FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline medical convenience kits recalled for syringe adapter disconnect risk

OTHERNationwide distribution

Stop using affected Medline manifold kits

Medline Industries is recalling five medical convenience kits that contain syringes with rotating adapters that may unwind during use. This could cause the syringe to loosen or fully disconnect from the manifold. No injuries have been reported.

  • Check if you have one of the five affected Medline SKU kits (VASC1061, VASC1074, VASC1198, VASCSHPOFF1, or VASCSLPON1)
  • Verify the lot number matches those listed in the recall notice
  • Stop using the kit immediately if you have an affected lot
  • Contact your Medline representative or the FDA for instructions on returning or replacing the kit
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
1698 kits
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. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1715-2026

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