FLUTTER Percussor respiratory device — Class II medical device recall Z-1006-2015
Terminated recall by Aptalis Pharmatech Inc., reported 2015-01-28, distributed nationwide. Customer notification that the device may be difficult to open or close.
| Recall number | Z-1006-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aptalis Pharmatech Inc., Vandalia, OH, United States |
| Recall initiated | 2014-11-13 |
| Classified | 2015-01-22 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2015-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CL, FI, GT, RS |
| Quantity | 49,000 units |
| Lot numbers | S46, S47 |
Product
FLUTTER Percussor respiratory device, packaged one unit per clear plastic package. Product Usage: Product is a percussor device, intended to be used as a mucus clearance device for patients with mucus producing respiratory conditions such as: atelectasis, bronchitis, bronchiectasis, cystic fibrous, chronic obstructive pulmonary disease (COPD) and asthma.
Reason for recall
Customer notification that the device may be difficult to open or close.
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-1006-2015. 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.