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.

Class I

Recalling firm: Medline Industries, LP
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.
Affected products (lot / model / serial): 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. M
Units affected: 2630369 units
Distribution pattern: 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).
Firm location: Northfield, IL, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type: Devices
Status: Ongoing
Recall number: Z-1712-2026
Recall initiated: February 27, 2026
FDA classification date: April 7, 2026
FDA report date: April 15, 2026
FDA event ID: 98598
Last updated on HTM Vibe: July 24, 2026

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