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Recall Observatory FDA recall evidence

Device product

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGRAPHY PACK-LF, Medline SKU DYNJ42367B

Z-1714-2026

February 27, 2026

Class I

Product summary

Firm
Medline Industries, LP
Event
Event 98598
Status
Ongoing
Classification
Class I
Quantity
3120 kits
Official record key
device-enforcement:Z-1714-2026

Official wording

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 information: Medline SKU DYNJ42367B UDI/DI each 10193489211511, UDI/DI case 40193489211512, Lot Numbers: 24FBJ579, 24DBL828, 24DBE055, 24CBG967, 24ABN254, 23LBI540, 23KBF222, 23JBM761, 23JBA270, 23HBY791, 23HBD212, 23GBJ794, 23FBK893, 23EBQ313, 23DBC465.

Distribution pattern: 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).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.