Smiths Medical ASD Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Smiths Medical ASD Inc.
Lot Codes / Batch Numbers
Model Number 21-1530, Lot Number 3988435, UDI 50788942215304
Products Sold
Model Number 21-1530, Lot Number 3988435, UDI 50788942215304
Smiths Medical ASD Inc. is recalling Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides P due to Shipping box may contain wrong model.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Shipping box may contain wrong model.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026