Angio Packs (AMS6908E and AMS6908F)

  • Risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold, potentially causing biohazard exposure, blood loss, infection, or air embolism.
  • Company: Windstone Medical Packaging dba Aligned Medical Solutions
  • Medical Devices
  • FDA
  • April 16, 2026

Product details

  • Angio Packs (AMS6908E and AMS6908F)

Company announcement

Aligned Medical Solutions initiated a nationwide recall of Angio Packs AMS6908E and AMS6908F on April 2, 2026, due to a risk of the syringe rotating adapter unwinding during use.

This can lead to a loose connection or disconnection between syringes and the manifold.

There have been three instances reported to Medline of inadvertent air injection into the patient, and one instance of exposure to biohazard. No deaths have been reported.

Risk:

Risk of the syringe rotating adapter unwinding during use, which may result in a loose connection and/or full disconnection between the syringes and manifold, potentially causing biohazard exposure, blood loss, infection, or air embolism.

Impacted states: Nationwide

Products:

- AMS6908E Angio Pack

- AMS6908F Angio Pack

Contact

For more information, call 1-800-360-9428 or email fieldcorrectiveaction@alignedmedicalsolutions.com.

View the original FDA notice

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