLA461, 23GLB137, 23HLA653, 23ILA462; 56) PAIN1920, UDI/DI 10195327346072 (each) 40195327346073 (case), Lot Numbers: 23FLA827, 23HLA259; 57) PAIN1937, UDI/DI 10195327362737 (each) 40195327362738 (case), Lot Numbers: 23ELB122; 58) PAIN1940, UDI/DI 10195327365332 (each) 40195327365333 (case), Lot Numbers: 23ELB080; 59) PAIN1958, UDI/DI 10195327399986 (each) 40195327399987 (case), Lot Numbers: 23GBV335, 23IBL615; 60) PAIN1967, UDI/DI 10195327417482 (each) 40195327417483 (case), Lot Numbers: 23IDA109, 23KDB373; 61) PAIN2014, UDI/DI 10195327510763 (each) 40195327510764 (case), Lot Numbers: 23JBS142; 62) PAIN9025, UDI/DI 10193489777697 (each) 40193489777698 (case), Lot Numbers: 22FLB008, 22LLA741; 63) PAIN9026, UDI/DI 10193489777703 (each) 40193489777704 (case), Lot Numbers: 23ALA479, 23ALA534, 23ALA753, 23BLA647, 23BLB091, 23CLA295; 64) PAIN9028, UDI/DI 10193489295689 (each) 40193489295680 (case), Lot Numbers: 22GLA287, 22ILA124, 23CLA410; 65) PAIN9030, UDI/DI 10193489295641 (each) 40193489295642 (case), Lot Numbers: 22FLB009, 22HLB347, 22ILA078, 23CLA407; 66) PAIN9031, UDI/DI 10195327146429 (each) 40195327146420 (case), Lot Numbers: 22GLA057, 23ALA831, 23ELA887, 23GLA871; 67) PAIN9034, UDI/DI 10195327287757 (each) 40195327287758 (case), Lot Numbers: 23ABB439, 23ABG209, 23BBS341, 23CBO460, 23EBM262, 23EBR039, 23FBI376, 23FBI377; 68) PAIN9035, UDI/DI 10195327288006 (each) 40195327288007 (case), Lot Numbers: 23BBP889; 69) PAIN9036, UDI/DI 10195327288013 (each) 40195327288014 (case), Lot Numbers: 23BBN205, 23GBW665, 23HBQ304, 23HBU314, 23JBO472; 70) REPICATH19, UDI/DI 10193489630848 (each) 40193489630849 (case), Lot Numbers: 22ABM967, 22GBG329, 22HBO372, 23CBI450, 23GBI168, 23GBI169, 23GBI170, 23HBI971; 71) SAMPA0105, UDI/DI 10195327026240 (each) 40195327026241 (case), Lot Numbers: 21JLA580; 72) SAMPA0106, UDI/DI 10195327028169 (each) 40195327028160 (case), Lot Numbers: 21LBY057; 73) SAMPA0110, UDI/DI 10195327097004 (each) 40195327097005 (case), Lot Numbers: 22BLA107, 22CLA719, 22CLA850; 74) SAMPA0111, UDI/DI 10195327204693 (each) 40195327204694 (case), Lot Numbers: 22LLA665

Where was it sold?

US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands

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

7 other products · FDA event 95615

This product is part of a recall event; the main page for the event is Medline procedure kits labeled as follows: Cont Epi W/Hustead recalled.

Reported	Class	Recall	Company	Reason	Where
4 Dec 2024	CLASS II	Medline procedure kits labeled as follows: Cont Epi W/Hustead recalled	Medline Industries LP - Northfield	Device Malfunction	Nationwide
4 Dec 2024	CLASS II	Medline procedure kits labeled as follows: Epi Cath Single Sterile recalled	Medline Industries LP - Northfield	Device Malfunction	Nationwide
4 Dec 2024	CLASS II	Medline procedure kits labeled as follows: Echostim Block Set recalled	Medline Industries LP - Northfield	Device Malfunction	Nationwide
4 Dec 2024	CLASS II	Medline procedure kits labeled as follows recalled	Medline Industries LP - Northfield	Device Malfunction	Nationwide
4 Dec 2024	CLASS II	Medline procedure kits labeled as follows recalled	Medline Industries LP - Northfield	Device Malfunction	Nationwide
4 Dec 2024	CLASS II	Medline procedure kits labeled as follows: Neuraxial Kit recalled	Medline Industries LP - Northfield	Device Malfunction	Nationwide
4 Dec 2024	CLASS II	Medline Nexus Cath Connector, Medline recalled by MEDLINE INDUSTRIES, LP	Medline Industries LP - Northfield	Device Malfunction	Nationwide

More recalls from Medline Industries LP - Northfield

All 792

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	Medline Industries LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	Medline Industries LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	Medline Industries LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	Medline Industries LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	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 6,220

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide