Lower riskMedical device recall · FDA · Published December 21, 2020
Smiths Medical Portex Acapella DH Vibratory PEP Device Recall: Wrong Model in Shipping Box
Smiths Medical recalls Portex Acap:ell DH Vibratory PEP devices with wrong model in shipping box. This single-use device for respiratory therapy may not fit patients correctly.
“Smiths Medical Portex Acapella DH Vibratory PEP Device Recall: Wrong Model in Shipping Box.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63634-smiths-medical-portex-acapella-dh-vibratory-pep-device-recall-wrong. Based on FDA recall #Z-0874-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0874-2021%22&limit=1).
The FDA announced on 2020-12-21 that Smiths Medical ASD Inc. is recalling Portex Acapella DH Vibratory PEP Devices because shipping boxes may contain the wrong model. Owners should contact the company for a replacement.
How to tell if you have it
Brand: Smiths Medical
Product: Portex Acapella DH Vibratory PEP Device
Model Number: 21-1530
Lot Number: 3988435
UDI: 50788942215304
The hazard
The recall was initiated because the shipping box may contain the wrong model, according to the FDA.
Context
GovInfoNow's records show Smiths Medical ASD, Inc. has had 73 other recalls on record since 2017-06-05. Other recent recalls of similar products include Blom-Singer Classic Voice Prosthesis Recall (2026-06-17), Covidien Shiley Tracheostomy Tube Recall (2026-04-15) and Encore Medical EMPOWR Acetabular System Recall (2026-01-05).
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.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 27 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Michigan, Mississippi, Missouri, Nebraska, New Jersey, North Carolina, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, West Virginia.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.