Hamilton Medical, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0335-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.

Product Classification:

Class II

Date Initiated: June 20, 2017

Date Posted: January 24, 2018

Recall Number: Z-0335-2018

Event ID: 77617

Reason for Recall:

Issue related to the performance of the motor in recalled product. During use, motor may cease to function.

Status: Ongoing

Product Quantity: 176 units

Code Information:

Serial No. 1000 thru 2090; P/N 951001

Distribution Pattern:

US Distribution to IL and TX.

Voluntary or Mandated:

Voluntary: Firm initiated