Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-0874-2021)

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 Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis.

Product Classification:

Class II

Date Initiated: December 21, 2020

Date Posted: January 27, 2021

Recall Number: Z-0874-2021

Event ID: 87034

Reason for Recall:

Shipping box may contain wrong model.

Status: Terminated

Product Quantity: 4440

Code Information:

Model Number 21-1530, Lot Number 3988435, UDI 50788942215304

Distribution Pattern:

Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, MD, ME, MI, MO, MS, NC, NE, NJ, OH, OR, PA, SC, TN, TX, UT, VA, WV and the countries of Austria, Canada, Chile, Czech Republic, France, Germany, Italy, Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated