FDA Device recall Z-0874-2021
Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Thera…
- FDA Device
- Class II
- terminated
- Published 2021-01-27
On 2021-01-27 the FDA classified a Class II recall of Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Thera… by Smiths Medical Asd, citing shipping box may contain wrong model.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0874-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-21 |
| Published | 2021-01-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Smiths Medical Asd |
| Distribution | US |
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.
Reason
Shipping box may contain wrong model.
Identifiers
| code_info | Model Number 21-1530, Lot Number 3988435, UDI 50788942215304 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0874-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.