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

Thu, 16 Apr 2026 16:33:44 +0000
Medical Devices

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.