Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Portex Acapella DH Vibratory PEP Device - Product Usage: a Recalled by Smiths Medical ASD Inc. Due to Shipping box may contain wrong model.

Date: December 21, 2020
Company: Smiths Medical ASD Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD Inc. directly.

Affected Products

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.

Quantity: 4440

Why Was This Recalled?

Shipping box may contain wrong model.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Smiths Medical ASD Inc.

Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report