CLASS II Device recall · Reported 27 Jan 2021 · FDA Enforcement Report

Portex Acapella DH Vibratory PEP Device recalled by Smiths Medical ASD

Smiths Medical ASD is recalling Portex Acapella DH Vibratory PEP Device, distributed nationwide in the US. The recall was initiated on 21 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number 21-1530, Lot Number 3988435, UDI 50788942215304

Quantity recalled4440

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0874-2021
FDA event ID: 87034
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 21 Dec 2020
FDA classified: 15 Jan 2021
Reported: 27 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Dec 2020	Recall initiated by company
15 Jan 2021	Classified by FDA	+25 days
27 Jan 2021	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Shipping box may contain wrong model.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado Florida Georgia Iowa Illinois Indiana Kansas Maryland Maine Michigan Missouri Mississippi North Carolina Nebraska New Jersey Ohio Oregon

Questions about this recall

Is Portex Acapella DH Vibratory PEP Device recalled?

Yes. Smiths Medical ASD recalled Portex Acapella DH Vibratory PEP Device on 21 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0874-2021.

Why was it recalled?

Shipping box may contain wrong model.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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