Aligned Medical Solutions initiated an urgent Medical Device Recall notification for convenience kits that contain syringes affected by Medline’s Namic Angiographic Control Syringes with Rotating Adaptor (“Namic RA Syringes”) recall. Convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.
Medline Industries stated that the syringe rotating adaptor on affected devices may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold. If unwinding occurs, there is potential for biohazard exposure, blood loss, and infection. Loose connections or disconnections may introduce air into the line, which could result in air embolism. These conditions may lead to serious injury or death. All units have the potential to exhibit this failure mode.
As of March 13, 2026, Medline Industries has reported four serious injuries and no deaths associated with this issue.
The FDA issued the following Early Alert on April 23, 2026:
The FDA is aware that Aligned Medical Solutions has issued a letter to affected customers recommending certain angiographic syringes included in convenience kits be removed from where they are used or sold. Affected components:
- Medline Device Description: Syringe 10ML Angio W/RA
- Medline Part Number: 80085007
- AMS Device Description: Syringe 10CC Control Polycarb w/ ROT Adapter
- AMS Part Number: 39331
- Lot Number: 70209, 71257, 72311, 75764, 77812, 80915, 86214, 94136, 102993, 108049, 123896, 127096, 135426, 140436, 189197
What to Do
Identify kits with affected syringes. Apply over-labels to all affected kits on hand stating that the affected syringes must be removed and discarded from further use.
On April 1, Aligned Medical Solutions sent all affected customers a letter recommending the following actions:
- Identify, segregate, and quarantine all affected product.
- Add warning labels to all affected kits stating that the affected syringes must be removed and discarded from further use.
- Use the labeling template provided by Aligned Medical Solutions to print labels. This label should be applied in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling.
- If you are a distributor or have resold or transferred this product, notify them of this recall communication.
- Per Medline, due to the risk of serious injury or death, customers are directed to remove and destroy all Namic RA Syringes. If use is unavoidable because failure to proceed would result in patient harm, the Namic RA syringe must be used with extreme caution and vigilance, including manual stabilization of syringe-to-manifold connections and continuous, 100% monitoring during setup and throughout the entire procedure.
- All usage guidelines and the Instructions for Use are provided in Medline’s recall letter. Strict adherence to all usage guidelines and the Instructions for Use are required.
If you or a loved one suffered serious harm (or worse) as a result of a defective medical device in the United States, you should promptly find a defective medical device lawyer in your state who may investigate your medical device claim for you and represent you or your loved one in a defective medical device case, if appropriate.
Click here to visit our website or call us toll-free in the United States at 800-295-3959 to find medical device attorneys in your U.S. state who may assist you.
Turn to us when you don’t know where to turn.
