Use caution Medical device recall · FDA · Published October 16, 2024
Medline procedure kits: Catheter connector may not open properly
Medline recalls procedure kits with potential catheter insertion issues if connectors aren't fully open. Affected kits include specific models and lot numbers.
Use caution until it’s fixed
The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Contact the company
Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
What happened, in plain English
Medline is recalling certain procedure kits that may not allow catheters to be inserted correctly if the connector isn't fully open. This could lead to improper catheter placement during medical procedures. Read more at govinfonow.com/recall/53690-medline-procedure-kits-catheter-connector-may-not-open-properly.
Source Summary by GovInfoNow · govinfonow.com/recall/53690-medline-procedure-kits-catheter-connector-may-not-open-properly · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0513-2025
Cite this page
“Medline procedure kits: Catheter connector may not open properly.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53690-medline-procedure-kits-catheter-connector-may-not-open-properly. Based on FDA recall #Z-0513-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0513-2025%22&limit=1).
Why it’s dangerous
The connectors in these procedure kits may not stay fully open, which can prevent catheters from being inserted as intended. This could result in improper catheter placement during medical procedures.
Who’s affected
Healthcare professionals using Medline procedure kits with the specific model numbers and lot numbers listed in the recall. Patients receiving procedures using these kits are at risk of improper catheter placement.
How to tell if you have this one
Check for the following model numbers and lot numbers: CONT EPI 20G W/HUSTEAD (REF PAIN1069B), CSE TRAY (REF PAIN1941), and other kits with specific reference codes and lot numbers listed in the recall notice.
- Brand
Medline- Category
Medical device
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0508-2025 | MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Connector; UDI/DI 10193489490312 (each), 40193489490313 (case), Lot Numbers: 21ABD173, 21EBC720, 21GBG632, 21HBF316, 21IBH392, 21IBM516, 21JBJ902, 21JBP187, 22IBL115, 22KBD213, 22OBI434, 23ABA553, 23ABO991, 23BBG757, 23CBO551, 23EBT535 | 1975 units |
| Z-0509-2025 | 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; 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 | — |
| Z-0510-2025 | MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF EPICATH19 2) 20G EPI CATH SINGLE STERILE, REF EPICATH20; Codes: 1) EPICATH19, UDI/DI 10889942358311(each) 40889942358312(case), Lot Numbers: 22FBX111, 22FBY472, 23FBT886, 23GBL403, 23GBO700, 23GBO701, 23GBO702; 2) EPICATH20, UDI-DI: 10889942358328 (each) 40889942358329 (case), Lot Numbers: 22FBN457, 22HBM699, 22HBN345, 23CBF321, 23DBM670, 23FBK248, 23GBO703, 23GBO704 23GBO705, 23KBG553, 23KBS111 | 5975 units |
| Z-0511-2025 | MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF DYNJRA9043S; 2) ULTRASOUND BLOCK PREP TRAY, REF PAIN1622A; Codes: 1) DYNJRA9043S, UDI/DI 10193489888287(each) 40193489888288(case), Lot Numbers: 23CBE390, 23CBO216, 23EBM309, 23EBP979, 23EBS281, 23GBV099, 23HBG915, 23IBG610, 23IBG611, 23JBQ712, 23KBC341; 2) PAIN1622A, UDI/DI 10193489891690 (each) 40193489891691 (case), Lot Numbers: 21ELA821, 21GLA615, 21KLA308, 22ALA608, 22CLA681, 22ELB088, 22FLB075, 22GLA543, 22KLA019, 23BLA333, 23DLA466, 23HLA896 | 3396 units |
| Z-0512-2025 | MEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF PAIN1423A; 2) CONT. 20G EPI MRI COMPATIBLE, REF PAIN1470A; 3) EPIDURAL CATHETERIZATION KIT, REF PAIN1644; Codes: 1) PAIN1423A UDI-DI: 10193489201826 (each) 40193489201827 (case), Lot Numbers: 22GLA530, 23BLA921, 23DLA373, 23GLA522, 23ILA136, 23JLB217, 23KLA008; 2) PAIN1470A UDI-DI: 10193489957365 (each) 40193489957366 (case), Lot Numbers: 21JLA366, 21JLA956, 21LLA271, 22CLA831, 22DLA301, 22DLB149, 22FLA103; 3) PAIN1644 UDI-DI: 10193489331141 (each) 40193489331142 (case), Lot Numbers: 22FLA985, 23CLA104 | 3006 units |
| Z-0513-2025 | MEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF PAIN1069B; 2) CSE TRAY, REF PAIN1941; 3) TRAY CON EPID 20G NYL W/TUOHY, REF PAIN9023; 4) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN1281 5) TRAY, CONT EPI 20G NYL W/ HUST, REF PAIN9024; Codes: 1) PAIN1069B UDI-DI: 10889942757381 (each) 40889942757382 (case), Lot Numbers: 22GLA433, 23CLA257; 2) PAIN1941 UDI-DI: 10195327365417 (each) 40195327365418(case), Lot Numbers: 23ELB081; 3) PAIN9023 UDI-DI: 10889942448715(each) 40889942448716 (case), Lot Numbers: 22GLA470, 22ILA287; 4) PAIN1281 UDI-DI: 10888277748408(each) 40888277748409(case), Lot Numbers: 22FLA647; 5) PAIN9024 UDI-DI: 10889942448708(each) 40889942448709(case), Lot Numbers: 22FLA675, 22GLA241, 22HLB225, 22ILA288 | 3744 units |
| Z-0514-2025 | MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A; Codes: 1) PAIN1876A UDI-DI: 10195327433666 (each) 40195327433667 (case), Lot Number: 23KLA330 | 360 units |
| Z-0515-2025 | MEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699; 2) L&D CONTINUOUS EPIDURAL TRAY, REF PAIN1699A; Codes: 1) PAIN1699 UDI-DI: 10193489471908 (each) 40193489471909 (case), Lot Numbers: 22FLB063, 23BLB103, 23CLA768; 2) PAIN1699A UDI-DI: 10195327411107 (each) 40195327411108 (case), Lot Numbers: 23GLA369, 23ILA137 | 2592 units |
What to do — step by step
Check Kit Model
Identify the product model and lot number from the kit's label to confirm if it's affected.
Contact Medline
Reach out to Medline for assistance with the recall process if you have the affected kit.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide. Bermuda, Canada, Panama, UAE, US Virgin Islands” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have an affected kit?
Contact Medline directly to determine the next steps for your specific kit.
Similar recalls
Latest medical device recalls
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0513-2025 (October 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0513-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.