FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline medical convenience kits recalled for syringe adaptor disconnection risk

OTHERNationwide distributionMedical devices

What this means

Medline medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes may have a defective rotating adaptor that can unwind during use. This could cause the syringe to disconnect from the manifold during a medical procedure. The issue affects 60 kits distributed in the US and 10 other countries.

  • Stop using medical convenience kits with SKU # DYNJ86596, particularly Lot Numbers 24FMI029 or 24DMK138
  • Check if your facility received this kit and set it aside
  • Contact Medline Industries or your healthcare provider for replacement instructions
  • Report any disconnections or injuries to Medline or the FDA
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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
60 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: MINOR PLASTIC-LF, Medline Kit SKU # DYNJ86596

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1723-2026

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