Smiths Medical Portex Acapella DH Vibratory PEP Device Recall: Wrong Model in Shipping Box

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Contact the company & request your remedy

Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N, N/A · Minneapolis, MN 55442-1690

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Smiths Medical is recalling Portex Acapella DH Vibratory PEP devices because shipping boxes might contain the wrong model. This could mean the device doesn't fit patients correctly, potentially affecting respiratory therapy effectiveness.

Why it’s dangerous

The shipping box may contain the wrong model, which could lead to the device not fitting patients correctly. This might affect the device's ability to provide proper Positive Expiratory Pressure therapy for respiratory conditions.

Who’s affected

Patients using the Portex Acapella DH Vibratory PEP device for respiratory conditions like cystic fibrosis or COPD are affected. Those who received the device with model number 21-1530 and lot number 3988435 are most at risk.

How to tell if you have this one

Check the shipping box for model number 21-1530 and lot number 3988435. The device is a single-use item for patients with respiratory conditions like cystic fibrosis or COPD.

Brand
Smiths Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Verify the model number on the device is 21-1530 and lot number 3988435.

✎ GovInfoNow

Questions people ask

Why is this device being recalled?

The shipping box may contain the wrong model, which could lead to the device not fitting patients correctly.

What should I do if I have this device?

Check the model number and lot number on the device. If it matches 21-1530 and 3988435, it is part of the recall.

Is there a fix for this issue?

The recall does not mention a remedy, so no action is required beyond checking the model and lot numbers.

Take action

Contact Smiths Medical

We’ve drafted a message you can send Smiths Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0874-2021 — Smiths Medical Smiths Medical

Hello,

I own a Smiths Medical that is covered by recall Z-0874-2021 from Smiths Medical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0874-2021 (December 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0874-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Smiths Medical ASD Inc. recalls Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory

Lower-risk recall