Tytek Medical Inc: Medical Device Recall in 2023 - (Recall #: Z-2610-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-303

Product Classification:

Class II

Date Initiated: October 5, 2020

Date Posted: September 27, 2023

Recall Number: Z-2610-2023

Event ID: 92899

Reason for Recall:

Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location

Status: Terminated

Product Quantity: 439146 units

Code Information:

UDI: 00855204008006 All lots produced prior to Oct 5, 2020

Distribution Pattern:

OH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China Israel SPAIN The Netherlands Turkey UAE UK

Voluntary or Mandated:

Voluntary: Firm initiated