# FDA recall Z-0874-2021

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2020-12-21.

## Product

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.

## Reason for recall

Shipping box may contain wrong model.

## Distribution

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.

## Key facts

- **Recall number:** Z-0874-2021
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-21
- **Report date:** 2021-01-27
- **Termination date:** 2024-07-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0874-2021

## Citation

> AI Analytics. FDA recall Z-0874-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0874-2021. Source: US FDA. Licensed CC0.

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