FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline medical convenience kits recalled for syringe adaptor disconnection risk

OTHERNationwide distribution

Stop using affected Medline robotic procedure kits

Medline has recalled specific batches of medical convenience kits used in robotic procedures because the syringe rotating adaptor may unwind during use. This can cause the syringe to loosen or fully disconnect from the manifold, potentially affecting the procedure. No injuries have been reported.

  • Check your kit SKU number: DYNJ58475F or DYNJ60803J
  • Verify the lot number matches the affected batches listed in the recall
  • Stop using affected kits immediately and isolate them
  • Contact Medline or your hospital supply department for replacement instructions
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
439 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. ROBOTIC PACK, Medline SKU # DYNJ58475F; 2. URO/GEN ROBOTIC PACK, Medline SKU # DYNJ60803J.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1728-2026

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