Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-1993-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.

Product Classification:

Class II

Date Initiated: May 14, 2021

Date Posted: July 7, 2021

Recall Number: Z-1993-2021

Event ID: 87983

Reason for Recall:

One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.

Status: Terminated

Product Quantity: 40 units

Code Information:

Lot Number 4072715

Distribution Pattern:

US Nationwide distribution in the states of PA, MI, MD, FL.

Voluntary or Mandated:

Voluntary: Firm initiated