BEUDAMED
    FDA Enforcement Class I Ongoing

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.

    Recall: Z-1730-2026 · Reported April 15, 2026

    Enforcement

    Recall Number
    Z-1730-2026
    Event ID
    98598
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medline Industries, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 15, 2026
    Initiation Date
    February 27, 2026
    Classification Date
    April 7, 2026
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.

    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.

    Code Info

    1. Medline SKU # DYNJ30880M, UDI/DI each 10198459446207, UDI/DI case 40198459446208, Lot Number: 25LMJ532; 2. Medline SKU # DYNJ64295A, UDI/DI each 10193489353853, UDI/DI case 40193489353854, Lot Number: 24KMI274.

    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).

    Quantity

    82 kits