FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline medical convenience kits recalled for syringe adapter disconnection risk

OTHERNationwide distribution

Stop using affected Medline angiography kits

Medline has recalled certain medical convenience kits used in angiography and neurointerventional radiology procedures. The syringe rotating adapter in these kits can unwind during use, potentially causing a loose connection or complete disconnection between the syringe and manifold. This could interrupt fluid delivery during medical procedures.

  • Check if your facility has any of the affected Medline SKUs: DYNJ57032D, DYNJ64026C, or VASC1650.
  • Verify lot numbers match those listed in the recall notice.
  • Stop using affected kits immediately and contact Medline or the FDA for replacement or disposal instructions.
  • Report any incidents or injuries to Medline and the FDA.
Hazard

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.

Sold states
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).
Affected count
2154 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYNJ57032D; 2. NEURO INTERVENTIONAL RADIOLOGY, Medline SKU # DYNJ64026C; 3. NEURO INERVENTIONAL RADIOLOGY, Medline SKU # VASC1650.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1726-2026

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