Z-0874-2021Class II

Portex Acapella DH Vibratory PEP Device -

Name: Z-0874-2021 Portex Acapella DH Vibratory PEP Device -
Creator: Smiths Medical ASD Inc.
Published: 2020-12-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-12-21 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who... on 2020-12-21. FDA classified it as Class II and gives the reason as "Shipping box may contain wrong model". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0874-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-21
Posted: 2021-01-15
Terminated: 2024-07-11
Recalling firm: Abbott Medical
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.
Product code: BWF Spirometer, Therapeutic (Incentive)
Reason for recall: Shipping box may contain wrong model.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Medical Device Recall Notice (Ref # 3012307300-12/18/2020-014-R) will be sent to customers via tracked email during the week of December 21, 2020. Customers are instructed to send affected product to Smiths Medical.
Quantity in commerce: 4440
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.
Product codes and lots: Model Number 21-1530, Lot Number 3988435, UDI 50788942215304

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0874-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0874-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-15

Product code BWF

K002768Class IIAcapellaDhd Healthcare Corp. / cleared 2000-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)