Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0874-2021·Announced 2021-01-27

Smiths Medical Recalls Portex Acapella DH Vibratory PEP Devices

Smiths Medical ASD Inc. is recalling 4,440 Portex Acapella DH Vibratory PEP Devices because shipping boxes may contain the wrong model number.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential labeling or packaging error (wrong model in box) without reported injuries or illnesses, fitting the Moderate severity criteria for minor labeling errors or low-risk issues.

Plain-English summary

Smiths Medical ASD Inc. is recalling 4,440 units of the Portex Acapella DH Vibratory PEP Device. The recall is due to a potential shipping error where the box may contain a device with the wrong model number.

The affected devices are identified by Model Number 21-1530, Lot Number 3988435, and UDI 50788942215304. The devices were distributed worldwide, including nationwide in the United States and in specific countries such as Austria, Canada, Chile, the Czech Republic, France, Germany, Italy, and Thailand.

The Portex Acapella DH is a single-patient-use device used to provide Positive Expiratory Pressure (PEP) Therapy for patients with conditions such as Cystic Fibrosis, COPD, asthma, and other lung diseases with secretory problems. Patients and healthcare providers should verify the model number of the device against the packaging to ensure the correct unit is being used.

The recalled product

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.
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Respiratory Therapy
Hazard: mis-labeling
Affected units: 4,440

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

Model Number 21-1530
Lot Number 3988435
UDI 50788942215304

Distribution

Distributed nationwide across the United States.

The notice also names 27 states specifically:

Same manufacturer · Smiths Medical ASD Inc.

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