FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline medical convenience kits recalled for syringe adaptor disconnection risk

OTHERNationwide distribution

Stop using Medline GLOVE PACK 7.0 medical kits

Medline Industries identified a defect in NAMIC Angiographic Rotating Adaptor syringes included in certain medical convenience kits. The syringe adaptor may unwind during use, causing the syringe to loosen or separate from the manifold. This could affect the delivery of contrast media or other fluids during medical procedures.

  • Stop using Medline GLOVE PACK 7.0 kits (SKU DYNJ63673D, Lot 25GLA141) immediately
  • Contact Medline Industries for return or replacement instructions
  • If kits were used in a procedure, consult your healthcare provider about any potential complications
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
240 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: GLOVE PACK 7.0 (15PK), Medline SKU # DYNJ63673D

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1725-2026

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