| | Class 1 Device Recall NAMIC Angiographic Syringe |  |
| Date Initiated by Firm | February 27, 2026 |
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| Date Posted | April 07, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1712-2026 |
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| Recall Event ID |
98598 |
| 510(K)Number | K873955 |
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| Product Classification |
Injector and syringe, angiographic - Product Code DXT
|
| Product | 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. |
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| Code Information |
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.
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| FEI Number |
1417592
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Recalling Firm/
Manufacturer |
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline Industries, LP issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 2/27/2026 via USPS and email. The notice explained the issue, risk associated with syringe disconnection and loose connection, and request customers remove and destroy all Namic RA Syringes. Over-labels will be provided for any affected kits on hand stating that the affected syringes must be removed and discarded from further use. The only exception is in rare circumstances where angiography is urgently required, no alternative device is available, and postponing the procedure would place the patient at significant risk.
Required Action: Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. If you are a distributor or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 2630369 units |
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| Distribution | 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). |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = DXT
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