FDA Device Recalls (Class I)

Class I Recall: Medline Medical Convenience Kits, Unwinding Risk, 240 Units

FDA Class I recall initiated February 27, 2026 for Medline medical convenience kits (SKU DYNJ63673D, Lot 25GLA141) containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes. The firm identified through post-market surveillance a risk that the syringe rotating adaptor may unwind during use, potentially causing a loose connection or full disconnection between the syringe and manifold. A total of 240 kits were distributed nationwide (including Puerto Rico) and internationally to Canada, Netherlands, Australia, South Korea, Sri Lanka, Pakistan, Japan, UAE, Singapore, and Slovakia.

Medline Industries Class 1 Recall of Syringe Adaptor Medical Convenience Kits

FDA classified a Class 1 device recall for Medline Industries medical convenience kits containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes. The recall addresses 82 kits (Lot 25LMJ532 and Lot 24KMI274) distributed worldwide due to potential risk of the syringe rotating adaptor unwinding during use, which may cause loose connection or full disconnection between the syringe and manifold. Affected consignees must quarantine product, complete the response form, and remove/discard affected syringes from kits.

Class 1 Device Recall: Medline Medical Convenience Kits with Rotating Syringe Adaptor

FDA classified a Class 1 recall for Medline Industries medical convenience kits containing NAMIC Angiographic Rotating Adaptor control syringes. The firm identified through post-market surveillance a potential risk that the syringe rotating adaptor may unwind during use, resulting in loose connection or full disconnection between the syringe and manifold. Affected products include three SKUs (DYNJ57032D, DYNJ64026C, VASC1650) with 23 lot numbers totaling 2,154 units distributed US nationwide and internationally to 11 countries including Canada, Australia, Japan, and EU member states.