CLASS I ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report

Namic Angiographic Syringe, labeled as follows recalled

Medline Industries is recalling Namic Angiographic Syringe, labeled as follows: Syringe,Control,-,Pkg, Medline, distributed nationwide in the US. The recall was initiated on 27 Feb 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codes1. Medline SKU 70075027, UDI/DI each 10193489065831, UDI/DI case 30193489065835, Lot Numbers: 0000077215, 0000079109, 0000082289, 0000084363, 0000090369, 0000107045, 0000114900, 0000120770, 0000122275, 0000125531, 0000125834, 0000132127, 0000132132, 0000135020, 0000135023, 0000137279, 0000141698, 0000141699, 0000144189, 0000147731, 0000149644, 0000151436; 2. Medline SKU 70085007, UDI/DI each 10193489065954, UDI/DI case 30193489065958, Lot Numbers: 0000074193, 0000077204, 0000077974, 0000079512, 0000083156, 0000085956, 0000086070, 0000086483, 0000090174, 0000090816, 0000090917, 0000092492, 0000094095, 0000096914, 0000098330, 0000099425, 0000100711, 0000100826, 0000101994, 0000113588, 0000116407, 0000116708, 0000117321, 0000119569, 0000120349, 0000121439, 0000121700, 0000123467, 0000124590, 0000126063, 0000127845, 0000132989, 0000134342, 0000134345, 0000134741, 0000136418, 0000138294, 0000141336, 0000147492, 0000149666, 0000150547, 0000152486, 0000152797, 0000155541, 0000156129, 0000156574, 0000158566, 0000164128, 0000166270, 0000167879, 0000167880, 0000168660, 0000170215, 0000170237, 0000171147, 0000172275, 0000173410, 0000187298, 0000187601, 0000187638; 3. Medline SKU 70085107, UDI/DI each 10193489065961, UDI/DI case 20193489065968, Lot Numbers: 0000075384, 0000096807, 0000133033, 0000147541, 0000154518, 0000167033, 0000179525; 4. Medline SKU 70087007, UDI/DI each 0000075190, G4UDI/DI case 10193489065985, Lot Numbers: 0000075190, 0000075227, 0000078287, 0000089093, 0000090805, 0000090975, 0000093951, 0000094198, 0000094735, 0000096910, 0000101139, 0000101618, 0000105984, 0000106005, 0000107037, 0000109850, 0000110377, 0000111490, 0000111537, 0000112994, 0000113248, 0000113383, 0000113633, 0000117395, 0000121309, 0000122108, 0000123468, 0000124591, 0000127017, 0000128278, 0000129370, 0000130125, 0000132167, 0000134842, 0000138681, 0000140049, 0000153343, 0000156539, 0000157741, 0000159414, 0000166268, 0000167626, 0000167639, 0000169163, 0000172756, 0000176061, 0000178804, 0000182016, 0000186160, 0000187605; 5. Medline SKU 70087107, UDI/DI each 10193489065992, UDI/DI case 30193489065996, Lot Numbers: 0000078897, 0000148131, 0000157141, 0000163681, 0000167174, 0000168020, 0000170851, 0000176075, 0000182252, 0000192254; 6. Medline SKU 70088007, UDI/DI each 10193489066012, UDI/DI case 30193489066016, Lot Numbers: 0000077187, 0000086247, 0000090162, 0000095619, 0000104749, 0000109521, 0000119070, 0000122098, 0000125541, 0000135421, 0000138529, 0000141833, 0000156061, 0000157744, 0000161113, 0000163952, 0000168023, 0000172923, 0000178145, 0000186934; 7. Medline SKU 70095007, UDI/DI each 10193489066036, UDI/DI case 30193489066030, Lot Numbers: 0000074195, 0000077218, 0000078891, 0000083117, 0000084495, 0000086795, 0000088301, 0000089971, 0000096912, 0000109777, 0000114876, 0000118512, 0000118674, 0000120001, 0000120780, 0000121233, 0000121698, 0000122711, 0000128697, 0000131996, 0000135597, 0000137025, 0000138175, 0000140916, 0000147679, 0000150532, 0000159176, 0000161098, 0000161137, 0000166266, 0000167160, 0000170152; 8. Medline SKU 70095107, UDI/DI each 10193489066043, UDI/DI case 30193489066047, Lot Numbers: 0000088193, 0000090703, 0000091441, 0000108589, 0000112295, 0000113957, 0000114591, 0000114910, 0000116253, 0000117305, 0000121678, 0000122871, 0000125011, 0000125016, 0000126248, 0000132001, 0000147323, 0000147489; 9. Medline SKU 70097007, UDI/DI each 10193489066067, UDI/DI case 30193489066061, Lot Numbers: 0000079553, 0000087472, 0000088541, 0000094831, 0000131995, 0000156391, 0000157135, 0000162685; 10. Medline SKU 70097107, UDI/DI each 10193489066074, UDI/DI case 30193489066078, Lot Numbers: 0000075365, 0000079731, 0000087346, 0000094790, 0000100287, 0000104614, 0000105597, 0000109564, 0000110688, 0000118408, 0000119439, 0000122041, 0000124165, 0000125525, 0000131987, 0000133030, 0000137305, 0000147507, 0000147678, 0000153736, 0000161611, 0000165564, 0000181799, 0000184713, 0000185058, 0000190607; 11. Medline SKU 70098107, UDI/DI each 10193489066104, UDI/DI case 30193489066108, Lot Numbers: 0000095693, 0000111595, 0000131985, 0000159175; 12. Medline SKU 80075027. UDI/DI each 10193489066739, UDI/DI case 30193489066733, Lot Numbers: 0000073773, 0000075166, 0000077039, 0000088354, 0000090588, 0000095298, 0000098304, 0000103809, 0000116987, 0000117782, 0000121306, 0000125285, 0000125804, 0000126247, 0000131716, 0000132243, 0000134967, 0000135264, 0000137714, 0000141733, 0000144473, 0000147785, 0000149296, 0000169772, 0000175145, 0000176267, 0000181484, 0000188304, 0000189612, 0000190429, 0000192341; 13. Medline SKU 80085007, UDI/DI each 10193489066838, UDI/DI case 30193489066832, Lot Numbers: 0000069912, 0000070209, 0000070784, 0000070861, 0000071257, 0000071264, 0000071267, 0000072311, 0000073893, 0000074209, 0000074673, 0000074674, 0000075332, 0000075764, 0000077366, 0000077812, 0000079410, 0000080614, 0000080615, 0000080915, 0000081405, 0000081771, 0000083753, 0000084309, 0000085601, 0000085648, 0000085686, 0000086214, 0000086721, 0000086834, 0000087070, 0000088596, 0000088657, 0000089423, 0000089903, 0000090105, 0000094136, 0000094420, 0000096230, 0000099930, 0000102515, 0000102993, 0000102995, 0000102996, 0000103488, 0000103555, 0000106721, 0000106964, 0000107510, 0000107536, 0000107959, 0000108049, 0000108050, 0000109430, 0000109592, 0000110369, 0000110800, 0000110820, 0000110918, 0000111345, 0000112227, 0000112968, 0000114117, 0000115122, 0000115130, 0000115133, 0000115715, 0000116669, 0000117287, 0000117333, 0000117592, 0000119131, 0000119132, 0000120359, 0000120378, 0000120379, 0000120477, 0000120926, 0000121795, 0000121799, 0000121856, 0000121863, 0000122659, 0000123853, 0000123896, 0000124655, 0000125050, 0000126181, 0000126182, 0000126183, 0000126184, 0000127096, 0000127134, 0000130082, 0000130189, 0000130543, 0000130888, 0000131003, 0000131298, 0000132780, 0000132835, 0000133210, 0000134869, 0000135426, 0000135751, 0000135757, 0000137216, 0000137259, 0000139521, 0000140407, 0000140436, 0000140460, 0000141378, 0000142312, 0000143949, 0000144525, 0000144816, 0000144858, 0000146335, 0000146688, 0000147279, 0000147758, 0000148526, 0000148881, 0000149157, 0000149356, 0000149534, 0000149591, 0000150043, 0000150047, 0000150277, 0000150927, 0000150974, 0000151304, 0000151311, 0000151562, 0000151735, 0000153278, 0000153284, 0000154621, 0000154788, 0000155411, 0000155753, 0000156008, 0000156801, 0000157245, 0000157352, 0000157358, 0000157585, 0000157587, 0000158717, 0000159713, 0000159723, 0000159984, 0000160326, 0000160371, 0000161181, 0000162113, 0000162661, 0000162717, 0000162771, 0000162801, 0000164285, 0000164301, 0000164302, 0000165507, 0000165537, 0000166941, 0000167627, 0000168370, 0000168574, 0000170238, 0000170490, 0000170657, 0000170658, 0000170774, 0000172184, 0000172253, 0000172513, 0000172514, 0000172515, 0000172517, 0000172518, 0000173418, 0000173434, 0000173451, 0000174052, 0000174053, 0000174725, 0000174726, 0000174727, 0000175214, 0000175215, 0000175384, 0000175424, 0000175529, 0000176612, 0000176730, 0000176735, 0000176752, 0000177132, 0000177400, 0000177401, 0000177413, 0000177961, 0000178119, 0000178736, 0000179115, 0000179339, 0000179394, 0000179845, 0000179890, 0000179892, 0000179934, 0000180103, 0000180117, 0000180167, 0000181513, 0000181515, 0000181778, 0000181916, 0000182018, 0000182891, 0000182911, 0000183051, 0000183052, 0000183327, 0000183346, 0000183527, 0000184160, 0000184623, 0000185644, 0000185648, 0000185650, 0000185749, 0000185759, 0000185769, 0000186949, 0000186950, 0000187389, 0000187394, 0000187519, 0000187575, 0000187576, 0000187577, 0000187578, 0000187579, 0000188490, 0000188841, 0000188887, 0000188910, 0000189111, 0000189112, 0000189155, 0000189196, 0000189197; 14. Medline SKU 80087007, UDI/DI each 10193489066852, UDI/DI case 30193489066856, Lot Numbers: 0000069251, 0000069917, 0000069924, 0000069955, 0000072771, 0000077785, 0000077961, 0000080251, 0000080640, 0000081441, 0000081509, 0000082978, 0000083583, 0000084511, 0000085710, 0000086143, 0000087262, 0000088591, 0000089167, 0000089223, 0000089900, 0000090951, 0000092215, 0000092427, 0000093891, 0000094516, 0000094933, 0000095447, 0000095467, 0000096380, 0000097051, 0000099609, 0000099610, 0000103018, 0000103037, 0000103071, 0000106714, 0000107645, 0000108268, 0000108568, 0000109958, 0000110755, 0000110822, 0000111582, 0000114281, 0000114307, 0000115713, 0000115967, 0000117330, 0000117797, 0000118671, 0000119940, 0000120026, 0000120051, 0000120053, 0000120316, 0000120975, 0000121434, 0000122584, 0000122603, 0000122604, 0000124663, 0000124680, 0000125249, 0000125286, 0000126308, 0000126556, 0000126585, 0000126586, 0000127955, 0000128344, 0000129498, 0000129499, 0000130238, 0000132000, 0000132003, 0000132374, 0000132699, 0000133607, 0000133695, 0000134500, 0000134502, 0000134897, 0000135265, 0000135316, 0000137719, 0000137820, 0000139116, 0000139172, 0000140262, 0000140397, 0000140962, 0000140966, 0000141839, 0000141861, 0000142855, 0000142869, 0000143982, 0000143993, 0000144660, 0000145515, 0000145586, 0000145926, 0000146475, 0000146982, 0000146986, 0000147169, 0000147982, 0000148028, 0000148577, 0000149312, 0000149318, 0000149583, 0000150969, 0000151045, 0000151063, 0000151741, 0000151761, 0000153191, 0000153280, 0000154083, 0000154130, 0000154176, 0000155027, 0000155028, 0000155581, 0000156012, 0000156816, 0000157314, 0000157315, 0000158415, 0000159552, 0000159560, 0000159582, 0000159978, 0000160369, 0000162471, 0000162480, 0000162481, 0000162624, 0000162625, 0000162649, 0000164092, 0000164096, 0000164097, 0000164098, 0000164291, 0000164356, 0000164369, 0000164412, 0000164549, 0000165293, 0000165504, 0000165591, 0000165654, 0000166238, 0000166269, 0000166502, 0000167633, 0000167696, 0000167868, 0000167920, 0000167921, 0000167958, 0000167971, 0000169151, 0000170064, 0000170157, 0000170159, 0000170191, 0000170618, 0000171787, 0000171814, 0000171818, 0000172763, 0000172766, 0000173231, 0000173232, 0000173233, 0000173234, 0000173247, 0000174297, 0000174299, 0000174312, 0000174326, 0000174327, 0000175651, 0000176231, 0000176507, 0000176617, 0000177589, 0000177957, 0000178097, 0000178099, 0000178800, 0000179118, 0000179119, 0000179357, 0000179358, 0000179359, 0000179906, 0000179922, 0000180197, 0000181163, 0000181815, 0000182069, 0000182717, 0000182776, 0000182777, 0000182835, 0000183531, 0000183532, 0000183591, 0000183662, 0000184146, 0000184178, 0000184332, 0000184352, 0000184776, 0000184777, 0000185117, 0000185118, 0000185660, 0000185661, 0000186183, 0000186212, 0000186254, 0000186265, 0000186566, 0000186876, 0000187378, 0000187393, 0000187532, 0000187533, 0000187581, 0000187583, 0000187602, 0000187628, 0000188843, 0000188844, 0000188889, 0000189198, 0000189242, 0000189684, 0000189685, 0000189686. 15. Medline SKU 80095007, UDI/DI each 10193489066876, UDI/DI case 20193489066873, Lot Numbers: 0000105201, 0000106354, 0000112875, 0000114278, 0000123107, 0000125259, 0000143729, 0000145697, 0000157989, 0000161262, 0000162833, 0000162869, 0000164539, 0000172176, 0000172859, 0000176097, 0000178913, 0000181201, 0000181321, 0000185560; 16. Medline SKU 80095107, UDI/DI each 10193489066883, UDI/DI case 30193489066887, Lot Numbers: 0000075353, 0000076807, 0000077845, 0000078909, 0000080922, 0000082325, 0000086417, 0000091879, 0000092505, 0000094737, 0000096686, 0000097481, 0000100824, 0000103008, 0000104795, 0000107307, 0000109907, 0000112016, 0000114170, 0000114589, 0000116629, 0000117564, 0000120313, 0000120991, 0000121734, 0000125013, 0000126525, 0000128345, 0000129428, 0000131286, 0000132103, 0000136454, 0000139380, 0000143033, 0000143195, 0000144687, 0000144688, 0000145834, 0000150810, 0000151611, 0000151728, 0000153307, 0000153320, 0000154923, 0000154924, 0000162864, 0000163305, 0000163526, 0000164371, 0000165157, 0000166286, 0000167026, 0000167219, 0000169149, 0000170143, 0000170163, 0000175479, 0000176026, 0000177587, 0000177606, 0000179362, 0000180730, 0000181132, 0000182200, 0000185658, 0000190518, 0000191423; 17. Medline SKU 80097107, UDI/DI each 10193489066906, UDI/DI case 30193489066900, Lot Numbers: 0000077040, 0000103845, 0000108241, 0000109897, 0000112900, 0000124191, 0000131659.
Quantity recalled2630369 units

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-1712-2026
FDA event ID
98598
Recalling firm
Medline Industries, Northfield, IL
Classification
Class I
Status
Ongoing
Recall initiated
27 Feb 2026
FDA classified
7 Apr 2026
Reported
15 Apr 2026
Type
Voluntary: Firm initiated
Customers notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category
Other Reasons

Timeline

27 Feb 2026Recall initiated by company
7 Apr 2026Classified by FDA+39 days
15 Apr 2026Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Product as listed by the FDA

NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,TR/FG,RA,-,PKG, Medline SKU 70085107; 4. SYRINGE,12ML,TR/FR,RA,W/RES, Medline SKU 70087007; 5. MTO,SYRINGE,12ML,TR/FG,RA,W/RES, Medline SKU 70087107; 6. SYRINGE,12ML,TR/FR,RA,W/O,RES,-,PKG, Medline SKU 70088007; 7. SYRINGE,10ML,PP/FR,RA,-,PKG, Medline SKU 70095007; 8. SYRINGE,10ML,PP/FG,RA,-,PKG, Medline SKU 70095107; 9. SYRINGE,12ML,W/RES,PP/FR,RA,PG, Medline SKU 70097007; 10. SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG, Medline SKU 70097107; 11. SYRINGE,12ML,PP/FG,RA,W/O,RES, Medline SKU 70098107; 12. SYRINGE,20ML,TR/FR,RA,OEM,PG, Medline SKU 80075027; 13. SYRINGE,10ML,ANGIO,W/RA,-,OEM, Medline SKU 80085007; 14. SYRINGE,12ML,TR/FR,RA,OEM, Medline SKU 80087007; 15. SYRINGE,10ML,PP/FR,RA,-,OEM,-,PG, Medline SKU 80095007; 16. SYRINGE,10ML,PP/FG,RA,OEM,PG, Medline SKU 80095107; 17. SYRINGE,12ML,PP/FG,RA,-,OEM,-,PG, Medline SKU 80097107.

Where it was distributed

Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).

Nationwide CaliforniaPuerto Rico

Questions about this recall

Why was it recalled?

Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Which lots are affected?

1. Medline SKU 70075027, UDI/DI each 10193489065831, UDI/DI case 30193489065835, Lot Numbers: 0000077215, 0000079109, 0000082289, 0000084363, 0000090369, 0000107045, 0000114900, 0000120770, 0000122275, 0000125531, 0000125834, 0000132127, 0000132132, 0000135020, 0000135023, 0000137279, 0000141698, 0000141699, 0000144189, 0000147731, 0000149644, 0000151436; 2. Medline SKU 70085007, UDI/DI each 10193489065954, UDI/DI case 30193489065958, Lot Numbers: 0000074193, 0000077204, 0000077974, 0000079512, 0000083156, 0000085956, 0000086070, 0000086483, 0000090174, 0000090816, 0000090917, 0000092492, 0000094095, 0000096914, 0000098330, 0000099425, 0000100711, 0000100826, 0000101994, 0000113588, 0000116407, 0000116708, 0000117321, 0000119569, 0000120349, 0000121439, 0000121700, 0000123467, 0000124590, 0000126063, 0000127845, 0000132989, 0000134342, 0000134345, 0000134741, 0000136418, 0000138294, 0000141336, 0000147492, 0000149666, 0000150547, 0000152486, 0000152797, 0000155541, 0000156129, 0000156574, 0000158566, 0000164128, 0000166270, 0000167879, 0000167880, 0000168660, 0000170215, 0000170237, 0000171147, 0000172275, 0000173410, 0000187298, 0000187601, 0000187638; 3. Medline SKU 70085107, UDI/DI each 10193489065961, UDI/DI case 20193489065968, Lot Numbers: 0000075384, 0000096807, 0000133033, 0000147541, 0000154518, 0000167033, 0000179525; 4. Medline SKU 70087007, UDI/DI each 0000075190, G4UDI/DI case 10193489065985, Lot Numbers: 0000075190, 0000075227, 0000078287, 0000089093, 0000090805, 0000090975, 0000093951, 0000094198, 0000094735, 0000096910, 0000101139, 0000101618, 0000105984, 0000106005, 0000107037, 0000109850, 0000110377, 0000111490, 0000111537, 0000112994, 0000113248, 0000113383, 0000113633, 0000117395, 0000121309, 0000122108, 0000123468, 0000124591, 0000127017, 0000128278, 0000129370, 0000130125, 0000132167, 0000134842, 0000138681, 0000140049, 0000153343, 0000156539, 0000157741, 0000159414, 0000166268, 0000167626, 0000167639, 0000169163, 0000172756, 0000176061, 0000178804, 0000182016, 0000186160, 0000187605; 5. Medline SKU 70087107, UDI/DI each 10193489065992, UDI/DI case 30193489065996, Lot Numbers: 0000078897, 0000148131, 0000157141, 0000163681, 0000167174, 0000168020, 0000170851, 0000176075, 0000182252, 0000192254; 6. Medline SKU 70088007, UDI/DI each 10193489066012, UDI/DI case 30193489066016, Lot Numbers: 0000077187, 0000086247, 0000090162, 0000095619, 0000104749, 0000109521, 0000119070, 0000122098, 0000125541, 0000135421, 0000138529, 0000141833, 0000156061, 0000157744, 0000161113, 0000163952, 0000168023, 0000172923, 0000178145, 0000186934; 7. Medline SKU 70095007, UDI/DI each 10193489066036, UDI/DI case 30193489066030, Lot Numbers: 0000074195, 0000077218, 0000078891, 0000083117, 0000084495, 0000086795, 0000088301, 0000089971, 0000096912, 0000109777, 0000114876, 0000118512, 0000118674, 0000120001, 0000120780, 0000121233, 0000121698, 0000122711, 0000128697, 0000131996, 0000135597, 0000137025, 0000138175, 0000140916, 0000147679, 0000150532, 0000159176, 0000161098, 0000161137, 0000166266, 0000167160, 0000170152; 8. Medline SKU 70095107, UDI/DI each 10193489066043, UDI/DI case 30193489066047, Lot Numbers: 0000088193, 0000090703, 0000091441, 0000108589, 0000112295, 0000113957, 0000114591, 0000114910, 0000116253, 0000117305, 0000121678, 0000122871, 0000125011, 0000125016, 0000126248, 0000132001, 0000147323, 0000147489; 9. Medline SKU 70097007, UDI/DI each 10193489066067, UDI/DI case 30193489066061, Lot Numbers: 0000079553, 0000087472, 0000088541, 0000094831, 0000131995, 0000156391, 0000157135, 0000162685; 10. Medline SKU 70097107, UDI/DI each 10193489066074, UDI/DI case 30193489066078, Lot Numbers: 0000075365, 0000079731, 0000087346, 0000094790, 0000100287, 0000104614, 0000105597, 0000109564, 0000110688, 0000118408, 0000119439, 0000122041, 0000124165, 0000125525, 0000131987, 0000133030, 0000137305, 0000147507, 0000147678, 0000153736, 0000161611, 0000165564, 0000181799, 0000184713, 0000185058, 0000190607; 11. Medline SKU 70098107, UDI/DI each 10193489066104, UDI/DI case 30193489066108, Lot Numbers: 0000095693, 0000111595, 0000131985, 0000159175; 12. Medline SKU 80075027. UDI/DI each 10193489066739, UDI/DI case 30193489066733, Lot Numbers: 0000073773, 0000075166, 0000077039, 0000088354, 0000090588, 0000095298, 0000098304, 0000103809, 0000116987, 0000117782, 0000121306, 0000125285, 0000125804, 0000126247, 0000131716, 0000132243, 0000134967, 0000135264, 0000137714, 0000141733, 0000144473, 0000147785, 0000149296, 0000169772, 0000175145, 0000176267, 0000181484, 0000188304, 0000189612, 0000190429, 0000192341; 13. Medline SKU 80085007, UDI/DI each 10193489066838, UDI/DI case 30193489066832, Lot Numbers: 0000069912, 0000070209, 0000070784, 0000070861, 0000071257, 0000071264, 0000071267, 0000072311, 0000073893, 0000074209, 0000074673, 0000074674, 0000075332, 0000075764, 0000077366, 0000077812, 0000079410, 0000080614, 0000080615, 0000080915, 0000081405, 0000081771, 0000083753, 0000084309, 0000085601, 0000085648, 0000085686, 0000086214, 0000086721, 0000086834, 0000087070, 0000088596, 0000088657, 0000089423, 0000089903, 0000090105, 0000094136, 0000094420, 0000096230, 0000099930, 0000102515, 0000102993, 0000102995, 0000102996, 0000103488, 0000103555, 0000106721, 0000106964, 0000107510, 0000107536, 0000107959, 0000108049, 0000108050, 0000109430, 0000109592, 0000110369, 0000110800, 0000110820, 0000110918, 0000111345, 0000112227, 0000112968, 0000114117, 0000115122, 0000115130, 0000115133, 0000115715, 0000116669, 0000117287, 0000117333, 0000117592, 0000119131, 0000119132, 0000120359, 0000120378, 0000120379, 0000120477, 0000120926, 0000121795, 0000121799, 0000121856, 0000121863, 0000122659, 0000123853, 0000123896, 0000124655, 0000125050, 0000126181, 0000126182, 0000126183, 0000126184, 0000127096, 0000127134, 0000130082, 0000130189, 0000130543, 0000130888, 0000131003, 0000131298, 0000132780, 0000132835, 0000133210, 0000134869, 0000135426, 0000135751, 0000135757, 0000137216, 0000137259, 0000139521, 0000140407, 0000140436, 0000140460, 0000141378, 0000142312, 0000143949, 0000144525, 0000144816, 0000144858, 0000146335, 0000146688, 0000147279, 0000147758, 0000148526, 0000148881, 0000149157, 0000149356, 0000149534, 0000149591, 0000150043, 0000150047, 0000150277, 0000150927, 0000150974, 0000151304, 0000151311, 0000151562, 0000151735, 0000153278, 0000153284, 0000154621, 0000154788, 0000155411, 0000155753, 0000156008, 0000156801, 0000157245, 0000157352, 0000157358, 0000157585, 0000157587, 0000158717, 0000159713, 0000159723, 0000159984, 0000160326, 0000160371, 0000161181, 0000162113, 0000162661, 0000162717, 0000162771, 0000162801, 0000164285, 0000164301, 0000164302, 0000165507, 0000165537, 0000166941, 0000167627, 0000168370, 0000168574, 0000170238, 0000170490, 0000170657, 0000170658, 0000170774, 0000172184, 0000172253, 0000172513, 0000172514, 0000172515, 0000172517, 0000172518, 0000173418, 0000173434, 0000173451, 0000174052, 0000174053, 0000174725, 0000174726, 0000174727, 0000175214, 0000175215, 0000175384, 0000175424, 0000175529, 0000176612, 0000176730, 0000176735, 0000176752, 0000177132, 0000177400, 0000177401, 0000177413, 0000177961, 0000178119, 0000178736, 0000179115, 0000179339, 0000179394, 0000179845, 0000179890, 0000179892, 0000179934, 0000180103, 0000180117, 0000180167, 0000181513, 0000181515, 0000181778, 0000181916, 0000182018, 0000182891, 0000182911, 0000183051, 0000183052, 0000183327, 0000183346, 0000183527, 0000184160, 0000184623, 0000185644, 0000185648, 0000185650, 0000185749, 0000185759, 0000185769, 0000186949, 0000186950, 0000187389, 0000187394, 0000187519, 0000187575, 0000187576, 0000187577, 0000187578, 0000187579, 0000188490, 0000188841, 0000188887, 0000188910, 0000189111, 0000189112, 0000189155, 0000189196, 0000189197; 14. Medline SKU 80087007, UDI/DI each 10193489066852, UDI/DI case 30193489066856, Lot Numbers: 0000069251, 0000069917, 0000069924, 0000069955, 0000072771, 0000077785, 0000077961, 0000080251, 0000080640, 0000081441, 0000081509, 0000082978, 0000083583, 0000084511, 0000085710, 0000086143, 0000087262, 0000088591, 0000089167, 0000089223, 0000089900, 0000090951, 0000092215, 0000092427, 0000093891, 0000094516, 0000094933, 0000095447, 0000095467, 0000096380, 0000097051, 0000099609, 0000099610, 0000103018, 0000103037, 0000103071, 0000106714, 0000107645, 0000108268, 0000108568, 0000109958, 0000110755, 0000110822, 0000111582, 0000114281, 0000114307, 0000115713, 0000115967, 0000117330, 0000117797, 0000118671, 0000119940, 0000120026, 0000120051, 0000120053, 0000120316, 0000120975, 0000121434, 0000122584, 0000122603, 0000122604, 0000124663, 0000124680, 0000125249, 0000125286, 0000126308, 0000126556, 0000126585, 0000126586, 0000127955, 0000128344, 0000129498, 0000129499, 0000130238, 0000132000, 0000132003, 0000132374, 0000132699, 0000133607, 0000133695, 0000134500, 0000134502, 0000134897, 0000135265, 0000135316, 0000137719, 0000137820, 0000139116, 0000139172, 0000140262, 0000140397, 0000140962, 0000140966, 0000141839, 0000141861, 0000142855, 0000142869, 0000143982, 0000143993, 0000144660, 0000145515, 0000145586, 0000145926, 0000146475, 0000146982, 0000146986, 0000147169, 0000147982, 0000148028, 0000148577, 0000149312, 0000149318, 0000149583, 0000150969, 0000151045, 0000151063, 0000151741, 0000151761, 0000153191, 0000153280, 0000154083, 0000154130, 0000154176, 0000155027, 0000155028, 0000155581, 0000156012, 0000156816, 0000157314, 0000157315, 0000158415, 0000159552, 0000159560, 0000159582, 0000159978, 0000160369, 0000162471, 0000162480, 0000162481, 0000162624, 0000162625, 0000162649, 0000164092, 0000164096, 0000164097, 0000164098, 0000164291, 0000164356, 0000164369, 0000164412, 0000164549, 0000165293, 0000165504, 0000165591, 0000165654, 0000166238, 0000166269, 0000166502, 0000167633, 0000167696, 0000167868, 0000167920, 0000167921, 0000167958, 0000167971, 0000169151, 0000170064, 0000170157, 0000170159, 0000170191, 0000170618, 0000171787, 0000171814, 0000171818, 0000172763, 0000172766, 0000173231, 0000173232, 0000173233, 0000173234, 0000173247, 0000174297, 0000174299, 0000174312, 0000174326, 0000174327, 0000175651, 0000176231, 0000176507, 0000176617, 0000177589, 0000177957, 0000178097, 0000178099, 0000178800, 0000179118, 0000179119, 0000179357, 0000179358, 0000179359, 0000179906, 0000179922, 0000180197, 0000181163, 0000181815, 0000182069, 0000182717, 0000182776, 0000182777, 0000182835, 0000183531, 0000183532, 0000183591, 0000183662, 0000184146, 0000184178, 0000184332, 0000184352, 0000184776, 0000184777, 0000185117, 0000185118, 0000185660, 0000185661, 0000186183, 0000186212, 0000186254, 0000186265, 0000186566, 0000186876, 0000187378, 0000187393, 0000187532, 0000187533, 0000187581, 0000187583, 0000187602, 0000187628, 0000188843, 0000188844, 0000188889, 0000189198, 0000189242, 0000189684, 0000189685, 0000189686. 15. Medline SKU 80095007, UDI/DI each 10193489066876, UDI/DI case 20193489066873, Lot Numbers: 0000105201, 0000106354, 0000112875, 0000114278, 0000123107, 0000125259, 0000143729, 0000145697, 0000157989, 0000161262, 0000162833, 0000162869, 0000164539, 0000172176, 0000172859, 0000176097, 0000178913, 0000181201, 0000181321, 0000185560; 16. Medline SKU 80095107, UDI/DI each 10193489066883, UDI/DI case 30193489066887, Lot Numbers: 0000075353, 0000076807, 0000077845, 0000078909, 0000080922, 0000082325, 0000086417, 0000091879, 0000092505, 0000094737, 0000096686, 0000097481, 0000100824, 0000103008, 0000104795, 0000107307, 0000109907, 0000112016, 0000114170, 0000114589, 0000116629, 0000117564, 0000120313, 0000120991, 0000121734, 0000125013, 0000126525, 0000128345, 0000129428, 0000131286, 0000132103, 0000136454, 0000139380, 0000143033, 0000143195, 0000144687, 0000144688, 0000145834, 0000150810, 0000151611, 0000151728, 0000153307, 0000153320, 0000154923, 0000154924, 0000162864, 0000163305, 0000163526, 0000164371, 0000165157, 0000166286, 0000167026, 0000167219, 0000169149, 0000170143, 0000170163, 0000175479, 0000176026, 0000177587, 0000177606, 0000179362, 0000180730, 0000181132, 0000182200, 0000185658, 0000190518, 0000191423; 17. Medline SKU 80097107, UDI/DI each 10193489066906, UDI/DI case 30193489066900, Lot Numbers: 0000077040, 0000103845, 0000108241, 0000109897, 0000112900, 0000124191, 0000131659.

Where was it sold?

Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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

16 other products · FDA event 98598

This product is part of a recall event; the main page for the event is Medline medical convenience kits recalled by Medline Industries.

ReportedClassRecallCompanyReasonWhere
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS INamic Angiographic Control Syringe, labeled as follows recalledMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesForeign MaterialNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide
CLASS IMedline medical convenience kits recalled by Medline IndustriesMedline IndustriesOtherNationwide

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