Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company: Medical Device Recall in 2019 - (Recall #: Z-0716-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿

Product Classification:

Class I

Date Initiated: September 5, 2017

Date Posted: February 13, 2019

Recall Number: Z-0716-2019

Event ID: 81021

Reason for Recall:

Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

Status: Terminated

Product Quantity: 16,104 Japan only

Code Information:

Model # 0552IMJ Lot Numbers: ¿Z588 and Z597

Distribution Pattern:

Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated