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)
- Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000073035; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000075896; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000078648; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082387; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082384; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000087087; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093180; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093741; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000095735; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102248; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102694; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000105537; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000107947; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000113756; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000117610; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000118566; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000122251; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000124476; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000126969; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000131544; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000134543; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000139258; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000140972; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000141871; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000148316; Medline SKU # 60010034, UDI/DI each 10193489087246, UDI/DI case 20193489087243, Lot Number: 0000071568; Medline SKU # 60010034, UDI/DI each 10193489087246, UDI/DI case 20193489087243, Lot Number: 0000081594; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000078094; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000090667; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000100891; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000102756; Medline SKU # 60010102, UDI/DI each 10193489040197, UDI/DI case 10193489087246, Lot Number: 0000106009; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000070691; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000074251; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000076643; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000079468; Medline SKU # 60010143, UDI/DI each 10193489040210, UDI/DI case 30193489040214, Lot Number: 0000083282; Medline SKU # 60010143, UDI/DI each 101934
- Units affected
- 1752096 kits
- 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-1718-2026
- 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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