Z-1720-2026Class I

Medline Industries, LP

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-04-15

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).

Firm state

Product quantity

762 units

Initiated by

Voluntary: Firm initiated

Reason for recall

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.

Product description

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PROCEDURE TRAY, Medline SKU # DYNJ80513B

Code / lot info

Medline SKU # DYNJ80513B, UDI/DI each 10198459389375, UDI/DI case 40198459389376, Lot Numbers: 26ABH752, 25LBL571, 25KBO421, 25IBF501, 25HBL993, 25FBU283.

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.