Portex Acapella DH Vibratory PEP Device — Class II medical device recall Z-0874-2021
Terminated recall by Smiths Medical ASD Inc., reported 2021-01-27, distributed nationwide. Shipping box may contain wrong model.
| Recall number | Z-0874-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2020-12-21 |
| Classified | 2021-01-15 |
| Reported by FDA | 2021-01-27 |
| Terminated | 2024-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CL, CZ, DE, FR, IT, TH |
| Quantity | 4,440 |
| UPC / GTIN / UDI-DI | 50788942215304 |
| Lot numbers | 3988435 |
| Model numbers | 21-1530 |
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 for recall
Shipping box may contain wrong model.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0874-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.