Vyaire Medical: Medical Device Recall in 2018 - (Recall #: Z-2826-2018)

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:

The Tri-Flo Subglottic Suction System

Product Classification:

Class I

Date Initiated: June 20, 2018

Date Posted: August 29, 2018

Recall Number: Z-2826-2018

Event ID: 80508

Reason for Recall:

Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. The distal soft tip of the catheter has been identified as having the potential to break off during patient use and result in aspiration of a solid foreign body.

Status: Terminated

Product Quantity: 2150 Units Total

Code Information:

Part number: CM28010; Lot/Serial Numbers: 0001158835 , 0001158836, 0001158837, 0001185564, 0001194114 , 0004008255, 0004008256.

Distribution Pattern:

Domestic Distribution: AZ, CA, CT, FL, GA, IA, IL, IN, MA, MD, MN, NJ, OH, OK, SD, TX, WA, WI.

Voluntary or Mandated:

Voluntary: Firm initiated