FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline medical convenience kits with NAMIC syringes recalled for loose adapter connection risk

OTHERNationwide distributionMedical devices

What this means

Medline Industries has recalled certain medical convenience kits containing NAMIC angiographic syringes because the syringe adapter may unwind during use. This could cause the syringe to loosen or disconnect from the manifold, potentially compromising the procedure.

  • Check if you have the affected Medline SKU #DYNJ42892F or DYNJ42892G kits with the listed lot numbers
  • Stop using the recalled kits immediately
  • Contact Medline Industries for instructions on return or replacement
  • Verify lot numbers on your kits against the FDA recall notice
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
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
966 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. DELIVERY PACK, Medline SKU # DYNJ42892F; 2. DELIVERY PACK, Medline SKU # DYNJ42892G.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1727-2026

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