Neurological Tray

Recall Summary Medline is recalling medical convenience kits containing NAMIC Angiographic Rotating Adaptor Control Syringes used in angiographic and neurointerventional radiology procedures. The syringe's rotating adaptor can unwind during use, causing a loose or complete disconnection between the syringe and manifold. The affected kits were distributed nationwide across the US and to multiple countries including Canada, Australia, Japan, and others.

Product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYNJ57032D; 2. NEURO INTERVENTIONAL RADIOLOGY, Medline SKU # DYNJ64026C; 3. NEURO INERVENTIONAL RADIOLOGY, Medline SKU # VASC1650.
Reason
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.
Classification
Class I
Category
medical device recall
Country
United States
Agency
FDA-DEVICES
Recall date
2026-02-27
Status
Open, Classified
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
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).

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/832ede5c-4c37-4570-a138-a4cf5c7087e3